High-Dose Immunosuppression and Autologous Transplantation for Multiple Sclerosis (HALT MS) Study

This study is currently recruiting patients.

Verified by National Institute of Allergy and Infectious Diseases (NIAID) August 2006

Sponsors and Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00288626

Purpose

The purpose of this study is to determine the effectiveness of a new treatment for multiple sclerosis (MS), a serious disease in which the immune system attacks the brain and spinal cord. MS can be progressive and severe and lead to significant disability. The study treatment involves the use of high-dose chemotherapeutic drugs to suppress the immune system. The participant’s own (autologous) blood-forming (hematopoietic, CD34+) stem cells are collected before the chemotherapy is given, and then transplanted back into the body following treatment. Transplantation of autologous hematopoietic stem cells is required to prevent very prolonged periods of low blood cell counts after the high-dose chemotherapy.
Condition Intervention Phase

Multiple Sclerosis

Drug: Carmustine
Drug: Etoposide
Drug: Cytarabine
Drug: Melphalan
Drug: Thymoglobulin
Drug: Granulocyte-colony stimulating factor (G-CSF)
Drug: Prednisone

Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title: A Phase II Study of High-Dose Immunosuppressive Therapy (HDIT) Using Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) and Thymoglobulin, and Autologous CD34+ Hematopoietic Stem Cell Transplant (HCT) for the Treatment of Poor Prognosis Multiple Sclerosis

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):
Primary Outcomes: Time to treatment failure during the 5 years after transplant
Expected Total Enrollment: 30

MS is a chronic autoimmune disease of the central nervous system in which myelin, the protective coat that surrounds nerve cells, is damaged or destroyed by autoimmune T cells and macrophages, leading to an eventual loss of neurologic function. In a pilot study in Europe using high-dose chemotherapy, it was observed that 18 of 19 MS patients stabilized or improved clinically, and only one patient showed a new lesion on magnetic resonance imaging (MRI) of the brain at 4.5 years after treatment. Improvement was seen in quality-of-life assessments.

In ITN033AI, high-dose chemotherapy with autologous CD34-selected hematopoietic cell transplantation will be given to confirm the results from the pilot study and to offer therapy to patients with early MS and a poor prognosis. Research studies will be performed in addition to clinical assessments to better understand the effect of the treatment on the activity of MS. High-dose chemotherapy will be used to deplete autoreactive immune cells. These regimens also deplete the bone marrow, the source of blood-forming CD34+ stem cells which causes very low blood counts. Therefore, the participant’s autologous CD34+ hematopoietic stem cells will be collected before high dose immunosuppressive therapy is given and then returned as a transplant post-chemotherapy. Patients will be followed closely after the autologous transplantation since they will be at risk for infections after treatment.

At the beginning of the study, participants will undergo a number of screening and baseline procedures, including a physical exam, blood collection, MS-confirming neurology exams and questionnaires, and MRI procedures. Participants will be given prednisone and granulocyte-colony stimulating factor (G-CSF) to mobilize CD34+ hematopoietic stem cells from the bone marrow into the peripheral blood. When the peripheral blood CD34+ cell count reaches 20,000 cells/ml or greater, these cells will be collected by leukapheresis. In this process, a catheter is placed into a large blood vessel, peripheral blood is withdrawn, and a high speed sedimentation (leukapheresis) device is used to separate and retain the cells required for autologous transplantation. Other blood cells are then returned to the participant’s body. In the laboratory, the CD34+ hematopoietic stem cell graft will be selected and prepared from the leukapheresis collection, and stored until needed for transplant. Seven or more days following the collection of their autologous graft, participants will be hospitalized and receive high-dose chemotherapy consisting of carmustine, etoposide, cytarabine, and melphalan (BEAM) and thymoglobulin. This is followed by transplantation of the autologous hematopoietic cell graft. Participants will remain in the hospital for observation during recovery of their peripheral blood cell counts, as described in the protocol. Participants will receive G-CSF and blood transfusions, if needed, and will be monitored for infections. Following discharge from the hospital, eight study visits will occur over sixty months (five years). During these visits, participants will undergo blood and urine collection, MRI studies, leukapheresis, and MS neurology exams and will complete questionnaires.

Eligibility

Ages Eligible for Study: 18 Years - 60 Years, Genders Eligible for Study: Both

Criteria
Inclusion Criteria:

Diagnosis of relapsing-remitting or progressive-relapsing multiple sclerosis for less than 10 years using McDonald Criteria. More information on this criterion can be found in the protocol.
Score between 3.0 and 5.5 on the Expanded Disability Status Scale (EDSS)
T2 abnormalities on brain MRI consistent with MS
Two or more relapses in 12 months time on interferon (IFN), glatiramer acetate (GA), or mitoxantrone with EDSS increase greater than 0.5, maintained for greater than 3 months OR one relapse on IFN, GA, or mitoxantrone, together with MRI changes consistent with poor prognosis. More information on this criterion can be found in the protocol.
On IFN or GA for at least 6 months before the relapses occur that are counted to satisfy previous inclusion criterion OR have received at least 3 doses of mitoxantrone on a treatment schedule before the relapses occur that are counted to satisfy previous inclusion criterion
Approval by an MS Review Panel to participate in the study. More information on this criterion can be found in the protocol.
In good clinical condition with adequate organ function and without coexisting medical problems that would increase the risk to the participant
Willing to use acceptable methods of contraception
Willing and able to comply with all study requirements
Willing to accept and comprehend irreversible sterility as side effect of therapy

Exclusion Criteria:

Primary progressive MS
Secondary progressive MS without relapses (i.e., progression without exacerbations or relapses) for 12 or more months
Neuromyelitis optica, a disease similar to MS
Initiation of new immunosuppressant treatment after the participant becomes eligible for the protocol or continuance of immunosuppressant drugs after the participant is screened for the protocol. Treatment with IFN, GA, or corticosteroids is permitted after the participant becomes eligible for the protocol.
Lapse of greater than 4 months between the time a participant is eligible for the protocol and initiation of protocol treatment except when judged acceptable by the MS Review Panel
Prior treatment with investigational immunosuppressive agents within 3 months of study eligibility
Prior treatment with natalizumab
History of cytopenia consistent with the diagnosis of myelodysplastic syndrome (MDS)
Active hepatitis B or C infection, cirrhosis, or HIV infection
Uncontrolled diabetes mellitus
Uncontrolled viral, fungal, or bacterial infection. Patients with asymptomatic bacteriuria are not excluded.
Any illness that would jeopardize the ability to tolerate aggressive chemotherapy
Prior history of malignancy, except localized basal cell or squamous skin cancer. Other malignancies for which the subject is judged cured by the administered therapy will be considered on an individual basis.
Hypersensitivity to mouse, rabbit, or Escherichia coli-derived proteins or to iron compounds/medications
Metallic objects implanted in the body that would affect MRI exams
Psychiatric illness, mental deficiency, or cognitive dysfunction
Pregnancy

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier NCT00288626

California
City of Hope National Medical Center, Duarte, California, 91010, United States; Recruiting
Emily Krupka, RN, BSN 626-256-4673 Ext. 64658 ekrupka@coh.org
Stephen J. Forman, MD, Principal Investigator
Harry Openshaw, MD, Principal Investigator

Texas
University of Texas - Southwestern, Dallas, Texas, 75390-9036, United States; Not yet recruiting
Olaf Stuve, MD 214-648-2330 olaf.stuve@utsouthwestern.edu
Olaf Stuve, MD, Principal Investigator

M.D. Anderson Cancer Center, Houston, Texas, 77230-1402, United States; Not yet recruiting
Marilyn S. Davis, RN, CCRC 713-745-4371 msdavis@mdanderson.org
Uday Popat, MD, Principal Investigator

Baylor College of Medicine, Houston, Texas, 77030, United States; Not yet recruiting
George J. Hutton, MD 713-798-8170 ghutton@bcm.tmc.edu
George J. Hutton, MD, Principal Investigator

Washington
Fred Hutchinson Cancer Research Center, Seattle, Washington, 98109-1024, United States; Recruiting
Bernie McLaughlin, RN 206-667-4916 bmclaugh@fhcrc.org
James Bowen, MD, Principal Investigator
Richard Nash, MD, Principal Investigator

Study chairs or principal investigators

Richard A. Nash, MD, Study Chair, Fred Hutchinson Cancer Research Center, Clinical Research Division, University of Washington
Harry Openshaw, MD, Study Chair, Department of Neurology, City of Hope National Medical Center
Stephen J. Forman, MD, Study Chair, Division of Hematology and Hematopoietic Cell Transplantation, City of Hope National Medical Center
James D. Bowen, MD, Study Chair, Department of Neurology, University of Washington
George J. Hutton, MD, Study Chair, The Maxine Messinger MS Clinic, The Methodist Hospital, Baylor College of Medicine
Uday Popat, MD, Study Chair, Department of Blood and Marrow Transplantation, University of Texas, M.D. Anderson Cancer Center
Olaf Stuve, MD, Study Chair, Department of Neurology, Center for Immunology, University of Texas Southwestern Medical School
More Information

Click here for the Immune Tolerance Network Web site

Publications

Fassas A, Nash R. Stem cell transplantation for autoimmune disorders. Multiple sclerosis. Best Pract Res Clin Haematol. 2004 Jun;17(2):247-62. Review.

Muraro PA, Douek DC. Renewing the T cell repertoire to arrest autoimmune aggression. Trends Immunol. 2006 Jan 4; [Epub ahead of print]

Muraro PA, Douek DC, Packer A, Chung K, Guenaga FJ, Cassiani-Ingoni R, Campbell C, Memon S, Nagle JW, Hakim FT, Gress RE, McFarland HF, Burt RK, Martin R. Thymic output generates a new and diverse TCR repertoire after autologous stem cell transplantation in multiple sclerosis patients. J Exp Med. 2005 Mar 7;201(5):805-16. Epub 2005 Feb 28.

Saccardi R, Mancardi GL, Solari A, Bosi A, Bruzzi P, Di Bartolomeo P, Donelli A, Filippi M, Guerrasio A, Gualandi F, La Nasa G, Murialdo A, Pagliai F, Papineschi F, Scappini B, Marmont AM. Autologous HSCT for severe progressive multiple sclerosis in a multicenter trial: impact on disease activity and quality of life. Blood. 2005 Mar 15;105(6):2601-7. Epub 2004 Nov 16.

Tyndall A, Saccardi R. Haematopoietic stem cell transplantation in the treatment of severe autoimmune disease: results from phase I/II studies, prospective randomized trials and future directions. Clin Exp Immunol. 2005 Jul;141(1):1-9. Review.

Study ID Numbers: DAIT ITN033AI; DAIT SCMS2
Last Updated: August 3, 2006
Record first received: February 7, 2006
ClinicalTrials.gov Identifier: NCT00288626
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-10-06

Opexa Commences Phase IIb Multiple Sclerosis Study; Reports Positive Phase I/II Data; Provides Update on Preclinical Progress

September 18, 2006 08:00 AM Eastern Time


BIOWIRE2K

THE WOODLANDS, Texas--(BUSINESS WIRE)--Sept. 18, 2006--Opexa Therapeutics, Inc. (Nasdaq:OPXA), a company involved in the development and commercialization of cell therapies, today announced a number of positive steps in the Company's development including:

-- Its Phase IIb study with Tovaxin(TM) for the treatment of multiple sclerosis has begun. More than 90 attendees from 35 clinical sites attended the investigators' meeting held recently in The Woodlands. These sites have begun screening patients for the 150-patient trial. Opexa expects that the first patients will be enrolled early in the fourth quarter of this year.

-- Positive data from the Phase I/II trial with Tovaxin in multiple sclerosis indicate that after 12 months, patients exhibited a relapse rate reduction of more than 90%.

-- Initiation of animal studies at the University of Texas Medical Branch at Galveston utilizing the Company's autologous adult human stem cell regenerative medicine platform technology.

Commenting on the Phase IIb study, Edward J. Fox, M.D., Ph. D., Clinical Assistant Professor, University of Texas Medical Branch, and director of the MS Clinic of Central Texas (Austin), the lead principal investigator for the Phase IIb study said, "The investigators at the kick-off meeting held in late August expressed a great deal of enthusiasm for this trial and were ready to begin screening patients. We are optimistic that this trial will advance our understanding of Tovaxin as a possible safe and effective treatment for Multiple Sclerosis."

As previously announced, this Phase IIb clinical study will include 150 patients in a multicenter, randomized, double blind, placebo-controlled trial designed primarily to evaluate the efficacy, safety and tolerability of the Tovaxin T Cell vaccination with clinically isolated syndrome (CIS) and relapsing-remitting MS (RR-MS) patients. A total of 100 patients will receive Tovaxin, while 50 will receive placebo. The study is designed as a two-arm, 52-week, parallel-group study, whereby patients will be given five subcutaneous injections at 0, 4, 8, 12 and 24 weeks. The analyses will be performed at the end of the 52-week study to assess the safety and efficacy of Tovaxin. The primary efficacy variable is the cumulative number of gadolinium-enhancing lesions on T1-weighted MRI summed over the Week 28, 36, 44, and 52 MRIs. The secondary efficacy variables are the cumulative number of new gadolinium-enhancing lesions at Weeks 28-52, the change in T2-weighted lesion volume, and the annualized relapse rate.

All patients who complete the trial will be eligible to participate in an optional one-year extension study, in which they will receive Tovaxin open-label. The open-label study is being planned under a different protocol that will be submitted to the FDA.

David McWilliams, president and chief executive officer of Opexa said, "We are pleased to begin this trial and based on recent data from our Phase I/II studies, we believe that those early results support the rationale for moving forward. We now have 12-month data from our two earlier studies, which indicate that the patients treated had a greater than 90% annualized relapse rate reduction, as compared with their prior history."

Opexa also announced that it has advanced its preclinical program in diabetes with the initiation of animal studies at the University of Texas Medical Branch at Galveston. These studies will utilize Opexa's adult human stem cell regenerative medicine platform technology. This is a novel process that utilizes a specific set of conditions in which monocyte-derived stem cells are able to differentiate into insulin-producing islet-like clusters. This process offers several distinct advantages over present adult stem cells technologies for diabetes. One promise of this technology is the ability to easily isolate stem cells from an individual's circulating monocytes (white blood cells), expand and differentiate them into insulin-producing islet-like cluster and administer them back into the same patient. This autologous approach has the advantage of avoiding the problem of transplant rejection and may eliminate the need for immunosuppressant drugs which are often associated with current transplantation. Data from the animal studies are expected in the first quarter of 2007.

About Opexa Therapeutics

Opexa Therapeutics develops and commercializes cell therapies to treat several major disease areas such as MS, rheumatoid arthritis, pancreatic and cardiac conditions. Opexa has exclusive license from Baylor College of Medicine for individualized cell therapies and has initiated a Phase IIb clinical trial to evaluate effectiveness in treating MS. The Company holds the exclusive worldwide license for an autologous T cell vaccine for rheumatoid arthritis from the Shanghai Institutes for Biological Sciences, Chinese Academy of Sciences of the People's Republic of China. Opexa also holds the exclusive worldwide license from the University of Chicago, through its prime contractor relationship with Argonne National Laboratory, for patents relating to the use of adult pluripotent stem cells derived from patients' own circulating blood. For more information, visit the Opexa Therapeutics website at www.opexatherapeutics.com.

Safe Harbor Statement

This press release contains "forward-looking statements," including statements about Opexa Therapeutics' growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. These forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to Opexa Therapeutics' ability to obtain additional funding, develop its stem cell technologies, achieve its operational objectives, and obtain patent protection for its discoveries, that may cause Opexa Therapeutics' actual results to be materially different from any future results expressed or implied by such forward-looking statements. Opexa Therapeutics undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

©2005 PharmaFrontiers Corp. All Rights Reserved

New Data Confirmed Antibodies To Copaxone® Do Not Impact Its Established And Sustained Long-Term Efficacy In Multiple Sclerosis

Article Date: 06 Oct 2006 - 0:00am (PDT)

New data presented today at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Madrid, Spain, showed that antibodies to COPAXONE® (glatiramer acetate injection) developed in all patients with multiple sclerosis (MS) treated with COPAXONE®, but did not interfere with the efficacy of the drug. Over a mean treatment period of more than six years, patients in this cross-sectional study who were continuously treated with COPAXONE® experienced only a minimal increase in their EDSS score, indicating that the long-term efficacy of the drug was not compromised by treatment-related antibodies.

Studies have shown that neutralizing antibodies (Nabs) develop in 5 percent to 45 percent of all MS patients treated with interferon beta (IFN-â). The presence of Nabs to IFN-â may negatively alter the therapeutic effectiveness of this class of disease modifying drugs which includes IFN-â-1a SC (Rebif®), IFN-â-1b SC (Betaseron®), and IFN-â-1a IM (Avonex®). Patients who test positive for NAbs are more likely to have reduced therapeutic benefits from their interferon beta treatment (measured by the reduction in relapse rate, the reduction in disability progression and the disease activity as evidenced by brain magnetic resonance.

"Neutralizing antibodies against IFNs are therefore an important issue for MS management, as their development appear to diminish their clinical efficacy," said Professor Dimitrios Karussis, Department of Neurology, Hadassah University Hospital, Ein-Karem, Jerusalem. "Our data confirms that antibodies to COPAXONE® which develop in all patients do not neutralize the drug's biological activity and do not compromise its established sustained long term effectiveness." he added.

Recent guidelines on Nabs to beta interferons, produced by the European Federation of Neurological Societies (EFNS), recommend that all people with MS being treated with IFN-â be screened after 12 and 24 months of treatment to determine the existence of anti-IFN-â Abs, and that those who have persistently high levels of NAbs after re-testing 3-6 months after the first results, should have their interferon beta treatment discontinued. Furthermore, it is recommended that since NABs are cross-reactive, switch from one IFN preparation to another is of no clinical benefit.

About the Study

Patients in this study (n=126) who had received COPAXONE® (glatiramer acetate injection) from 2 years to 15 years were surveyed to determine levels and types of antibodies to COPAXONE® and to correlate these parameters with treatment outcomes. Serum samples were collected from study participants, and were analyzed for the presence of antibodies to COPAXONE® using ELISA E (enzyme-linked immunosorbent assay) methodology. Clinical data, including the current and previous Expanded Disability Status Scale (EDSS) scores, and the relapse rates, were also collected at the time the serum samples were taken.

Over the mean COPAXONE® treatment period of 6.65 years, sera from only six patients demonstrated minimal in vitro neutralizing activity. In addition, patients were clinically stable for the whole COPAXONE® treatment period, showing a minimal mean increase in EDSS score of 0.65 (mean annual increase = 0.10 per patient). Despite mean disease duration of 10.75 years, the majority of patients (77 percent) surveyed had an EDSS score of less than 4.0, a stage at which they were still fully ambulatory.

In order to further study the subject of NABs to IFNs, Teva Neuroscience, Inc., recently initiated the first-ever study designed to examine how the implementation of regularly scheduled IFN-â NAbs tests in MS patients receiving high-dose IFN-â therapy ultimately affects treatment patterns, versus the usual care of IFN-â patients. The study, called the NAbs Count Study, began enrolment in July, 2006, in approximately 130 centers across the United States.

About COPAXONE®

Current data suggest COPAXONE® (glatiramer acetate injection) is a selective MHC class II modulator. COPAXONE® is indicated for the reduction of the frequency of relapses in RRMS. The most common side effects of COPAXONE® are redness, pain, swelling, itching, or a lump at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.

COPAXONE® is now approved in 44 countries worldwide, including the United States, Canada, Mexico, Australia, Israel, and all European countries. In Europe, COPAXONE® is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. In North America, COPAXONE® is marketed by Teva Neuroscience, Inc.

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80% of Teva's sales are in North America and Europe. Teva's innovative R&D focuses on developing novel drugs for diseases of the central nervous system.

Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management's current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause Teva's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to Teva's ability to rapidly integrate Ivax Corporation's operations and achieve expected synergies, Teva's ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic products, the impact of competition from brand-name companies that sell or license their own brand products under generic trade dress and at generic prices (so called "authorized generics") or seek to delay the introduction of generic product, the impact of consolidation of our distributors and customers, regulatory changes that may prevent Teva from exploiting exclusivity periods, potential liability for sales of generic products prior to a final resolution of outstanding litigation, including that relating to the generic versions of Allegra®, Neurontin®, Oxycontin® and Zithromax®, the effects of competition on Copaxone® sales, including as a result of the expected reintroduction of Tysabri® into the market, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, the regulatory environment and changes in the health policies and structures of various countries, Teva's ability to successfully identify, consummate and integrate acquisitions, potential exposure to product liability claims, dependence on patent and other protections for innovative products, significant operations worldwide that may be adversely affected by terrorism or major hostilities, environmental risks, fluctuations in currency, exchange and interest rates, operating results and other factors that are discussed in Teva's Annual Report on Form 20-F and its other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.

New Pharmacoeconomic Data on TYSABRI(R) Demonstrate Significant Reduction in Steroid Use and Hospitalizations in Patients with Multiple Sclerosis

Oct 6 2006, 9:00 AM EST

BIOWIRE

Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced that data to be presented today at the Academy of Managed Care Pharmacy's (AMCP) 2006 Educational Conference in Chicago, IL show that in Phase III studies TYSABRI(R) (natalizumab) therapy significantly reduced corticosteroid use and hospitalizations, and increased the proportion of MS patients with no disease activity. Findings will also be presented that demonstrate the positive impact of TYSABRI on a number of health-related quality of life of measures (QoL) and the cost-effectiveness of MS therapies.

Data Demonstrate TYSABRI Reduced Corticosteroid Use, Hospitalizations and Increases the Proportion of Disease-Free Patients

Data presented today from the AFFIRM monotherapy study (two-year, randomized, multi-center, placebo-controlled, double-blind study of 942 patients conducted in 99 sites worldwide), showed the impact of TYSABRI on two pre-specified endpoints, the annualized rate of relapses requiring corticosteroid use and the annualized rate of hospitalizations due to MS. Data showed there was a 69% relative reduction in the annualized rate of relapses requiring steroids for patients treated with TYSABRI compared to those treated with placebo (0.133 in the TYSABRI group vs. 0.432 in the placebo group(p<0.001)). The study also showed that TYSABRI therapy resulted in a 65% relative reduction in the annualized rate of MS-related hospitalizations over two years (0.034 in the TYSABRI group vs. 0.097 in the placebo group(p<0.001)).

A post-hoc analysis was also conducted to determine the proportion of patients free of disease activity over two years. To determine this, a retrospective analysis was conducted to evaluate both clinical and magnetic resonance imaging (MRI) measures. Patients with no disease activity were defined as patients who experienced no additional relapses or progression of physical disability and exhibited stable MRI measures without any new gadolinium-enhancing, T2-hyperintense, or T1-hypointense lesions. Data presented today suggest that TYSABRI significantly increased the proportion of disease-free patients by 79% over two years compared with placebo (28% vs. 6%, respectively; p<0.001).

Cost Effectiveness of MS Therapies

A model was constructed by Xcenda, formerly Applied Health Outcomes, to compare the cost per relapse avoided among the five approved disease-modifying MS therapies to treat relapsing forms of MS. Overall cost of therapy was calculated using the US wholesale acquisition drug cost, and costs associated with drug administration, patient monitoring and treatment of relapses. The costs associated with adverse events were not assessed as part of this model. Effectiveness was defined as the number of relapses avoided with treatment, which was calculated as the number of relapses for a non-treated population multiplied by published relapse rate reductions for the therapies.(1) Based on the model developed, the cost per relapse per year avoided was lowest for TYSABRI. The cost per relapse avoided for TYSABRI was between $12,730 and $23,274 lower than that of the other approved disease-modifying therapies.

Data Show TYSABRI Had Improvement in Quality of Life Assessments

Quality of Life (QoL) was assessed using three different measures, the Multiple Sclerosis Quality of Life Inventory (MSQLI), the Short Form-36 Health Survey (SF-36), which is a component of the MSQLI, and a Visual Analogue Scale (VAS). The MSQLI is an MS-specific battery of 10 scales that measure disease impact on QoL, including fatigue, pain, sexual function, bowel and bladder function, visual impairment, mental health and need for social support. The SF-36 is comprised of 36 questions designed to assess patients' physical and mental well-being. General well-being was also measured using the VAS.

In data presented today from the AFFIRM study, patients in the TYSABRI-treated group realized a significant improvement in physical measures of the SF-36 compared with a decline in the placebo-treated group (p=0.003). A significant improvement was also seen in the mental component of the SF-36 in patients treated with TYSABRI compared with a decline in the placebo-group (p=0.011). Significant benefits were also seen using the VAS (p=0.007).

About TYSABRI

In the US, TYSABRI is approved as a monotherapy treatment for relapsing forms of MS. TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Patients should be monitored at regular intervals for any new or worsening signs or symptoms suggestive of PML. Because of the increased risk of PML, TYSABRI is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, alternate MS therapies. It is available in the US only through a restricted distribution program called the TOUCH Prescribing Program. According to product labeling, after two years, TYSABRI treatment led to a 67% relative reduction (p<0.001) in the annualized relapse rate compared to placebo and reduced the relative risk of disability progression by 42% (p<0.001). TYSABRI treatment also resulted in sustained and statistically significant reductions in brain lesion activity as measured by MRI. Changes in MRI findings often do not correlate with changes in the clinical status of patients (e.g., disability progression). The prognostic significance of the MRI findings in these studies has not been evaluated.

In the European Union, TYSABRI is indicated as a single disease-modifying therapy in highly active relapsing-remitting MS patients. Because of the increased risk of PML, it is for patients with high disease activity despite treatment with a beta-interferon or in patients with rapidly evolving severe relapsing-remitting MS. According to product labeling in the EU, after two years, TYSABRI treatment led to a 68% relative reduction (p<0.001) in the annualized relapse rate compared to placebo and reduced the relative risk of disability progression by 42-54% (p<0.001).

Serious adverse events that occurred in TYSABRI-treated patients included hypersensitivity reactions (e.g., anaphylaxis), infections, depression and gallstones. In MS trials, the incidence and rate of other serious and common adverse events, including the overall incidence and rate of infections, were balanced between treatment groups. Herpes infections were slightly more common in patients treated with TYSABRI. Serious opportunistic and other atypical infections have been observed in TYSABRI-treated patients, some of whom were receiving concurrent immunosuppressants. Common adverse events reported in TYSABRI-treated patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain, lower respiratory infections, rash, gastroenteritis, abdominal discomfort, vaginitis, and diarrhea.

For more information about TYSABRI please visit www.tysabri.com, www.biogenidec.com or www.elan.com, or call 1-800-456-2255.

About Biogen Idec

Biogen Idec creates new standards of care in oncology, neurology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.

About Elan

Elan Corporation, plc is a neuroscience-based biotechnology company committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world. Elan shares trade on the New York, London and Dublin Stock Exchanges. For additional information about the company, please visit www.elan.com.

Safe Harbor/Forward Looking Statements

This press release contains forward-looking statements regarding TYSABRI. These statements are based on the companies' current beliefs and expectations. The commercial potential of TYSABRI is subject to a number of risks and uncertainties. Factors which could cause actual results to differ materially from the companies' current expectations include the risk that we may be unable to adequately address concerns or questions raised by FDA or other regulatory authorities, that concerns may arise from additional data, that the incidence and/or risk of PML or other opportunistic infections in patients treated with TYSABRI may be higher than observed in clinical trials, or that the companies may encounter other unexpected hurdles. Drug development and commercialization involves a high degree of risk. For more detailed information on the risks and uncertainties associated with the companies' drug development and other activities, see the periodic and current reports that Biogen Idec and Elan have filed with the Securities and Exchange Commission. The companies assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

(1) The relapse reduction rates used were: TYSABRI was 67%, AVONEX (Interferon beta-1a IM) 32%, Betaseron(R) (Interferon beta-1b) 34%, Copaxone(R) (glatiramer acetate) 29%, and Rebif(R) (Interferon beta-1a SC) 32%.

Hope, unfulfilled promises on stem cell work

By Sally Lehrman | October 1, 2006

IN AUGUST, Advanced Cell Technology reported in the journal Nature that it had created embryonic stem cells for the first time using a technique that avoids destroying an embryo. Journalists leapt on the news because it meant researchers might sidestep moral objections that had plagued the technology. Just the previous month, President Bush had vetoed Congress' modest extension of federal funding for the science.

But despite news of a breakthrough at the company's lab in Worcester, the work didn't live up to the buzz. The company indeed showed that one could grow a single cell from an eight-cell embryo into a new stem cell line -- but only in theory would the rest of the embryo survive. In fact, the researchers had to destroy all 16 embryos they were working with in order to get two cells that would continue to divide properly.

Journalists blamed their confusion on overblown statements in both the company press release and Nature's media advisory. But one might expect more skepticism about a field that has shown itself prone to hyperbole.

Politicians and voters need to be cautious, too. In Massachusetts, Democratic gubernatorial candidate Deval Patrick wants to issue bonds to support stem cell research. The field ``provides hope," his policy book carefully notes, ``to those suffering from Alzheimer's disease, diabetes, multiple sclerosis or any number of other chronic genetic ailments."

But California's experience should be a warning to those expecting quick progress. In 2004, voters passed an initiative to provide $3 billion to embryonic stem cell research on the promise that the technology could ``cure" a stunning 70-plus diseases. But legal and legislative battles over conflicts of interest and public accountability stalled research grants for the next two years. Finally, in July, Governor Arnold Schwarzenegger lent $150 million from the state general fund to get research grants started.

Research into embryonic stem cells has great potential. These cells seem able to renew themselves continuously and produce any type of specialized cell necessary to restore damaged tissue. But learning how to create them efficiently and grow them predictably is the first of many technical challenges.

Researchers must figure out how to direct them to integrate properly into the body, too. Certain diseases, including Alzheimer's, aren't candidates for stem cell treatment until the underlying condition is better understood.

Scientists in many fields have sometimes exaggerated the importance of their work. But stem cell researchers seem uniquely inclined toward dramatic claims.

In 2004, Korean scientist Hwang Woo Suk faked the landmark achievement of extracting the first stem cells from a cloned human embryo. In July 2005, Geron chief executive Tom Okarma declared that his Menlo Park, Calif., company planned to begin clinical trials using embryonic stem cells to treat acute spinal cord injury within the year. Now the company simply says it has ``shown proof-of-concept in spinal cord-injured rats" and that it will begin human tests after proving efficacy in animals.

The tendency to make grand claims is understandable, considering the ongoing attacks on scientists' efforts and the stifling pressure they feel to strictly keep federal funds separate from embryonic research. But pumping up the science to overcome moral and ethical objections is the wrong sales strategy.

Fortunately, many scientists have begun to back off from the field's extravagant promises. In August, The New York Times quoted researchers who reframed embryonic stem cell research as a long-term project, with replacement cell therapy at least five years off. Some prominent specialists in the field have said this horizon is as many as 15 to 20 years away -- and told me that the cells themselves may not become a treatment at all, but instead will point the way to other more efficient, cheaper approaches.

Embryonic stem cells may help answer some of the most important questions in human biology. When I interviewed him last year, Gordon Keller, who studies how to direct these cells to specialize into blood, cardiovascular, liver, and pancreatic cells, urged his colleagues to stick to the facts. ``We need to be careful that we're not overselling the immediate potential," said Keller, who becomes director of the McEwen Centre for Regenerative Medicine in Toronto next year.

In a 2005 survey of 2,200 Americans, the Johns Hopkins Genetics & Public Policy Center found that two-thirds of respondents supported or strongly supported embryonic stem cell research. But by telling tall tales about imminent cures, embryonic stem cell researchers squander their credibility. Why risk losing the public trust? The basic science is thrilling enough.

Sally Lehrman reports on health and science for Scientific American, the radio program ``The DNA Files," and other media.

MultiCell Technologies Announces Strategic Initiatives for 2006 and 2007; Company to Focus on Advance of First-in-Class Immune-based Drug Candidates i

October 05, 2006 06:30 AM Eastern Time


SAN DIEGO--(BUSINESS WIRE)--MultiCell Technologies, Inc. [OTCBB:MCET], developing first-in-class drugs based on advanced immune system modulation and other proprietary technologies, has announced its Strategic Initiatives for the remainder of 2006 and beyond. The announcement was made by Dr. Stephen Chang, President and Chief Executive Officer of MultiCell.

MultiCell is currently leveraging its platform technologies to develop new drug candidates that effectively ward off disease by boosting the immune response. The Company’s strategic business plan to address multibillion-dollar market opportunities consists of the following initiatives:

Continued expansion of its portfolio of cutting-edge immune-modulation platform technologies and drug candidates to support product development and capitalize on licensing opportunities
Advanced development of the Company’s new drug pipeline, bringing its four lead therapeutics programs to next phase human clinical trials
Support for existing research and development programs, and establishment of additional programs and strategic partnerships to ensure success and shorten time to market
MultiCell is an innovator in the science of modulating the human immune system with unique platform technologies, focusing on the development of breakthrough drugs to treat serious autoimmune diseases, such as multiple sclerosis, type-1 diabetes, and infectious disease such as influenza. Currently, the market for therapies that address these diseases is estimated at $8 billion worldwide.

The Company is focused on three disease targets with products already in the clinic: multiple sclerosis (MS), type-1 diabetes, and influenza. Its therapeutic pipeline includes MCT-125, a first-in-class treatment for chronic fatigue in MS patients; MCT-175, for the treatment of relapsing-remitting MS; MCT-275 for the treatment of type-1 diabetes; and MCT-465, a TLR agonist adjuvant therapy targeting virus infection.

“MultiCell has laid the foundation for a solid platform of therapeutic candidates that target very large patient populations, including people with diabetes and multiple sclerosis, who desperately need effective new treatments,” said Dr. Chang. “We have been encouraged by the extremely positive results of our drug candidates, in particular MCT-125 which has already completed a 138 patient Phase II human clinical trial, and we look forward to commencing future human clinical trials as we drive our new therapies to the market.”

Strategic Initiative 1 — Continued development of the Company’s advanced product pipeline, bringing current drug development candidates to next phase of human clinical trials. These first-in-class therapeutic products include:

MCT-125 for the treatment of chronic fatigue in MS patients. MCT-125 completed a 138 patient Phase II clinical trial demonstrating significant efficacy in reducing chronic fatigue in MS patients. There is no drug specifically approved for the treatment of chronic fatigue in MS patients anywhere in the world.

MCT-175 for the treatment of relapsing-remitting MS. MCT-175, in preclinical development for the treatment of relapsing-remitting MS, targets disease specific autoaggressive T-cells that destroy the myelin sheath of nerve cells. MCT-175 successfully ameliorated the disease in animal models.

MCT-275 for the treatment of type-1 diabetes. MCT-275, in preclinical development, targets disease-specific autoaggressive T-cells that destroy insulin producing cells in the pancreas. MCT-275 completely reversed the type-1 diabetic phenotype and prolonged life in animal models.

MCT-465 for the treatment of virus infection. MCT-465 in preclinical studies successfully reduced pulmonary influenza virus levels 1,000-fold in animal models, and has demonstrated effectiveness in reducing virus levels of HIV and HCV in animal models.

Strategic Initiative 2 — Expand the portfolio of cutting-edge platform technologies to support product development and capitalize on licensing opportunities.

MultiCell’s intellectual property portfolio currently contains more than 40 issued, pending or applied-for patents that cover its novel drug development platform technologies and new drug candidates. The Company is leveraging its breakthrough technology platforms to develop a new generation of unique therapeutic candidates which stimulate or suppress the immune system to treat such conditions as multiple sclerosis, diabetes, and infectious disease.

MultiCell believes it has a solid platform of therapeutic pipeline candidates in key, high-growth market segments. Currently, the market for candidates addressing these diseases is estimated at approximately $8 billion worldwide (based on total worldwide sales in 2004). The Company plans to pursue strategic alliances in order to penetrate the various markets for its new drug candidates.

With a strategic shift in focus to therapeutic programs and technologies, the Company expects future cash requirements to increase significantly as the Company advances therapeutic programs into clinical trials. Until the Company is successful in raising additional funds, the Company may have to prioritize therapeutic programs and delays may be necessary in some or all development programs. As a result, the Company is actively seeking to raise additional funds for its current operations through the sale of our common and/or preferred stock, warrants, and/or the issuance of debt. Due to the Company’s current financial condition, the Company does not believe that existing funds and existing sources of funds (royalties and grant income) are sufficient to allow the Company to continue as a going concern beyond October 31, 2006.

About MultiCell Technologies, Inc.

MultiCell Technologies, Inc. is an integrated biopharmaceutical company committed to the development of breakthrough therapeutics based on a portfolio of therapeutic candidates and patented drug development technology. MultiCell’s drug development program is focused on modulation of the immune system. The Company's lead drug candidates include drugs to treat MS-related chronic fatigue, relapsing-remitting multiple sclerosis, type-1 diabetes, and infectious disease. The Company also holds unique cell-based technology for use in drug discovery screening applications and the production of therapeutic proteins, and is the leading producer of immortalized human hepatocyte cell lines needed by the biotechnology and pharmaceutical industries to develop new drugs and therapeutics. For more information about MultiCell Technologies, please visit http://www.MultiCelltech.com. For investor information about MultiCell, please visit http://www.trilogy-capital.com/tcp/multicell. For current stock price quotes and news, visit http://www.trilogy-capital.com/tcp/multicell/quote.html. To view the Company’s Investor Fact Sheet, visit http://www.trilogy-capital.com/tcp/multicell/factsheet.html. To listen to an archived investor conference call, visit http://www.trilogy-capital.com/tcp/multicell/conference/html.

Forward-Looking Statements

Any statements in this press release about MultiCell's expectations, beliefs, plans, objectives, assumptions, or future events or performance are not historical facts and are forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). These statements are often, but not always, made through the use of words or phrases such as "believe," "will," "expect," "anticipate," "estimate," "intend," "plan," "forecast," "could," and "would." Examples of such forward-looking statements include statements regarding plans to use funds from any financing for general corporate purposes, MultiCell's ability to advance MCT-125 into a Phase IIb/III clinical trial, the ability of MultiCell to accelerate any of its therapeutic programs, or the ability of MultiCell to commercialize any new therapeutic. MultiCell bases these forward-looking statements on current expectations about future events. They involve known and unknown risks, uncertainties, and assumptions that may cause actual results, levels of activity, performance, or achievements to differ materially from those expressed or implied by any forward-looking statement. Some of the risks, uncertainties, and assumptions that could cause actual results to differ materially from estimates or projections in the forward-looking statements include, but are not limited to, the risk that we might not achieve our anticipated clinical development milestones, receive regulatory approval, or successfully commercialize our lead drug candidates as expected, the market for our products will not grow as expected, and the risk that our products will not achieve expectations. For additional information about risks and uncertainties MultiCell faces, see documents MultiCell files with the SEC, including MultiCell's report on Form 10-KSB for the fiscal year ended November 30, 2005, and all our quarterly and other periodic SEC filings. MultiCell claims the protection of the safe harbor for forward-looking statements under the Act and assumes no obligation and expressly disclaims any duty to update any forward-looking statement to reflect events or circumstances after the date of this news release or to reflect the occurrence of subsequent events.

Contacts
MultiCell Technologies, Inc.
Dr. Stephen Chang, CEO
MCETInvestor@MultiCelltech.com
or
Trilogy Capital Partners (Financial Communications)
Paul Karon, 800-592-6067
paul@trilogy-capital.com

Final Results For ReceptoPharm's RPI-78M In Multiple Sclerosis Animal Model, Nutra Pharma

Nutra Pharma Corp, (OTCBB:NPHC) a biotechnology holding company that owns rights to intellectual property related to the development of drugs for HIV and Multiple Sclerosis has announced the completion of studies using RPI-78M in an animal model of Multiple Sclerosis (MS). RPI-78M is the lead drug candidate of Nutra Pharma's holding, ReceptoPharm, Inc. and is being studied in preclinical assays for its efficacy in treating MS.

EAE (experimental allergic encephalomyelitis) is the standard benchmark animal methodology for the study of MS. ReceptoPharm's drug, RPI-78M, proved to be very effective in preventing the onset of disability in acute and chronic models of the disease. The drug was also very effective in preventing the infiltration of immune cells into the central nervous system. This research was conducted to confirm the reported benefits of similar products in immune mediated diseases such as Multiple Sclerosis and Rheumatoid Arthritis.

"The EAE study yielded the results we expected though we were pleasantly surprised at the reduced CNS infiltration by lymphocytes," commented Paul Reid, PhD, CEO of ReceptoPharm. "The results of this study complete the rationale for entering into clinical trials for the MS indication. We are actively working on one IND for the Phase II/III AMN (Adrenomyeloneuropathy) indication and when that is completed we will be in a good position to enter into MS trials," he added.

The study was conducted by researchers in the Department of Anatomy and Cell Biology at the University of Saskatchewan. The lead researcher, Associate Professor Dr. Adel Mohamed, reported that the preliminary results indicate that RPI-78M inhibited the development of acute as well as the relapsing phases of the EAE in Lewis rats. The report also stated that, if confirmed, these preliminary results suggest that it is of interest to initiate clinical trials on MS patients using the drug. The conclusion of the report stated that it seems within the realm of possibility that RPI-78M may be as, if not more, therapeutically efficacious as the current interferon drugs in the treatment of neurologic disease.

"These results are very encouraging," commented Rik Deitsch, CEO of Nutra Pharma. "The positive results of the animal model as well as the strong findings from the microarray analysis support our move into Phase II human clinical trials," he added.

The final results of the EAE study are being submitted for journal publication and for presentation within the scientific community.

About Nutra Pharma Corp

Nutra Pharma Corp. is a biopharmaceutical company specializing in the acquisition, licensing and commercialization of pharmaceutical products and technologies for the management of neurological disorders, cancer, autoimmune and infectious diseases. Nutra Pharma Corp. through its subsidiaries carries out basic drug discovery research and clinical development and also seeks strategic licensing partnerships to reduce the risks associated with the drug development process. The Company's holding, ReceptoPharm, Inc, is developing technologies for the development of drugs for HIV and Multiple Sclerosis ("MS"). The Company's other holding Nanologix, Inc., is engaged in the research and development of diagnostic test kits designed to be used for the rapid identification of infectious diseases such as Tuberculosis (TB) and Mycobacterium avium-intracellulare (MAI). Nutra Pharma continues to identify and acquire intellectual property and companies in the biotechnology arena. http://www.nutrapharma.com.

About ReceptoPharm, Inc.

ReceptoPharm is a bio-pharmaceutical company developing proprietary therapeutic proteins for the treatment of several chronic, life-threatening viral, auto-immune and neuro-degenerative disorders, specifically including Rabies, HIV, and Myasthenia gravis (MG). http://www.receptopharm.com.

This press release contains forward-looking statements. The words or phrases "would be," "will allow," "intends to," "will likely result," "are expected to," "will continue," "is anticipated," "estimate," "project," or similar expressions are intended to identify "forward-looking statements." Actual results could differ materially from those projected in Nutra Pharma's ("the Company") business plan. The Company's business is subject to various risks, which are discussed in the Company's filings with the Securities and Exchange Commission ("SEC"). The information presented should not be construed as an indication in any way whatsoever of the value of the Company or its common stock. The Company's filings may be accessed at the SEC's Edgar system at www.sec.gov. Statements made herein are as of the date of this press release and should not be relied upon as of any subsequent date. The Company cautions readers not to place reliance on such statements. Unless otherwise required by applicable law, we do not undertake, and we specifically disclaim any obligation, to update any forward-looking statements to reflect occurrences, developments, unanticipated events or circumstances after the date of such statement.

http://www.nutrapharma.com

MS man's stem cell treatment hope

Mr Cooper said he is willing to risk the treatment

A multiple sclerosis sufferer has been warned he is risking his health after deciding to fly to Holland to undergo controversial stem cell therapy. Kevin Cooper, 47, from Crook, County Durham, was diagnosed 13 years ago and says he has nothing to lose.

But some health professionals claim there is no proof stem cell treatment can help, and that Mr Cooper is putting himself at risk.

His friends have helped raise thousands of pounds for the treatment.

Mr Cooper flies to the clinic in Rotterdam on Tuesday for the treatment, which involves the cells being injected into his body.

Stem cells have the potential to turn into many different types of cell that make up tissues and organs, which is why experts have heralded their promise for treating a variety of genetic diseases.

But Colin McGuckin, Professor of Regenerative Medicine at Newcastle University warned the treatment might not be the answer for Mr Cooper.

"Stem cells, although they hold great promise for the future, have not actually been proven to help in the treatment of MS," he said.

"We do not believe it is right for people to go to another country where they could put their lives at risk for an untried treatment which would not be allowed on the NHS."

But Mr Cooper said the disease has wrecked his life and he is willing to risk the treatment.

He said: "I worked all over the world, fixing equipment and I loved my job. Now I couldn't even climb up the stairs let alone climb on a machine to repair it.

"They have their opinion, but they haven't got MS. I've got MS and I'm struggling. I'm too young to sit back in the house and just look out the window."

Mr Cooper returns home on Thursday and says he hopes to see an improvement in his condition within six months.

Health Canada Grants Approval of TYSABRI(TM) (natalizumab) for the Treatment of Multiple Sclerosis Following Priority Review

4 October 2006



First New Class of Treatment in Ten Years Shown to Reduce Rate of Relapses by 68%(1)

MISSISSAUGA, Ontario & DUBLIN, Ireland, Oct 04, 2006 (BUSINESS WIRE) -- Biogen Idec Canada and Elan Corporation, plc announced today that following a priority review process, Health Canada has granted approval to TYSABRI(TM) (natalizumab) for the treatment of relapsing-remitting multiple sclerosis (MS).(2) TYSABRI is the first in a new therapeutic class of MS treatments (called selective adhesion molecule inhibitors) and has been shown to significantly reduce the rate of MS relapses as well as the progression of disability associated with the illness.(2)

"TYSABRI has demonstrated a major reduction in relapses - by more than two-thirds - in clinical trials," said Dr. Paul O'Connor, AFFIRM Principal Investigator and Chief of Division of Neurology, St Michael's Hospital, Toronto. "Clinical trials that have looked at TYSABRI provide us with impressive evidence that it is a highly effective treatment for patients with MS."

A two-year, randomized, multi-centre, placebo-controlled, double-blind study (called AFFIRM) enrolled 942 patients and evaluated the effect of TYSABRI on the rate of clinical relapses and the progression of disability.(3) The results found that TYSABRI reduced the rate of clinical relapses by 68 per cent relative to placebo (p less than 0.001), and the risk of sustained disability progression associated with MS by 42 per cent relative to placebo (p less than 0.001).(4) Treatment with TYSABRI also resulted in sustained and statistically significant reductions in brain lesion activity as measured by magnetic resonance imaging (MRI) scans.(4)

In Canada, TYSABRI is indicated as monotherapy (i.e. single disease-modifying agent for the treatment of patients with the relapsing-remitting form of MS to reduce the frequency of clinical relapses, to delay the progression of disability and to decrease the number and volume of active brain lesions identified on magnetic resonance imaging (MRI) scans.(4) TYSABRI is administered once every four weeks by intravenous infusion.(5)

"TYSABRI's administration every four weeks also offers an additional benefit compared to the currently available MS therapies, some of which are injected as often as daily," said O'Connor.

MS attacks the protective myelin covering of the central nervous system, causing inflammation and often destroying the myelin in patches. In its most common form, relapsing-remitting MS, the illness is characterized as having well defined attacks followed by complete or partial recovery.(6) Relapsing-remitting MS makes up 75% of all MS cases in Canada.(7)

TYSABRI works by preventing the body's affected immune cells from migrating from the bloodstream into the brain where they can cause inflammation and potentially damage nerve fibers and their insulation.(8)

"Canada has one of the highest rates of MS in the world.(9) The approval of TYSABRI represents an important step forward for Canadians living with this disease," said Deanna Groetzinger, vice president of government relations and policy at the Multiple Sclerosis Society of Canada. "We are pleased there is another approved treatment option for Canadians with relapsing-remitting MS."

Paulette O'Leary, 36, has been living with MS for over half of her life. At one point a relapse left her without the use of her legs and numbness across the left side of her body. After other therapy options failed to help her, O'Leary opted to travel to the United States to receive TYSABRI treatments when it was approved by the Food and Drug Administration (FDA) in the US.

"My particular experience with MS was really terrible. The illness hit me very hard, and I went from my normal, everyday life, to feeling awful physically and emotionally. After one relapse I was left in a wheelchair," said O'Leary. "I eventually recovered, but did not escape some permanent residual disability. I tried several other therapies, but when I was on TYSABRI the results were quite impressive. For the first time in a long time, I could walk, I could do the things that I love to do - I could actually live my life again."

Independent safety evaluation published

Biogen Idec and Elan Corporation, plc voluntarily suspended TYSABRI from the US market and from all clinical trials in 2005. This was based on three cases of progressive multifocal leukoencephalopathy (PML).

A comprehensive, independent safety evaluation of more than 3,000 patients treated with TYSABRI was completed.

The detailed safety analysis of the data yielded no new confirmed cases of PML beyond the three previously reported. The results of this safety evaluation were published in the March 2006 issue of the New England Journal of Medicine.(10)

"The safety data analysis that was carried by an independent panel of experts is reassuring. And getting an understanding of the benefit-risk profile of TYSABRI is an important step towards bringing this medicine to Canadian MS patients with confidence," said Dr. O'Connor. "Any treatment decision should carefully evaluated by patients and their physicians."

Patients who are prescribed TYSABRI should enroll in the TYSABRI Care Program. The program ensures that appropriate physicians and infusion centres are able to prescribe or infuse the product.(11) The TYSABRI Care Program is a comprehensive program that will support the safe and effective use of TYSABRI by physicians and patients on an ongoing basis. It will optimize treatment through improved compliance, will standardize infusion treatment at clinics, will support safety through rigorous education and on-going surveillance, and, through support in areas like reimbursement and patient support, will ease the administrative burden of physicians and patients, allowing patients and their treatment team to focus on treating the illness.

AFFIRM and SENTINEL Phase III study design and adverse events

AFFIRM is a two-year, randomized, multi-center, placebo-controlled, double-blind study of 942 patients conducted in 99 sites worldwide (including ten sites in Canada with 101 MS patients), evaluating the effect of TYSABRI on the progression of disability as measured by at least a one-point increase on the Expanded Disability Status Scale (EDSS) sustained for three months, and the rate of clinical relapses. Progression of disability is a sustained change that has a long-term impact on a patient's functional and ambulatory performance. Patients in AFFIRM were randomized to receive either a 300 mg IV infusion dose of TYSABRI (n=627) or placebo (n=315) every four weeks.(4)

SENTINEL is a two-year, randomized, multi-center, placebo-controlled, double-blind study of 1,171 AVONEX(R)-treated patients in 123 clinical trial sites worldwide. AVONEX-treated patients who continued to experience disease activity were randomized to add TYSABRI (n=589) or placebo (n=582) to their standard regimen.(12)

The two-year adverse event profile in AFFIRM and SENTINEL were consistent with previously reported one-year results. Common events included headache, fatigue, urinary tract infection, depression, lower respiratory tract infection, limb and joint pain, and pharyngitis.(4), (12) The rate and incidence of infections in patients treated with TYSABRI and placebo-treated patients were similar. Serious infections occurred in 3.2 percent and 2.6 percent of patients treated with TYSABRI and placebo-treated patients, respectively.

Use of TYSABRI has been associated with an increased risk of progressive multifocal leukoencephalopathy (PML). PML can cause severe disability or death.(13)

Cases of PML included patients who were treated with TYSABRI for over two years or who received intermittent doses of TYSABRI over an 18-month period. In clinical trials, two cases of PML were observed in 1869 patients with multiple sclerosis treated for a median of 120 weeks; the third case occurred among 1043 patients with Crohn's disease after the patient received 8 doses. These patients were concomitantly exposed to immunomodulators (e.g. interferon beta) or were immunocompromised due to treatment with immunosuppressants (e.g. azathioprine).(14)

TYSABRI has also been associated with hypersensitivity reactions, including serious systemic reactions that occurred at an incidence of less than 1 percent of patients.(14)

About Multiple Sclerosis

Multiple sclerosis (MS) is a chronic, unpredictable and potentially disabling disease of the central nervous system that affects approximately 55,000-75,000 Canadians.(11) Canada has one of the highest rates of MS in the world - it is estimated that three Canadians are newly diagnosed with MS every day.(10), (11) It is known as a disease of young adults, with onset, usually in women, between the ages of 15 and 40. It is characterized by symptoms such as vision problems, loss of balance, numbness, difficulty walking and even complete paralysis.(7)

About Biogen Idec

Biogen Idec (NASDAQ: BIIB) creates new standards of care in oncology, neurology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare. For press releases and additional information about the company, please visit www.biogenidec.com.

About Elan

Elan Corporation, plc (NYSE: ELN) is a neuroscience-based biotechnology company committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world. Elan shares trade on the New York, London and Dublin Stock Exchanges. For additional information about the company, please visit www.elan.com.

ATTENTION TELEVISION ASSIGNMENT/PRODUCERS:

B-roll available via satellite:
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(1) TYSABRI Product Monograph 2006, page 18

(2) TYSABRI Product Monograph 2006, page 3

(3) Polman, Chris H. et al. The New England Journal of Medicine. 2006; 354: 899-910.

(4) TYSABRI Product Monograph 2006, page 3

(5) TYSABRI Product Monograph 2006, page 12

(6) Multiple Sclerosis Society of Canada website, http://www.mssociety.ca/en/information/faq.htm#2 accessed September 21, 2006.

(7) http://www.mssociety.ca/en/information/types.htm, accessed on September 21, 2006.

(8) TYSABRI Product Monograph, page 13-14

(9) Multiple Sclerosis Society of Canada Medical Update Memo, May 2, 2006

(10) Yousry, Tarek A. et al. The New England Journal of Medicine. 2006: 354: 924-933.

(11) Tysabri Product Monograph 2006, page 4

(12) Rudick, Richard A. et al. The New England Journal of Medicine. 2006; 354: 911-923.

(13) TYSABRI Product Monograph 2006, page 5

(14) TYSABRI Product Monograph 2006, page 7

SOURCE: Elan Corporation, plc

Hill & Knowlton Canada
Peter Gay, 416-413-4732
Cell: 416-523-1420
peter.gay@hillandknowlton.ca or
Farah Meghji, 416-413-4737
Cell: 416-894-3174
farah.meghji@hillandknowlton.ca



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UCB and Biogen Idec to Collaborate on Oral Multiple Sclerosis Therapy

Companies to Co-Develop and Co-Commercialize Small Molecule Compound Being Studied for the Treatment of Relapsing-Remitting Multiple Sclerosis

Brussels (Belgium) and Cambridge, MA (USA) - October 2, 2006 - 10:01 pm CET / 4:01 pm EST - UCB (Euronext Brussels: UCB) and Biogen Idec (NASDAQ: BIIB) today announced a global collaboration to jointly develop and commercialize CDP323 for the treatment of relapsing-remitting multiple sclerosis (MS) and other potential indications. CDP323 is an orally active small molecule a4-integrin inhibitor expected to enter Phase II clinical trials next year.

Under terms of the agreement, UCB will receive upfront and additional payments for development and commercial milestones in excess of 200 million US dollars. Furthermore Biogen Idec will contribute significantly to clinical costs for Phase II and Phase III studies. All commercialization costs and profits will be shared equally.

"Multiple Sclerosis affects more than a million people worldwide and we are delighted to be collaborating with Biogen Idec on our exciting CDP323 program. CDP323 has arisen from UCB's in-depth understanding of integrin biology and chemistry to address this difficult protein target. Our outstanding Phase I results encourage us to move rapidly into Phase II trials in MS patients. We believe that if trials are successful CDP323 could make a real difference for MS patients with this severe and debilitating disease," stated Melanie Lee, Executive Vice President, Research & Development for UCB.

"We are always looking to enhance and expand our arsenal in the fight against MS," said Al Sandrock, Senior Vice President, Neurology Research and Development for Biogen Idec. "Another effective oral therapy would augment Biogen Idec's broad portfolio of products and potential therapies in development for this debilitating disease. We are pleased that UCB has decided to partner with us on such a promising program."

About CDP323
CDP323 is a potent and orally active small molecule prodrug antagonist of a4-integrins. The safety, tolerability and pharmacokinetic profile of CDP323 have been evaluated in healthy volunteers in three separate Phase I studies. CDP323 was well tolerated with an adverse event profile comparable to placebo. Data from these studies have been reported at the 2006 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

About Multiple Sclerosis
MS is a chronic disease of the central nervous system that affects approximately 400,000 people in North America and more than one million people worldwide. It is a disease that affects more women than men, with onset typically occurring between 20 and 50 years of age. MS is caused by damage to myelin, the protective sheath surrounding nerve fibers in the central nervous system, which interferes with messages from the brain to the body. Symptoms of MS may include vision problems, loss of balance, numbness, difficulty walking and paralysis.

About UCB
UCB (www.ucb-group.com) is a leading global biopharmaceutical company dedicated to the research, development and commercialisation of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders, allergy/respiratory diseases, immune and inflammatory disorders and oncology. UCB focuses on securing a leading position in severe disease categories. Employing over 8,300 people in over 40 countries, UCB achieved revenue of 2.3 billion euro in 2005. UCB is listed on the Euronext Brussels Exchange and its worldwide headquarters are located in Brussels, Belgium.

About Biogen Idec
Biogen Idec creates new standards of care in oncology, neurology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare. For press releases and additional information about the company, please visit www.biogenidec.com.

UCB and Biogen Idec Safe Harbor
This press release contains forward-looking statements regarding the agreement with UCB and the development of CDP323. Drug development involves a high degree of risk. Only a small number of research and development programs result in commercialization of a product. Factors which could cause actual results to differ materially from Biogen Idec's current expectations include the risk that the company may not be able to demonstrate the safety and efficacy of CDP323 at each stage of the clinical trial process; technical hurdles relating to the manufacture of CDP323 may be encountered; the company may not be able to meet applicable regulatory standards or regulatory authorities may fail to approve CDP323; and the company may encounter other unexpected hurdles. For more detailed information on the risks and uncertainties associated with Biogen Idec's drug development activities, see the section entitled "Risk Factors" in Biogen Idec's quarterly report on Form 10-Q for the fiscal quarter ended June 30, 2006 that was filed with the Securities and Exchange Commission, as well as other periodic and current reports of Biogen Idec filed with the Securities and Exchange Commission. Biogen Idec assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.


For more information contact:

UCB
Jean-Christophe Donck
Vice President, Corporate Communications and Investor Relations
Tel. +32 2 559 9346
jc.donck@ucb-group.com

Mareike Mohr
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COPAXONE(R) Showed Sustained Benefit on Slowing Brain Tissue Damage in Multiple Sclerosis Patients

Oct 2 2006, 8:00 AM EST

BIOWIRE


Data presented last week at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Madrid, Spain, showed that COPAXONE(R) (glatiramer acetate injection) may slow the neurodegenerative tissue damage that is a key aspect of multiple sclerosis (MS) disease pathology. Results of the longest, prospective study of annual brain proton MRS imaging in relapsing-remitting multiple sclerosis (RRMS) patients suggested a beneficial effect of COPAXONE(R) treatment on cerebral axonal injury and recovery.

"These data reinforce the findings of previous studies showing that in addition to reducing relapses in RRMS patients over the long term, COPAXONE(R) may have the unique ability to slow or prevent neurodegenerative processes by reducing axonal injury and promoting axonal recovery within the central nervous system, and that this benefit is sustained over time," said Omar Khan, M.D., Wayne State University and lead investigator of the study.

In MS, measuring brain n-acetylaspartate (NAA) levels relative to creatine (Cr) (NAA/Cr ratios) via MRS is a method of assessing axonal injury caused by the disease. Decreased levels of brain NAA/Cr ratios are a marker of neuronal damage or degeneration and also correlate strongly to clinical disability; an increase in brain NAA/Cr ratios indicates a recovery of injured nerve cells or neurons in the brain. This study involved annual blinded MRS analyses of NAA/Cr of patients (n=22), over four years.

"Patients in this study who remained on COPAXONE(R) (glatiramer acetate injection) experienced an increase in mean NAA/Cr, pointing not only to the treatment's effect on slowing accumulation of brain tissue damage as measured by MRS, but to its effect on the recovery of damaged brain tissue," said Khan. "Measuring changes in NAA/Cr ratio throughout the course of the disease is of increasing interest to the MS research community because of data demonstrating its correlation with accumulated disability, pointing to the potential for MRS imaging to serve as a surrogate marker for both disease progression and therapeutic response in clinical practice."

About the Study

In this study, investigators performed annual conventional magnetic resonance imaging (MRI) as well as MRS measurements on treatment-naive RRMS patients (n=22), 18 of whom commenced treatment with COPAXONE(R) and four who remained untreated by choice. Over the four years of the study, blinded annual MRS analyses of NAA/Cr were carried out in a volume-of-interest (VOI) centered on the entire corpus callosum, which also allowed for the examination of the normal appearing white matter (NAWM) within the corpus callosum. At baseline, patients' (n=18) mean NAA/Cr ratios (+/-SD) for the entire VOI was 1.97 (+/- 0.24) and was 2.075 (+/- 0.30) in the NAWM. After four years of follow up, 15 of the 18 patients in the treated group were still receiving COPAXONE(R) and demonstrated an increase to a mean NAA/Cr of 2.21 (+/- 0.16) in the VOI and 2.27 (+/- 0.20) in the NAWM.

Companies to Co-Develop and Co-Commercialize Small Molecule Compound Being Studied for the Treatment of Relapsing-Remitting Multiple Sclerosis

Brussels (Belgium) and Cambridge, MA (USA) - October 2, 2006 - 10:01 pm CET / 4:01 pm EST - UCB (Euronext Brussels: UCB) and Biogen Idec (NASDAQ: BIIB) today announced a global collaboration to jointly develop and commercialize CDP323 for the treatment of relapsing-remitting multiple sclerosis (MS) and other potential indications. CDP323 is an orally active small molecule alpha4-integrin inhibitor expected to enter Phase II clinical trials next year.

Under terms of the agreement, UCB will receive upfront and additional payments for development and commercial milestones in excess of 200 million US dollars. Furthermore Biogen Idec will contribute significantly to clinical costs for Phase II and Phase III studies. All commercialization costs and profits will be shared equally.

"Multiple Sclerosis affects more than a million people worldwide and we are delighted to be collaborating with Biogen Idec on our exciting CDP323 program. CDP323 has arisen from UCB's in-depth understanding of integrin biology and chemistry to address this difficult protein target. Our outstanding Phase I results encourage us to move rapidly into Phase II trials in MS patients. We believe that if trials are successful CDP323 could make a real difference for MS patients with this severe and debilitating disease," stated Melanie Lee, Executive Vice President, Research & Development for UCB.

"We are always looking to enhance and expand our arsenal in the fight against MS," said Al Sandrock, Senior Vice President, Neurology Research and Development for Biogen Idec. "Another effective oral therapy would augment Biogen Idec's broad portfolio of products and potential therapies in development for this debilitating disease. We are pleased that UCB has decided to partner with us on such a promising program."

About CDP323

CDP323 is a potent and orally active small molecule prodrug antagonist of alpha4-integrins. The safety, tolerability and pharmacokinetic profile of CDP323 have been evaluated in healthy volunteers in three separate Phase I studies. CDP323 was well tolerated with an adverse event profile comparable to placebo. Data from these studies have been reported at the 2006 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

About Multiple Sclerosis

MS is a chronic disease of the central nervous system that affects approximately 400,000 people in North America and more than one million people worldwide. It is a disease that affects more women than men, with onset typically occurring between 20 and 50 years of age. MS is caused by damage to myelin, the protective sheath surrounding nerve fibers in the central nervous system, which interferes with messages from the brain to the body. Symptoms of MS may include vision problems, loss of balance, numbness, difficulty walking and paralysis.

About UCB

UCB (www.ucb-group.com) is a leading global biopharmaceutical company dedicated to the research, development and commercialisation of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders, allergy/respiratory diseases, immune and inflammatory disorders and oncology. UCB focuses on securing a leading position in severe disease categories. Employing over 8,300 people in over 40 countries, UCB achieved revenue of 2.3 billion euro in 2005. UCB is listed on the Euronext Brussels Exchange and its worldwide headquarters are located in Brussels, Belgium.

About Biogen Idec

Biogen Idec creates new standards of care in oncology, neurology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare. For press releases and additional information about the company, please visit www.biogenidec.com.

UCB and Biogen Idec Safe Harbor

This press release contains forward-looking statements regarding the agreement with UCB and the development of CDP323. Drug development involves a high degree of risk. Only a small number of research and development programs result in commercialization of a product. Factors which could cause actual results to differ materially from Biogen Idec's current expectations include the risk that the company may not be able to demonstrate the safety and efficacy of CDP323 at each stage of the clinical trial process; technical hurdles relating to the manufacture of CDP323 may be encountered; the company may not be able to meet applicable regulatory standards or regulatory authorities may fail to approve CDP323; and the company may encounter other unexpected hurdles. For more detailed information on the risks and uncertainties associated with Biogen Idec's drug development activities, see the section entitled "Risk Factors" in Biogen Idec's quarterly report on Form 10-Q for the fiscal quarter ended June 30, 2006 that was filed with the Securities and Exchange Commission, as well as other periodic and current reports of Biogen Idec filed with the Securities and Exchange Commission. Biogen Idec assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Twin genes do battle over multiple sclerosis

Press releases 2006 : 27 Sep: Genes & MS

Scientists have found that a risk gene for multiple sclerosis (MS) is fought by a twin gene which tries to dampen the effects of the disease.

The gene that puts a person a risk of MS - DR2b – is always found with its partner, DR2a. This protective twin masks the risk gene’s negative effect by redirecting the immune system to prevent it from attacking the body. Overall this fight reduces the severity of MS symptoms.

The research, published in Nature, also reveals that positive natural selection is at work, because DR2b is never passed on without the modifying gene DR2a. Positive selection means that the genes are inherited together, not by chance but because their pairing gives an advantage.

One of the lead researchers, Professor Lars Fugger, a clinical immunologist based in the Medical Research Council Human Immunology Unit explains: ‘Multiple Sclerosis is an autoimmune disease, in other words, it is caused by the immune system attacking the body. The DR2b gene clearly tells the immune system to go hard into battle against the body’s own tissue, so it starts to work in a way that actually damages the person. For this reason, natural selection has eliminated the gene on its own, but allowed it to be inherited only when it is accompanied by another gene [DR2a] which tempers its effect.’

Using mice bred to carry different combinations of DR2b and DR2a, the researchers made it possible to observe how the two genes interact to affect severity of MS symptoms.

They found that the mice engineered to carry only the DR2b had a severe form of MS that is seen in a minority of human MS patients. The mice with both genes, however, were less likely to get MS in the first place and had a less severe form of MS if they did, this resembles the most common form of MS in humans. In some cases, these mice spontaneously recovered. The researchers concluded that DR2b was the MS ‘culprit’ and DR2a cancelled out some of its effects.

As well as evidence that there is interaction between the two genes, whereby DR2a influences DR2b, the research also revealed the role of each gene in predisposition to MS.

Further analysis revealed each gene’s precise influence over the immune system and thus their respective roles in causing and abating MS symptoms.

The researchers are hopeful that exploiting DR2a’s control mechanism could be a way to treat MS symptoms in the future.

Professor Fugger said: 'This is a new way to assess how genes contribute to autoimmune diseases overall. Thus, this study is not only relevant to understand how genes interact in MS, but also in diabetes, rheumatoid arthritis and psoriasis which are all autoimmune diseases'

For further information or to arrange an interview with Dr Fugger please contact the MRC Press Office on 0207 637 6011, press.office@headoffice.mrc.ac.uk or out of hours on 07818 428 297.

Notes to Editors

1.Functional epistasis on a common MHC haplotype associated with multiple sclerosis is published online in Nature on 27th September 2006.

2.Around 85,000 people in the UK have Multiple Sclerosis. MS is the result of damage to myelin, a protective sheath surrounding nerve fibres of the central nervous system, due to myelin being attacked by the immune system. When myelin is damaged, messages between the brain and other parts of the body are inhibited. MS is a lifelong condition with a wide range of symptoms including pain, muscle problems, impaired cognitive function, and impaired vision.

3.The precise cause of MS is not known and many factors, both environmental and genetic, are understood to be involved. Around two-thirds of MS sufferers have the DR2 pair of genes. Having the DR2 pair of genes does not automatically mean an individual will have MS.

4.The Medical Research Council (MRC) is funded by the UK tax-payer. It aims to improve human health. The research it supports and the scientists it trains meet the needs of the health services, the pharmaceutical and other health-related industries and universities. The MRC has funded work which has led to some of the most significant discoveries and achievements in medicine in the UK. http://www.mrc.ac.uk

5.The Wellcome Trust also supported part of this research: The Wellcome Trust is the most diverse biomedical research charity in the world, spending about £450 million every year both in the UK and internationally to support and promote research that will improve the health of humans and animals. The Trust was established under the will of Sir Henry Wellcome, and is funded from a private endowment, which is managed with long-term stability and growth in mind.


©2006 Medical Research Council

COPAXONE(R) Showed Sustained Benefit on Slowing Brain Tissue Damage in Multiple Sclerosis Patients

Monday October 2, 8:00 am ET

New Data from the Longest Prospective Study Employing Annual Magnetic Resonance Spectroscopy Imaging (MRS) Indicate Impact of COPAXONE(R) on Axonal Injury and Recovery

KANSAS CITY, Mo.--(BUSINESS WIRE)--Data presented last week at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Madrid, Spain, showed that COPAXONE® (glatiramer acetate injection) may slow the neurodegenerative tissue damage that is a key aspect of multiple sclerosis (MS) disease pathology. Results of the longest, prospective study of annual brain proton MRS imaging in relapsing-remitting multiple sclerosis (RRMS) patients suggested a beneficial effect of COPAXONE® treatment on cerebral axonal injury and recovery.
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"These data reinforce the findings of previous studies showing that in addition to reducing relapses in RRMS patients over the long term, COPAXONE® may have the unique ability to slow or prevent neurodegenerative processes by reducing axonal injury and promoting axonal recovery within the central nervous system, and that this benefit is sustained over time," said Omar Khan, M.D., Wayne State University and lead investigator of the study.

In MS, measuring brain n-acetylaspartate (NAA) levels relative to creatine (Cr) (NAA/Cr ratios) via MRS is a method of assessing axonal injury caused by the disease. Decreased levels of brain NAA/Cr ratios are a marker of neuronal damage or degeneration and also correlate strongly to clinical disability; an increase in brain NAA/Cr ratios indicates a recovery of injured nerve cells or neurons in the brain. This study involved annual blinded MRS analyses of NAA/Cr of patients (n=22), over four years.

"Patients in this study who remained on COPAXONE® (glatiramer acetate injection) experienced an increase in mean NAA/Cr, pointing not only to the treatment's effect on slowing accumulation of brain tissue damage as measured by MRS, but to its effect on the recovery of damaged brain tissue," said Khan. "Measuring changes in NAA/Cr ratio throughout the course of the disease is of increasing interest to the MS research community because of data demonstrating its correlation with accumulated disability, pointing to the potential for MRS imaging to serve as a surrogate marker for both disease progression and therapeutic response in clinical practice."

About the Study

In this study, investigators performed annual conventional magnetic resonance imaging (MRI) as well as MRS measurements on treatment-naive RRMS patients (n=22), 18 of whom commenced treatment with COPAXONE® and four who remained untreated by choice. Over the four years of the study, blinded annual MRS analyses of NAA/Cr were carried out in a volume-of-interest (VOI) centered on the entire corpus callosum, which also allowed for the examination of the normal appearing white matter (NAWM) within the corpus callosum. At baseline, patients' (n=18) mean NAA/Cr ratios (+/-SD) for the entire VOI was 1.97 (+/- 0.24) and was 2.075 (+/- 0.30) in the NAWM. After four years of follow up, 15 of the 18 patients in the treated group were still receiving COPAXONE® and demonstrated an increase to a mean NAA/Cr of 2.21 (+/- 0.16) in the VOI and 2.27 (+/- 0.20) in the NAWM.

About COPAXONE®

Current data suggest COPAXONE® (glatiramer acetate injection) is a selective MHC class II modulator. COPAXONE® is indicated for the reduction of the frequency of relapses in RRMS. The most common side effects of COPAXONE® are redness, pain, swelling, itching, or a lump or an indentation at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.

COPAXONE® is now approved in 44 countries worldwide, including the United States, Canada, Mexico, Australia, Israel, and all European countries. In Europe, COPAXONE® is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. In North America, COPAXONE® is marketed by Teva Neuroscience, Inc.

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80 percent of Teva's sales are in North America and Europe.

See additional important information at http://www.copaxone.com/pi/index.html or call 1-800-887-8100 for electronic releases. For hardcopy releases, please see enclosed full prescribing information.

Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management's current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause Teva`s future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements.

Important factors that could cause or contribute to such differences include risks relating to Teva's ability to rapidly integrate Ivax Corporation's operations and achieve expected synergies, Teva`s ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic products, the impact of competition from brand-name companies that sell or license their own brand products under generic trade dress and at generic prices (so called "authorized generics") or seek to delay the introduction of generic product, the impact of consolidation of our distributors and customers, regulatory changes that may prevent Teva from exploiting exclusivity periods, potential liability for sales of generic products prior to a final resolution of outstanding litigation, including that relating to the generic versions of Allegra®, Neurontin®, Oxycontin® and Zithromax®, the effects of competition on Copaxone® sales, including as a result of the reintroduction of Tysabri® into the market, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, the regulatory environment and changes in the health policies and structures of various countries, Teva's ability to successfully identify, consummate and integrate acquisitions, potential exposure to product liability claims, dependence on patent and other protections for innovative products, significant operations worldwide that may be adversely affected by terrorism or major hostilities, environmental risks, fluctuations in currency, exchange and interest rates, operating results and other factors that are discussed in Teva's Annual Report on Form 20-F and its other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.


Contact:
Teva Neuroscience
John Shaw, 816-508-5062
john.shaw@tevaneuro.com
Source: Teva Pharmaceutical Industries Ltd.