Lawsuit looms for Parexel over drug trial disaster

By Kirsty Barnes

13/03/2007 - Legal action could begin today against Parexel if the firm does not come up with "an adequate proposal" to compensate the victims of last years drug trial disaster in Northwick Park, London.

Lawyers representing four of the six injured men are poised to begin immediate legal proceedings if last minute talks being held today with the US-owned contract research organisation (CRO) fail.

Parexel was at the centre of the drug trial disaster last year after six out of eight men it carried out Phase I trials on - under contract on behalf of small German biotech firm TeGenero - experienced a severe and systemic adverse reaction and were admitted to intensive care with hours of taking the experimental drug.

The drug behind the fury is called TGN1412, a monoclonal antibody (mAb) that was being developed by TeGenero to treat conditions including multiple sclerosis, rheumatoid arthritis and leukaemia.

TeGenero has since gone bust and Parexel has been left to weather the ensuing storm.

How it is weathering it though, remains questionable, according to Gene Matthews, a solicitor from Leigh Day & Co solicitors - the London law firm representing four of the victims.

"Their response to us to date, and to the media for that matter, has been total silence," Matthews told Outsourcing-Pharma.com.

"Our clients got sick of waiting for Parexel to acknowledge them and so have now instructed us to commence legal proceedings. Only now after hearing this - one year after the event - have Parexel's lawyers agreed to sit down and talk with us to see if we can come up with some kind of compensation settlement."

According to Matthews, although Parexel was cleared of any blame in a subsequent UK Medicines and Healthcare products Regulatory Agency (MHRA) investigation, the CRO still has a case to answer for its role in the debacle.

"There are a number of issues surrounding the trial itself and the handling of the situation following the adverse reactions that we find questionable," he said.

Firstly there are questions over Parexel's involvement in the design of the trial.

"We don't know the extent of their involvement in the trial design yet but it is very likely that TeGenero - being a small German firm - relied on Parexel - a large international firm - for getting the protocol approved by the regulatory bodies and ethics committees," said Matthews.

Secondly, the issue of drug dosing is being scrutinised by the victims' lawyers.

"According to documents we have, the subjects were administered the trial drug at five- to eight-minute intervals. It is our understanding after speaking to a clinical immunologist and another industry expert that this was against good clinical practice (GCP) for this type of drug," said Matthews.

"They said that when testing a mAb for the first time, extra caution should be taken, including allowing sufficient time to wait for and deal with any sideeffects that may arise."

Thirdly, the lawyers believe that the way that Parexel staff dealt with the drug reactions was inadequate.

"It clearly states in the regulatory documents submitted by Parexel that cytokine release syndrome (which the six subjects suffered) was a possible consequence of the drug being tested," said Matthews.

The investigator's brochure also states that in the event of such a reaction, appropriate counter-measures - of which the application of high dose glucocorticoids or anti-histamines was suggested - must be taken, he said.

"However, the subjects did not receive high dose steroids until they were administered by the National Health Service (NHS) in intensive care 16-18 hours later," said Matthews.

"Our industry expert said that this delay in treatment worsened the health outcomes of our clients."

On the same subject, Matthews believes that Parexel should have informed the Northwick Park hospital of the type of drug it was testing before the trials started.

"The treating physicians at the hospital were in the dark - they had no idea what they were dealing with and this lad to delays in treatment."

"Our expert said testing on a drug of this type has a very high risk of a cytokine release syndrome reaction, and the hospital should have been forewarned so they could be prepared for a rapid response in the event of an emergency," said Matthews.

Parexel was asked by Outsourcing-Pharma.com to comment but failed to do so.

Avigen Receives Approval to Initiate AV650 Phase II Clinical Development

Avigen to Present at Cowen and Company Annual Health Care Conference

Webcast Scheduled for 9:30 a.m. (ET) on Thursday, March 15, 2007

ALAMEDA, Calif., March 14, 2007 (PRIME NEWSWIRE) -- Avigen, Inc. (Nasdaq:AVGN) a biopharmaceutical company developing innovative therapies for the treatment of neurological conditions, today announced it was given approval from the U.S. Food and Drug Administration to commence Phase II clinical development of AV650 (tolperisone). AV650 is a New Chemical Entity (NCE) in the United States. Tolperisone is approved in several EU member countries for the treatment of spasticity and muscle spasms. Avigen's initial Phase II trial will assess the safety, tolerability, and initial efficacy, as well as AV650's lack of sedation, in spinal cord injury patients suffering from spasticity. This study will be a multi-center, double-blind, placebo-controlled trial and will explore doses up to the EU approved dose of 450 mg per day.

"This is an important step for Avigen and for the clinical development of AV650 for the treatment of spasticity," said Avigen President and Chief Executive Officer Kenneth Chahine, Ph.D., J.D. "It signifies not only the first time that AV650 is studied in the United States, but also the first time that lack of sedation will be formally assessed in patients with spasticity.

"This trial is part of Avigen's overall development plan for AV650," added Chahine. "Going forward, we intend to study AV650 at higher doses and in a variety of patient populations to fully explore its efficacy and safety profile."

Patricia Nance, M.D., clinical professor, Department of Physical Medicine and Rehabilitation, University of California, Irvine noted, "Many patients suffering from spasticity find it difficult to tolerate currently available therapies due to sedation and other factors. We are encouraged by the European experience with AV650 and the promise that AV650 can provide patients relief of spasticity symptoms without the limiting side effects associated with these therapies."

About AV650

AV650 is being developed in the North American market for the treatment of disabling neuromuscular spasticity and spasm under a license and supply agreement with Sanochemia Pharmazeutika AG. AV650 is an orally administered centrally acting small molecule marketed for the treatment of neuromuscular spasticity and spasm in Europe and Asia, including Germany, Switzerland, Austria, and Japan. Avigen's development program will build on the extensive ex-U.S. safety and efficacy experience with this compound.

About Neuromuscular Spasm and Spasticity

Chronic or recurrent muscle spasm is a sudden, violent, painful contraction of muscles typically associated with serious neurological disorders such as Lou Gehrig's disease (ALS), multiple sclerosis, stroke, spinal cord injury, and cerebral palsy. These painful muscle spasms are often, but not always, associated with spasticity, an abnormality in muscle "tone." Spastic limbs become stiff and rigid because the muscles fail to relax, lacking normal regulation by the damaged nervous system. Both spasticity and sudden, painful muscle spasms can occur as complications of the neurological disorders mentioned above.

About Avigen

Avigen is a biopharmaceutical company focused on unique small molecule therapeutics and biologics to treat serious neurological disorders, including neuropathic pain and neuromuscular spasm and spasticity. Avigen's strategy is to complete the requirements of clinical development for each of the candidates in its product pipeline, and continue to look for opportunities to expand its pipeline through a combination of internal research, acquisitions, and in-licensing, with the goal of becoming a fully integrated commercial biopharmaceutical company committed to its small molecule and biologics neurology products. The company currently has in development AV650 for neuromuscular spasm and spasticity and AV411 for neuropathic pain. Additionally, the company has in development a compound for the treatment of hemophilia A and B, AV513. For more information about Avigen, consult the company's website at http://www.avigen.com.

Statement under the Private Securities Litigation Reform Act

This press release contains forward-looking statements, which include, among others, statements relating to Avigen's intention to study AV650 at doses higher than 450 mg per day in a variety of patient populations, its belief that AV650 may be able to provide patients relief of spasticity symptoms without the limiting side effects associated with other therapies, its belief that it will be able to build on ex-U.S. Tolperisone safety and efficacy experience, and its intention of completing the requirements of clinical development for each of the candidates in its product pipeline; looking for opportunities to expand its pipeline through a combination of internal research, acquisitions, and in-licensing; and becoming a fully integrated commercial biopharmaceutical company. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include those detailed in reports filed by Avigen with the Securities and Exchange Commission, including Avigen's quarterly report on Form 10-Q for the period ended September 30, 2006, under the caption "Risk Factors" in Item 1A of Part 2 of that report, which was filed with the SEC on November 2, 2006.

Webcast

Michael Coffee, Chief Business Officer, will present information about Avigen's AV650 development plan at Cowen and Company's 27th Annual Health Care Conference on Thursday, March 15, 2007, from 9:30 to 10:05 a.m. ET. The presentation will be webcast live and archived on Avigen's website at www.avigen.com.

The Avigen, Inc. logo is available at http://www.primezone.com/newsroom/prs/?pkgid=2981

This news release was distributed by PrimeNewswire, www.primenewswire.com

SOURCE: Avigen, Inc.

Avigen, Inc.
Michael Coffee, Chief Business Officer
(510) 748-7372
Fax: (510) 748-7155
ir@avigen.com
http://www.avigen.com
1301 Harbor Bay Parkway,
Alameda, CA 94502

Primary Endpoint Met in Phase 2 Trial of Daclizumab in Patients With Relapsing Multiple Sclerosis

- Anti-IL-2 receptor antibody significantly reduced the number of new or enlarged lesions compared to placebo; data to be submitted for presentation at upcoming medical meeting -

- Phase 2 monotherapy trial to be initiated -

CAMBRIDGE, Mass. and FREMONT, Calif., March 12 /PRNewswire-FirstCall/ -- Biogen Idec, Inc. (Nasdaq: BIIB) and PDL BioPharma, Inc. (PDL) (Nasdaq: PDLI) announced today that the ongoing CHOICE trial, a Phase 2, randomized, double-blind, placebo-controlled trial of daclizumab, met its primary endpoint in relapsing multiple sclerosis (MS) patients being treated with interferon beta. Patients receiving daclizumab 2 mg/kg subcutaneously every 2 weeks showed a significant reduction in the number of new or enlarged gadolinium-contrast-enhancing lesions (Gd-CELs) at week 24.

Daclizumab is a humanized monoclonal antibody that targets the IL-2 receptor on activated T cells. Study results will be submitted for presentation at an upcoming medical meeting later this year. Based on a joint review of the 24-week data, the companies plan to initiate a Phase 2 monotherapy trial of daclizumab, and to advance the overall clinical development program in relapsing MS.

"We are very pleased to see positive results from the first randomized trial of daclizumab in patients with relapsing MS, and we look forward to advancing the clinical development program with our partner and acknowledged leader in the MS field, Biogen Idec," said Mark A. McCamish, M.D., Ph.D., chief medical officer, PDL BioPharma. "While the week 24 data set will be presented later this year, we are planning to move forward with additional development activities, most notably the initiation of the SELECT trial, which will study daclizumab as a single agent in patients with relapsing MS."

"We congratulate PDL on conducting a successful trial of daclizumab in MS," said Al Sandrock, M.D., Ph.D., senior vice president, neurology research and development, Biogen Idec. "Daclizumab represents an exciting opportunity within our growing MS portfolio. We look forward to initiating the SELECT trial and continuing to work closely with our partner, PDL, in advancing this important clinical program."

The adverse event profile observed to date in this study is generally consistent with the safety profile described in the United States (U.S.) prescribing information for daclizumab. Patients are being followed for an additional 48 weeks after the daclizumab treatment period to further assess safety and efficacy.

The CHOICE trial is evaluating the efficacy and safety of daclizumab or placebo added to interferon beta therapy in 230 patients with active MS who were enrolled at study centers in the U.S. and Europe. Patients were randomized to receive daclizumab 2 mg/kg every two weeks, daclizumab 1 mg/kg every four weeks or placebo added to ongoing interferon beta treatment.

PDL and Biogen Idec entered into a collaboration agreement in 2005 to co-develop and commercialize daclizumab in MS and indications other than transplant and respiratory diseases. Under the collaboration, the companies are also co-developing volociximab (also known as M200), an antibody in Phase 2 development for the treatment of various solid tumors. PDL and Biogen Idec share equally the costs of all development activities and all operating profits for both products within the U.S. and Europe. The companies jointly oversee development, manufacturing and commercialization plans for collaboration products and divide implementation responsibilities to leverage each company's capabilities and expertise. Each party will have co-promotion rights in the U.S. and Europe. Outside the U.S. and Europe, Biogen Idec will fund all incremental development and commercialization costs and pay a royalty to PDL on sales of collaboration products.

About Daclizumab

Daclizumab is a humanized monoclonal antibody that binds to the IL-2 receptor on activated T cells, inhibiting the binding of IL-2 and the cascade of pro-inflammatory events contributing to organ transplant rejection and autoimmune and related diseases. Daclizumab is in development for MS by PDL and Biogen Idec, and separately by PDL in asthma and transplant maintenance. Hoffman-La Roche, Inc. currently markets daclizumab under the name Zenapax(R) under a license from PDL. Zenapax antibody is indicated for the prophylaxis of acute organ rejection in patients receiving renal transplants.

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 PDL BioPharma

PDL BioPharma, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing innovative therapies for severe or life-threatening illnesses. Commercially focused in the acute-care hospital setting, PDL markets and sells its portfolio of leading products in the United States and Canada. A pioneer of antibody humanization technology, PDL promotes this technology through licensing agreements and clinical development of its own diverse pipeline of investigational compounds. PDL's research platform centers on the discovery and development of antibodies to treat cancer and autoimmune diseases. For more information, please visit www.pdl.com .

Forward-looking Statement

The information in this press release should be considered accurate only as of the date of the release. Neither PDL nor Biogen Idec has any intention of updating and specifically disclaims any duty to update the information in this press release for any reason, except as required by law, even as new information becomes available or other events occur in the future. This press release may contain "forward-looking statements" that are based on current expectations and assumptions that are subject to risks and uncertainties. The actual results may differ materially from those in the forward-looking statements because of various factors, risks and uncertainties. In particular, the preliminary results observed in the Phase 2 trial known as CHOICE are based on week 24 data and may not be predictive of the results that would be observed upon review of the full set of data PDL and Biogen Idec plan to obtain through week 72. In addition, these preliminary results may not be predictive of results to be obtained in the additional evaluations and studies that would be necessary to demonstrate daclizumab to be safe and effective in the treatment of patients with relapsing MS, nor can there be assurance that PDL or Biogen Idec will initiate subsequent clinical trials of daclizumab, including the Phase 2 monotherapy trial known as SELECT, which PDL and Biogen Idec are currently planning. For further information regarding factors, risks and uncertainties that may cause such differences, please refer to the filings PDL and Biogen Idec have made with the Securities and Exchange Commission, including the "Risk Factors" sections of PDL's and Biogen Idec's Quarterly and Annual Reports, copies of which may be obtained at the "Investors" section on PDL's website at www.pdl.com, with respect to PDL's filings, and at www.biogenidec.com , with respect to Biogen Idec's filings. All forward- looking statements in this press release are qualified in their entirety by this cautionary statement.

NOTE: Biogen Idec is considered a trademark of Biogen Idec, Inc. PDL BioPharma and the PDL BioPharma logo are considered trademarks of PDL BioPharma, Inc. Zenapax is a registered trademark of Hoffman-La Roche, Inc.

SOURCE PDL BioPharma, Inc.
CONTACT: media, Amy Brockelman, Associate Director, Public Affairs, +1-617-914-6524, or investors, Eric S. Hoffman, Ph.D., Associate Director, Investor Relations, +1-617-679-2812, both of Biogen Idec; or Ami Knoefler, Corporate and Investor Relations, +1-510-284-8851, or ami.knoefler@pdl.com, or Jean Suzuki, Corporate Relations, +1-510-574-1550, or jean.suzuki@pdl.com, both of PDL BioPharma

Web site: http://www.biogenidec.com
Web site: http://www.pdl.com

VACCINEX ANNOUNCES ANTIBODY DEVELOPMENT AND COMMERCIALIZATION ALLIANCE IN MULTIPLE SCLEROSIS AND ONCOLOGY

Rochester, NY - Vaccinex, Inc. announced today that it has entered into a collaboration with Teva Pharmaceutical Industries Ltd. (NASDAQ: Teva) to develop and commercialize VX15, a novel human antibody discovered by Vaccinex. VX15 represents a new targeted therapy that has the potential to improve efficacy in treating Multiple Sclerosis (MS) by both suppressing the body's autoimmune response and blocking damage to the central nervous system. VX15 has also shown the ability to eradicate tumors in animal studies by inhibiting blood flow and starving cancer cells of nutrients and energy. VX15 is one of four Vaccinex antibodies currently in pre-clinical development.

According to the terms of the agreement, Teva will make an equity investment in Vaccinex and pay undisclosed fees, development milestones and royalties on product sales to acquire an exclusive license for the development and commercialization of VX15 in multiple sclerosis and other disease indications. Vaccinex retains rights to oncology indications and will continue to conduct all pre-clinical development activities which will be funded by Teva. Teva will have an option to participate as a co-development partner in oncology after Vaccinex completes Phase I clinical trials.

Teva and existing Vaccinex investor, Pan Atlantic Bank and Trust Limited, are participating as lead investors in Vaccinex's third major financing round, which the company anticipates will exceed $25 million.


"This transaction demonstrates Vaccinex's evolution from an antibody discovery company to a product-based company with a growing pipeline and increasing product development capabilities," said Dr. Maurice Zauderer, Vaccinex's President and CEO. "Teva is a tremendously valuable partner for VX15 due to its broad expertise and leadership in the MS market. We are pleased Teva has recognized that Vaccinex is uniquely poised to be a major player in the antibody market."

Vaccinex, Inc.

Vaccinex is a privately held biotechnology company engaged in the discovery and development of novel therapeutic antibodies. Utilizing its proprietary ActivMAb® technology, Vaccinex can select fully human monoclonal antibodies against targets that would be difficult to address with other technologies. This technology can also be used to fully humanize mouse and other non-human antibodies. The firm is headquartered in Rochester, NY and currently has 48 employees. (Also see the company's website, www.vaccinex.com).

Contacts

Vaccinex: Raymond E. Watkins, Vice President of Operations, 585.271.2700 (x-105)
e-mail: rwatkins@vaccinex.com

Suda Communications: Paul Kidwell, 617.296.3854
e-mail: paulkidwell@comcast.net

Multiple sclerosis drug brings lethal risks, but great promise for some

By John Fauber

Milwaukee Journal Sentinel

MILWAUKEE - Eric Schmitt munches on a roast beef sandwich as an IV hooked up to his arm drips a precious but potentially lethal fluid into his vein.

Schmitt, 35, knows there is a slight chance the new drug might kill him, but without it his multiple sclerosis could flare up, bringing back the lack of feeling in his lower body, vision problems and difficulty walking.

"I didn't have much choice," he says.

Krista Chapman wakes up worried at 3 a.m. on the day of her first treatment.

After a horrible year of MS relapses in 2006, she reckons that the same drug, Tysabri, will reduce the odds of another setback from which she might not recover, sparing her from disorienting vertigo and overpowering fatigue.

But it also could cause a fatal viral infection in her brain. And at 37, she is too young to die, even though the odds of that seem slim.

As the drug, which costs several thousand dollars a month, slowly is infused into the back of her hand, she seems relaxed sitting up in her hospital bed.

For Schmitt and Chapman as well as an untold number of other MS patients, Tysabri has created a dilemma found with few other medications that treat disabling, but rarely fatal, diseases such as MS.

The drug was taken off the market in 2005 after three people out of about 2,900 who had been in clinical trials developed brain infections. Two of them died. There is no treatment for the infection, known as progressive multifocal leukoencephalopathy, or PML. And there is no way of knowing who will get it.

The risk of the complication initially was calculated to be about one in 1,000, but doctors say that is an estimate and no one knows the true risk.

In addition, because Tysabri works by blocking the ability of certain immune cells to get into the brain, it may make patients more susceptible to opportunistic infections in other parts of the body.

The drug was allowed back on the market in July with restrictions and a black box warning, the most serious alert that can be placed on a drug label.

The angst over the infection, in part, has been assuaged by Tysabri's huge promise. There is some indication that it may be twice as effective as other MS drugs and that it can reduce the number of relapses by two-thirds.

"If it wasn't for the (brain infection risk), everybody would be taking it because it is such a powerful drug," said Bhupendra Khatri, a neurologist and medical director of the Regional MS Center at Aurora St. Luke's Medical Center in Milwaukee. "You need to be very selective about who you treat."

Beyond the grim calculus of risk and reward, MS patients may have to factor in another troubling variable: the staggering cost of Tysabri.

The drug has a wholesale price of $2,184 for each vial used for the standard, hourlong monthly infusion session.

At least one infusion site, St. Luke's Medical Center, is billing nearly $10,000 for each monthly treatment.

Potentially, Tysabri patients could be on the drug for years, maybe the rest of their lives, possibly straining the lifetime policy limits of their insurance.

At the two other sites approved for dispensing Tysabri, the price is substantially less. Waukesha Memorial Hospital charges $2,900 for a monthly infusion. University of Wisconsin Hospital and Clinics in Madison bills $4,300. Under Medicaid, Wisconsin pays pharmacies about $2,400 for the drug.

All of those charges may be subject to rebates or discounts, depending on who is paying the bill.

For instance, a claim receipt from one Tysabri patient shows St. Luke's billed Humana Insurance $9,991, minus $3,996 for a plan discount, resulting in a net payment of $5,995. St. Luke's declined to comment on pricing.

A spokeswoman for the drug's maker said the company has no control over how much clinics charge for administering Tysabri. Patient ranks growing

Nationally, about 5,000 patients are taking the drug and another 3,000 are waiting to begin treatment, said Amy Brockelman, a spokeswoman for Biogen Idec, which markets Tysabri along with Elan Pharmaceuticals.

"We believe Tysabri has the potential to eclipse all the other MS therapies over time," she said.

MS is an autoimmune disease that usually is diagnosed in people between the ages of 20 and 50. About 400,000 Americans have the disease; women get the disease about twice as often as men.

In MS, certain immune cells enter the brain or spinal cord and mistakenly cause inflammation that damages myelin, the protective coating on the roots of brain cells. As the myelin becomes damaged, communication between brain cells is disrupted and some cells die, resulting in any of a variety of problems such as difficulty controlling movement, blurred vision and cognitive deficits.

Tysabri prevents the immune cells from getting into the brain. It binds to the surface of the cells and inhibits their movement from the bloodstream to the brain.

This helps prevent the autoimmune attack on the brain, but it also makes the brain more susceptible to a common pathogen known as the JC virus. It is the JC virus that causes the brain infection.

Tysabri essentially turns the brain into a gated community, said John Fleming, a professor of neurology and director of the University of Wisconsin's MS clinic.

"It keeps out all the criminals," Fleming said. "Unfortunately, it also keeps the cops out."

The problem in assessing the risk of Tysabri is that it has been tested for only about two years, he said. No one knows if the brain infection risk grows or diminishes five years out or longer, he said.

"If it turns out to be safe, it could be the predominant treatment for MS," Fleming said. "If there are more cases of (brain infection), it wouldn't surprise me if the FDA took it off the market."

For the moment, Tysabri patients such as Schmitt and Chapman may get some reassurance knowing that all three of the people who developed the brain infection had been on other immune-modulating drugs as well as Tysabri, and that may have contributed to their brain infections. Under the new restrictions that allowed Tysabri back on the market, it must be administered alone.

Schmitt, who was diagnosed with MS in 1998, has been part of a clinical trial to further establish the safety of Tysabri. He got his last infusion last month as part of the trial at St. Luke's. Since he went back on the drug last year, feeling has returned to the lower part of his body and he has never felt better, he said.

For Schmitt, a pharmacist who is married and has a 2-year-old child, his worries about the drug had to be set aside.

"I'm either disabled or still working," he said. "I'm 35. I've got to keep working."

Chapman began considering Tysabri after she was hospitalized because of three separate relapses in 2006. During those setbacks, she had severe vertigo, trouble speaking and swallowing, difficulty seeing and loss of feeling from the waist down.

She still has a great deal of fatigue and, at times, she gets around with a cane, walker or scooter.

"There are days when there is so much fatigue that I can't get out of bed," she said.

Chapman had been on a daily injectable MS drug, but it was losing its effectiveness, she said. She stopped another drug because it caused depression.

"All the neurologists said, 'You have to do something soon,'" she said. "It (going on Tysabri) was frightening. I knew the risk."

Her doctor, neurologist Stanya Smith, said for some patients the drug may be the only way to avoid disabling relapses.

"I have to be convinced in my heart as a physician that it's the only option I have left," said Smith, who manages the MS clinic at Waukesha Memorial.

For Chapman, the final decision was made over Thanksgiving weekend.

About 10 family members, including her husband, Jim, her parents and siblings, gathered at her mother-in-law's home. They each got a vote on whether she should go on Tysabri.

She got her first infusion at Waukesha Memorial last month.

House rejects bill to legalize medical use of marijuana

Barry Massey | The Associated Press
March 9, 2007

A proposal to legalize the medical use of marijuana failed Thursday in the House, dashing hopes of advocates who had picked up the support of Gov. Bill Richardson for the measure.

The Senate previously had approved the proposal, and it would have gone to the governor had it cleared the House. Richardson had said he would sign the proposal into law.

But the House narrowly rejected the bill, with 36 voting against it and 33 supporting it.

Opponents disputed that marijuana was an effective medicine. "Medically it just really has no value. For us to approve a drug like this tells our children and tells the rest of the people in this state that we, somehow as leaders, give tacit approval to the use of this drug," said Rep. John Heaton, D-Carlsbad and a pharmacist. "That is absolutely wrong for us to do."

He described marijuana as "the No. 1 gateway drug to abusing other drugs in our society."




The proposal would have allowed the use of marijuana for pain or other symptoms of debilitating illnesses such as cancer, glaucoma, epilepsy, multiple sclerosis, HIV-AIDS and certain spinal-cord injuries.

Supporters said marijuana could help patients who don't respond to other treatment, such as an individual who suffers from nausea because of treatments for cancer.

"If it offers one person ... the pain relief or the help they need, who are we in this body to say no?" said House Republican Whip Dan Foley of Roswell.

Under the legislation, the Health Department would establish a system for patients to obtain marijuana.

A doctor or other health-care provider would certify to the agency that someone suffers from a qualifying illness.

Patients could not grow marijuana, as in some states that have legalized medical marijuana.

The department would have been responsible for licensing marijuana providers who would produce it in "facilities within New Mexico housed on secured grounds."

Opponents of the bill said marijuana remains illegal under federal law, and patients in New Mexico could be subject to potential federal prosecution.

But Rep. Antonio "Moe" Maestas, D-Albuquerque, said it was the legal responsibility of the state to regulate the practice of medicine within its boundaries. "I think these issues are better left to local practitioners and ill patients than federal bureaucrats," he said.

Initially, the bill failed on a 33-33 tie vote. However, lawmakers immediately reconsidered, and then the measure failed 33-36.

Despite the House vote, advocates vowed to continue their efforts.

"We'll try it till it gets through. We're not going to give up on the state's patient community," said Erin Armstrong, a 25-year-old cancer victim after whom the legislation was named.

"This is a matter of compassion. It's a very personal matter," said Patty Jennings, the wife of Sen. Tim Jennings, D-Roswell.

She is battling cancer and taking morphine, which she said is much more powerful and dangerous than marijuana would be. "People who are not there don't always understand that we're asking ... to have all the options available to us."

Unless states are willing to step forward and challenge the federal government on the issue, the federal policy will never be changed, she said.

The medical marijuana bill is Senate Bill 238.

The Immune Response Corporation Injects First Patient in Trial of NeuroVax for Treatment of Multiple Sclerosis

- Investigational Immune Based Therapy Could Provide New Hope to the 2.5 Million Patients Who Suffer From MS -

CARLSBAD, Calif., March 07, 2007 /PRNewswire-FirstCall/ -- The Immune Response Corporation today announced the injection of the first patient in a large multi-center Phase II study of NeuroVax(TM), an investigational T-Cell Receptor peptide vaccine for the treatment of relapsing-remitting multiple sclerosis (MS). NeuroVax(TM) may represent a significant advance in the treatment of MS, which affects more than 2.5 million people worldwide, including more than 400,000 in the United States.


"We are pleased to initiate this important trial," said Dr. Joseph O'Neill, President and CEO of The Immune Response Corporation. "This study will allow us to examine the potential of NeuroVax(TM) to help patients with multiple sclerosis, to better understand our platform technology in autoimmune diseases, and position our MS program for a strong commercial partnership."

In MS, a specific subset of a patient's own white blood cells, pathogenic T-cells, attack myelin, a fatty tissue in the central nervous system, which surrounds and protects nerve fibers. This pathologic process creates multiple areas of inflammation that ultimately lead to scarring (sclerosis) and that interfere with normal transmission of nerve impulses. This nerve damage, in turn, leads to a variety of chronic and often debilitating neurological symptoms, ranging from serious movement and balance problems to vision impairment.

NeuroVax(TM), which is based on the Company's patented T-cell receptor (TCR) peptide vaccine technology, has shown potential clinical value in the treatment of relapsing forms of MS. NeuroVax(TM) has been shown to stimulate strong, disease-specific cell-mediated immunity in nearly all treated patients. NeuroVax(TM) appears to work by enhancing levels of FOXP3+ regulatory T-cells (Treg cells) which may help regulate expression of pathogenic T-cells in MS patients. Previous clinical trials conducted by the Company and other independent researchers have associated diminished levels of FOXP3+ Treg cell responses with the pathogenesis and progression of MS and other autoimmune diseases such as rheumatoid arthritis (RA), psoriasis and Crohn's disease. In addition to MS, the Company has proprietary technology and prior clinical experience for evaluation of TCR peptide-based immune-based therapies for RA and psoriasis.

"By restoring FOXP3+ Regulatory T-cell functions to levels seen in healthy individuals, NeuroVax(TM) may offer a new and highly targeted mechanism to control pathogenic T-cell activity and limit or prevent nerve tissue damage in MS patients," said Dr. O'Neill. "Additionally, NeuroVax(TM)'s once-a-month dosing, attractive side effect profile and ease of manufacture could benefit the millions of MS patients in need of effective and more tolerable treatment options."

The goal of The Immune Response Corporation's research program is to develop safe, effective and affordable therapies for patients suffering from devastating diseases. The Company's investigational vaccines for MS and other autoimmune diseases, as well as for treatment of HIV, are highly targeted, potentially less toxic medicines that seek to harness the body's own defenses to control and possibly prevent disease. This approach may prove valuable in the discovery of novel immune-based therapies for a host of autoimmune and infectious diseases.

About the Study

This trial is a multi-center, randomized, double-blind, placebo-controlled 48-week study to assess the safety and efficacy of NeuroVax(TM). Two hundred subjects with relapsing-remitting MS, with an Expanded Disability Status Scale (EDSS) score of less than or equal to 5.5 and meeting all inclusion/exclusion criteria, will be enrolled in the study in several Central and Eastern European countries. The first trial patient was injected at a study site in Bulgaria and regulatory approval to begin enrolling has been obtained in Slovakia. Enrollment will continue in other countries as pending regulatory approvals to initiate the trial are approved.

The primary clinical endpoint of the study is to compare the cumulative number of new gadolinium enhancing lesions, a key marker of MS disease activity, using MRI scans at 24, 32, 40, and 48 weeks. Secondary objectives include additional MRI measurements, analysis of clinical relapses, measures of neurologic disability, immunologic evaluations, and safety.

Study participants will be randomized equally to receive NeuroVax (TM) (100 micrograms/mL of each of three selected TCR Peptides), emulsified in Incomplete Freund's Adjuvant (IFA) or placebo (IFA) intramuscularly in the deltoid muscle every four weeks. Evaluation will occur every eight weeks by brain MRI scan and patients will also undergo evaluation by neurology examinations at 12, 24, 36, and 48 weeks. Safety will be monitored by routine physical exams that will be performed at 24 and 48 weeks, and lab tests of hematology, chemistry panel and urinalysis will be performed at weeks 4, 12, 24, 36, and 48.

About The Immune Response Corporation

The Immune Response Corporation is an immuno-pharmaceutical company focused on developing products to treat autoimmune and infectious diseases. The Company's lead immune-based therapeutic product candidates are NeuroVax(TM) for the treatment of MS and REMUNE(R) and IR103 for the treatment of HIV infection. These therapies are in Phase II clinical development and are designed to stimulate disease pathogen-specific immune responses aimed at slowing or halting the rate of disease progression.

NeuroVax(TM), REMUNE(R) and IR103 are in clinical development by The Immune Response Corporation and are not approved by any regulatory agencies in any country at this time. Please visit The Immune Response Corporation at www.imnr.com for additional information.

This news release contains forward-looking statements. Forward-looking statements are often signaled by forms of words such as should, could, will, might, plan, projection, forecast, expect, guidance, potential and developing. Actual results could vary materially from those expected due to a variety of risk factors, including whether the Company will continue as a going concern and successfully raise proceeds from financing activities sufficient to fund operations and clinical trials of NeuroVax(TM), REMUNE(R) or IR103, the uncertainty of successful completion of any such clinical trials, the fact that the Company has not succeeded in commercializing any drug, the risk that NeuroVax(TM), REMUNE(R) or IR103 might not prove to be effective as either a therapeutic or preventive vaccine, whether future trials will be conducted and whether the results of such trials will coincide with the results of NeuroVax(TM), REMUNE(R) or IR103 in preclinical trials and/or earlier clinical trials. A more extensive set of risks is set forth in The Immune Response Corporation's SEC filings including, but not limited to, its Annual Report on Form 10-K for the year ended December 31, 2005, and its subsequent Quarterly Reports filed on Form 10-Q. The Company undertakes no obligation to update the results of these forward-looking statements to reflect events or circumstances after today or to reflect the occurrence of unanticipated events.

REMUNE(R) is a registered trademark of The Immune Response Corporation. NeuroVax(TM) is a trademark of The Immune Response Corporation.


MEDIA CONTACT:
Rachel Kessler
Chamberlain Communications Group Inc.
(212) 389-9155


INVESTOR CONTACTS:
Robert Giordano
ROI Associates
(212) 495-0201


Gene Marbach
Makovsky & Company
(212) 508-9645


COMPANY CONTACT:
Michael K. Green, COO
The Immune Response Corporation
(760) 431-7080

rkessler@chamberlainpr.com rgiordano@roiny.com gmarbach@makovsky.com info@imnr.com

CONTACT: Media, Rachel Kessler of Chamberlain Communications Group Inc.,+1-212-389-9155, , for The Immune ResponseCorporation; or Investors, Robert Giordano of ROI Associates,+1-212-495-0201, ; or Gene Marbach of Makovsky &Company, +1-212-508-9645, , both for The ImmuneResponse Corporation; or Michael K. Green, COO of The Immune ResponseCorporation, +1-760-431-7080, rkessler@chamberlainpr.com rgiordano@roiny.com gmarbach@makovsky.com info@imnr.com

Web site: http://www.imnr.com/

Ticker Symbol: (NASDAQ-OTCBB:IMRP)

Terms and conditions of use apply
Copyright © 2007 PR Newswire Association LLC. All rights reserved.
A United Business Media Company

Curcumin, a Dietary Component, Has Anticancer, Chemosensitization, and Radiosensitization Effects by Down-regulating the MDM2 Oncogene through the PI3

Written by Ricardo Sanchez-Ortiz, MD
Wednesday, 07 March 2007

BERKELEY, CA (UroToday.com) - Curry powder is a mixture predominantly composed of turmeric root extract and other spices such as coriander and fenugreek.

Curcumin, a turmeric root extract, has been shown to possess activity in the treatment and prevention of cancer, multiple sclerosis, and Alzheimer's disease. The molecular mechanism for its anticancer effect is largely unknown, although it is thought to inhibit the synthesis of MDM2, an oncoprotein known to bind p53 and modulate p21 expression.
In the March 1 issue of Cancer Research, Li and colleagues from the Comprehensive Cancer Center of the University of Alabama report on a study designed to elucidate the molecular anticancer effect of curcumin in a preclinical prostate cancer model.

Using PC-3 human prostate cancer cell lines grown in vitro, curcumin was found to decrease the mRNA and protein expression of the oncoprotein MDM2 and to enhance the expression of tumor modulator p21. This translated into an induction of apoptosis and inhibition of proliferation of PC-3 cells grown in culture.

A group of mice xenografts were also developed using the PC-3 cell-line. Curcumin was administered via an oral route to all mice (5 days per week for 4 weeks) except for the control group which only received cottonseed oil. Study groups (5 mice each) were divided as follows: (1) curcumin therapy alone, (2) gemcitabine alone intraperitoneally, (3) radiotherapy alone, and (4) control. Tumor mass was compared at the end of the study. Compared to the control, in all study groups curcumin was found to inhibit the growth of tumors in mice and to enhance the effects of both gemcitabine therapy and radiation therapy.

This well-performed study provides an elegant mechanistic explanation for the anticancer effect of curcumin, which appears to act in a p53 independent manner. These exciting data suggest that this dietary supplement should be studied in combination with traditional forms of chemotherapy or radiotherapy in tumors dependent on the MDM2 pathway.

Mao Li, Zhuo Zhang, Donald L. Hill, Hui Wang, and Ruiwen Zhang

Cancer Res. 2007 Mar 1:67(5): 1988-96.

UroToday.com Prostate Cancer Section

Kennedy urges tough tests for generic biologic drugs

By Diedtra Henderson, Globe Staff | March 7, 2007

WASHINGTON -- Federal regulators charged with approving generic versions of the world's most expensive drugs should follow the lead of their cautious European counterparts, according to Senator Edward M. Kennedy . In Europe, requirements for approval are tailored to the complexity of an experimental drug and can include clinical trials that cost millions for generic manufacturers to conduct.

Tomorrow, the Senate Health, Education, Labor and Pensions Committee, which Kennedy chairs, will hear opposing views about legislation that would give the Food and Drug Administration the ability to approve generic versions of biologic drugs. Name brand biologics, which are based on living organisms, help patients suffering from serious ailments but can cost thousands of dollars per month.

On average, each day the FDA approves one new generic version of a conventional drug that is the chemical equivalent of its branded counterpart and can cost 60 percent less.

But the FDA says it lacks the regulatory power to approve generic versions of expensive specialty drugs, such as insulin , human growth hormone , and biologic therapies that treat multiple sclerosis and anemia . One estimate, disputed by the biotechnology industry, suggests that generic competition for just those four classes of specialty drugs could save $71 billion over the next 10 years .

A bill cosponsored by New York Democratic senators Charles E. Schumer and Hillary Clinton , a member of the Health, Education, Labor and Pensions panel, would open the door for lower-cost generic biologics to enter the US market. Such business leaders as General Motors Corp. and Aetna Inc. , which face staggering increases in their healthcare spending due to specialty biologics, support the legislation.

"We have a responsibility to expand the horizons of medical science in every responsible way possible so people can live longer and fuller lives," Kennedy said yesterday in a statement. "Our goal in legislation should be to enable companies to invest in new medical breakthroughs while doing all we can to cut costs for patients and protect safety."

Following Europe's example would give generic manufacturers guidance about the type of analyses and clinical trials needed to gain FDA regulatory approval, according to a Kennedy staffer.

Kennedy's willingness to require generic-biologic manufacturers to conduct clinical trials is a stance endorsed by local biotech leaders, including Genzyme Corp. and Biogen Idec Inc. Both companies sell brand-name biologic drugs and could face competition from generic versions.

"The public safety is at stake. The public confidence is at stake. You can't force the issue. You have to do it carefully," said Henri Termeer , Genzyme chief executive.

Termeer expects US regulators ultimately will follow the European example, even if it slows approval times for generic biologics. "It's very carefully considered wording where every protein -- because every protein is different -- is considered by itself."

Tim Hunt , a Biogen Idec spokesman, is among those who argue that waiving clinical trial requirements for manufacturers of generic versions of biologics is "lowering the bar on drug safety. To achieve safety, you're probably going to need to run clinical trials," Hunt said.

Schumer and other congressional backers of the bill object to the biotechnology industry's criticism.

"Safety is not an issue here. It's a bogus issue brought by those who wish to prevent change," Schumer said last month when the bill was introduced in the House and Senate. "We can be very smart about how we do this. We want the science to take the lead."

Still, if the bill that passes both houses of Congress follows Europe's lead, it could add millions to the cost of developing generic biologics.

For instance, to satisfy European regulators reviewing its application to sell a generic version of an anemia treatment, Hospira Inc. was asked to conduct a number of analytical studies, preclinical studies, and clinical trials comparing its product to branded versions.

The approval requirements were "quite burdensome," said Terry Gerrard , president of TLG Consulting Inc. and a former FDA reviewer who handled biologic approvals.

Because generic drugs have narrower profit margins than branded versions, a shift toward costly clinical trials could have a chilling impact, said Jim Bianco , chief executive of Cell Therapeutics Inc. The Seattle company recently established a spin-off company, Aequus BioPharma Inc. , to develop a technology that could speed commercialization of generic biologics.
"If the hurdles are too high, even though the markets are attractive, then one looks at the whole time-value-money consideration for where else they make their investments," Bianco said.

Diedtra Henderson can be reached at dhenderson@globe.com.
© Copyright 2007 Globe Newspaper Company.

Attacking Autoimmunity: New Molecular Path to Fight Autoimmune Diseases

Multiple sclerosis, diabetes, and arthritis are among a variety of autoimmune diseases that are aggravated when one type of white blood cell, called the immune regulatory cell, malfunctions. In humans, one cause of this malfunction is when a mutation in a gene called FOXP3 disables the immune cells' ability to function. In a new study published online next week in the Proceedings of the National Academy of Sciences, researchers at the University of Pennsylvania School of Medicine have discovered how to modify enzymes that act on the FOXP3 protein, in turn making the regulatory immune cells work better. These findings have important implications for treating autoimmune-related diseases.

"We have uncovered a mechanism by which drugs could be developed to stabilize immune regulatory cells in order to fight autoimmune diseases," says senior author Mark Greene, MD, PhD, the John Eckman Professor of Pathology and Laboratory Medicine. "There's been little understanding about how the FOXP3 protein actually works." First author Bin Li, PhD, a research associate in the Greene lab has been working on elucidating this process since FOXP3's discovery almost five years ago.

Li discovered that the FOXP3 protein works via a complex set of enzymes. One set of those enzymes are called histone deacetylases, or HDACs. These enzymes are linked to the FOXP3 protein in association with another set of enzymes called histone acetyl transferases that modify the FOXP3 proteins.

Li found that when the histone acetyl transferases are turned on, or when the histone deacetylases are turned off, the immune regulatory cells work better and longer. As a consequence of the action of the acetylating enzyme, the FOXP3 protein functions to turn off pathways that would lead to autoimmune diseases.

"I think this simple approach will revolutionize the treatment of autoimmune diseases in humans because we have a new set of enzymatic drug targets as opposed to the non-specific therapies we now use," says Greene. Non-specific therapies include the use of steroids and certain chemotherapy-like drugs that act on many cell types and have significant side effects.

"Before this work FOXP3 was thought essential for regulatory T-cell function, but how FOXP3 worked was not known," says Li. "Our research identifies a critical mechanism. Based on this mechanism, treatments could be developed to modulate this regulatory cell population."

"In this line of investigation, we have learned how to turn on or off this regulatory immune cell population - which is normally needed to prevent autoimmune diseases - using drugs that are approved for other purposes, but work on these enzymes" notes co-author Sandra Saouaf, PhD, a research associate at Penn.

Li, Greene, Saouaf and Penn colleagues Wayne Hancock and Youhai Chen are now extending this research directly to several mouse models of autoimmune diseases.

National Multiple Sclerosis Society Launches A New Movement By And For People With MS

Exciting New Research, Service Programs, and People Living With MS Fuel the Movement

What Color is MS - Think Orange!

New York, March 5, 2007 – The National Multiple Sclerosis Society is launching a nationwide initiative to rally people across the country to “Join the Movement” to end multiple sclerosis, the number one neurological disease leading to disability in young adults.

In an effort to help make MS more relevant to busy people in a busy world, over the past year, the advertising agency Wieden+Kennedy New York, whose corporate clients include Nike, Coca Cola and Starbucks, has worked pro bono with the MS Society to develop a campaign to totally transform the way MS and the National MS Society is viewed right down to the very color that has been associated with the disease for the past 60 years. The ground-breaking initiative introduces a new way of talking about MS that focuses on the universal elements of what it means to live with this chronic and unpredictable disease. The agency donated over $1 million in time and creative talent.

Join the Movement

Beginning with MS Awareness Week, March 5 -11, the “Join the Movement” initiative will launch across the country. This multi-channel integrated campaign will appear on TV, radio, print, and out of home properties across the country. All creative elements feature real people living with MS.

“The National MS Society is fueled by people united by a common goal – to address the challenges of each person whose life is affected by MS,” says Joyce Nelson, president and CEO of the National MS Society.

To ignite this movement and create a better understanding of MS with a busy public, Wieden+Kennedy and the MS Society focus on the universal truth that movement is inherent to all of our lives. It defines and expresses who we are. But it comes with no guarantees. This concept shapes the new core message about the disease and purpose of the Society: MS stops people from moving. We exist to make sure it doesn't.

Every hour someone is newly diagnosed with MS. “We are committed to building a movement by and for people with MS that will move us closer to a world free of multiple sclerosis,” adds Nelson. “We want to inspire and encourage people to take action to Join the movement to end MS .”

What color is MS?

When you think breast cancer, it's pink; heart disease or AIDS you think red; and testicular cancer you think yellow; but how do you create a public identity for a disease whose symptoms mysteriously come and go and range from numbness and tingling to complete paralysis. Well, now when you think multiple sclerosis and the National MS Society, who address the challenges of each person whose life is affected by MS, you will see Orange!

How the Public can Join the Movement

To support the launch of the Society's new initiative, people everywhere are encouraged to visit jointhemovement.org – a special website developed by the National MS Society to unite and inspire people to take action to end MS. Through volunteering, participating in a MS Walk or MS Bike Ride, donating, and more, people can get involved. The site also features interactive technology that allows all visitors to “make their mark” to end MS – this mark supports the Society's new logo and makes the statement that we are all committed to creating a world free of MS.

MS Changes Lives Forever

Real people with MS moving forward with their lives both join in and tell the story of the Join the Movement campaign. They include a pediatrician who when diagnosed with MS became a neurologist so she could treat fellow MS patients, a former soldier who when forced to retire from the military established what has become one of the fast growing consultant businesses in Oregon and a former TV reporter who is now a mom and the founder of a new radio program for other moms with MS.

The National MS Society is moving research forward by devoting $46 million to funding over 380 research projects around the world including the largest MS collaborative project – nearly $16 million – to repair and protect the central nervous system and a $4 .6 million research grant looking at using sex hormones as a treatment for MS. The Society is also spending over $125 million to provide services to over one million people each year and is introducing this month a special new program “Relationship Matters” to help individuals and their partners minimize the impact of MS on their lives .

See the Movement PSAs and the Join the Movement video

A Campaign That Moves With You, Wherever You Go

The “Join the Movement” campaign has also inspired a wide variety of support from the corporate world from Clear Channel Communications, to Microsoft, to Westfield Shopping Centres to Developers Diversified, to United Airlines to CNN to Telemundo, to WebMD and Wiley Publishing who is releasing an MS For Dummies . Donated time, space and creative services from corporate partners are already approaching $5 million.

The new integrated campaign will appear on a variety of multi-channel outlets. “Essentially, wherever you are and however you experience movement, our new campaign will be there, moving with you towards a world free of MS,” Nelson commented.

Multi-media distribution – PSAs will air on Clear Channel radio and TV, CNN – both cable and airport networks, Lifetime TV, Telemundo, CBS and WOR Radio networks, ads will appear in Sports Illustrated, People, New England Journal of Medicine, and more. WedMD is supporting the Society across its network, which includes web banner and PSA placement and additional hosting of MS video programming. Print and broadcast PSAs in English and Spanish will also be distributed by the Society to over 1,200 TV stations, 3,000 radio stations and 6,000 print outlets.

Online and viral – Microsoft is supporting the campaign through a new “i'm” initiative: every time you have an IM conversation using Windows Live™ Messenger, Microsoft will donate a portion of its advertising revenue to National MS Society; banner ads will appear on several highly trafficked sites including WebMD's MS Health Center, About.com, Mensfitness.com, Oxygen.com, and Clear Channel stations.

Direct to consumer – A special mailing to 1 million people with connections to MS will be distributed with support of the Society's pharmaceutical partners to introduce the new brand and encourage action by joining the movement.

Outdoor and Shopping malls – Westfield Shopping Centres, with more than 60 properties in the US, and Developers Diversified, with more than 20 properties, will be placing signage throughout their locations for all of March. Clear Channel will be placing Movement PSAs in select outdoor locations starting in the Spring.

Flying high – During the month of April United Airlines will air the Society's PSA in its in-flight TV programming, to an estimated audience of between two and four million.

National MS Society Chapter Activities
From coast to coast, the Society's 50-state network of chapters are introducing their own special events to support MS Awareness Week and launch of the “Join the Movement” initiative. They include billboards, banners and displays across their states, go “orange” days, state capitol advocacy days, school programs, health fairs, and alliances with local business and cultural institutions. To find out what is happening in your area, contact your local Society office at 1-800 344-4867.

About Wieden+Kennedy New York
Based in Manhattan, Wieden + Kennedy New York is a full-service advertising agency with a staff of 125. Wieden + Kennedy New York has produced groundbreaking work for clients including ESPN, Nike NYC, Jordan Brand, The National Multiple Sclerosis Society, ONE.org, the ABC Television Network and Sharp. Globally, Wieden + Kennedy is a privately held agency with over $1,028MM in billings and offices in Portland, New York, Amsterdam, London, Tokyo and Shanghai. Clients include Coca-Cola/Powerade, Honda, Miller, Nike and Starbucks.

About Clear Channel Communications
Clear Channel Communications, Inc. (NYSE:CCU) is a global media and entertainment company specializing in "gone from home" entertainment and information services for local communities and premiere opportunities for advertisers. Based in San Antonio , Texas , the company's businesses include radio, television and outdoor displays. More information is available at www.clearchannel.com

Drug-free treatments draw disabled children from afar

Ability Camp features conductive, hyperbaric education and events


CANADIAN PRESS

Six-year-old Kiera Sparks Lucas of Halifax makes her way through a walking drill as camp conductor Krisztina Kelemenne provides encouragement at Ability Camp.

MILFORD, ONT. (Mar 6, 2007)

Lynne Von Flotow and her daughter Eva have held fundraising dances, approached service clubs and put canisters for coin donations on store counters in their hometown of Whitehorse, Yukon.

They have spent more than $10,000 to get to Prince Edward County.

The destination: Ability Camp, a one-storey facility on a back road south of Belleville, established 12 years ago by father and diver medic Kevin Hickling.

Here, disabled children and stroke victims meet for conductive education and hyperbaric oxygen therapy (HBOT). The two natural, drug-free treatments are so effective that some children enter in wheelchairs and walk out five weeks later.

This is the sixth time Von Flotow and her six-year-old daughter, who has cerebral palsy and quadriplegic athetoid, have visited Ability Camp. The first time was when Eva was three.

"We were seeking alternative treatment because mainstream treatment offers us nothing," Von Flotow said.

"As far as therapy goes, we get basically zero. Nothing was hands on. It was all, `you can get this wheelchair or this piece of equipment.' It was all adapting the environment but teaching the kid nothing."

Eva was a premature baby, born at 25 weeks. Hundreds of thousands of dollars were spent in the first six months of her life. But once she was older, she was sent home with no support, Von Flotow said.

When she was a year old, a doctor wrote her a lifetime prescription for diapers. She would never be toilet trained, Von Flotow recalled him saying, and she would probably never talk.

Arriving at Ability Camp, the first question asked of Von Flotow was if Eva was potty trained. When Von Flotow told them she couldn't be, they disputed it.

"They said, 'She can be. You just have to teach her,"' Von Flotow recalls.

Eva has now been toilet trained for nearly two years.

Ability Camp is not magic, nor is it mystical. The miracles that happen here are small, the result of five hours of conductive education per day and daily visits to the hyperbaric oxygen chamber. HBOT involves increasing the level of oxygen going to the brain to stimulate dormant brain cells.

While HBOT is certified by Health Canada for ailments such as thermal burns and carbon monoxide poisoning, other studies have been mixed. The government warns that its benefits for cases of cerebral palsy, multiple sclerosis and stroke are not proven.

But parents such as Von Flotow say otherwise. Eva couldn't talk before she came to the camp, Von Flotow said. Now she says tongue twisters such as "unique New York" while posing for photographs.

Parents and their children travel from as far away as Japan and South America to visit Ability Camp to take advantage of a place that combines the two approaches. Applications recently arrived from Saudi Arabia and South Africa.

Hickling established the camp after being told his daughter Kaitlin, who has cerebral palsy, would never walk.

Hickling refused that diagnosis. He began to investigate alternative therapies, and eventually fulfilled his goal of a low-cost camp for parents like him. Kaitlin is now walking, driving a car and in her second year of university.

Conductive education has its roots in Hungary, and combines aspects of physical therapy and speech pathology. One of Hickling's two "conductors" on staff is from Hungary.

The main thing Ability Camp offers that the mainstream system doesn't is time and attention, Hickling said. The system in Canada offers disabled kids an hour of physical therapy a week, he said. That period of time is too short for most people to excel at anything. Even if kids do learn, he said, they have lost their progress by the next session.

Progress at the camp is very hard work, said Hickling. Ability Camp is the equivalent of a five-week strenuous workout, where disabled children learn to take it to the next level, whether that be learning to roll over, sit up, eat, speak or walk.

Parents are sent home counselled on exercises that will continue the improvement, said Brock Phillimore, Ability Camp's client services manager.

Children and parents stay in 15 dorm-style rooms while at the camp. Lodging is free. The average price for a session of HBOT in the U.S., where the therapy is available in most major cities, is $200 per session. When grouped together as a package at Ability Camp, Phillimore said, the sessions cost less than $100 each.

So if the approach works so well, why is it available only in Prince Edward County, down a back road that people travel from around the world to visit? Why can every kid who needs it not get this service?

Neither Hickling, Phillimore nor Von Flotow can answer that.

It is well known that the earlier the intervention, the better chance for children to improve, Hickling said. But the current mainstream system just does not provide that.

"We're taught to adapt the environment to the kids, but we don't teach the kids to adapt to their environment," he said.

Many doctors simply don't know enough about conductive education and HBOT, Phillimore said. There is also little political will to spread the word about HBOT.

"There is no big money here for people," he said. "It's not like you can patent it and make money off it. There is no reason to push this through."

In the end, Hickling said, assistive devices such as motorized wheelchairs and handicapped-accessible vans have a cost comparable to providing kids with enough physical therapy so they don't need them. When it comes to teaching kids independent skills, he said, the last alternative should be the easy way out.

Von Flotow is trying to change the system. After straining the family finances and struggling with fundraising five times, she took her case to the Human Rights Commission, arguing the Yukon government should be paying for their trips to Ability Camp. After all, she argued, intensive therapy is funded for autistic children, and should also be funded for children with cerebral palsy. In October, the commission ruled with Von Flotow.

A settlement is still being negotiated. Von Flotow is hoping for the best. Their stay ends in early March, and they will be back.

"When I got here, it was like finally someone else saw the potential in my child that I saw," she said, then added with a sigh, "I love this place."

BioMS Medical Trial Update: 14 Months to Interim Data

EDMONTON, Alberta, March 1, 2007--On May 9th, 2006 BioMS announced enrolment of the 200th patient in its pivotal phase II/III clinical trial of MBP8298, a synthetic peptide drug for the treatment of multiple sclerosis (MS). Under the terms of the trial protocol, an interim safety and efficacy analysis will be performed on data from the first 200 patients enrolled when they have completed 24 months of the clinical trial. This interim analysis is now just 14 months away.



--------------------------------------------------------------------------------


Big news from BioMS!
Recently we announced two major milestones…

BioMS cleared by the FDA to initiate a pivotal phase III MS trial

What does this mean for BioMS? The clearance to proceed with a phase III trial in the U.S. is a significant step towards bringing MBP8298 to the worldwide market. There are approximately 400,000 Americans with MS and close to 50% of patients have secondary progressive MS.

Details: The trial named MAESTRO-03 will be a pivotal phase III clinical trial in the US, and will evaluate MBP8298 for the treatment of secondary progressive MS.

The trial is a randomized, double-blind study enrolling approximately 510 patients who will be administered either MBP8298 or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes (up to 75% of all MS patients are HLA-DR2 and/or HLA-DR4 positive).



--------------------------------------------------------------------------------


BioMS completes patient recruitment in MAESTRO-01 MS trial

What does this mean for BioMS? This brings BioMS one step closer to the objective of offering patients a safe and effective first line therapy for the treatment of secondary progressive MS.

Details: The MAESTRO-01 pivotal phase II/III, multi-center, double-blind, placebo-controlled trial is designed to evaluate the safety and efficacy of MBP8298 in patients with SPMS. The study is being conducted at 48 sites across Canada and Europe (10 countries) and will include approximately 550 patients being administered either MBP8298 or placebo intravenously every six months for a period of two years.

To date the trial has successfully passed six safety reviews by its independent Data Safety Monitoring Board.

For more information please contact:
BioMS Medical Corp ? Phone: 780-413-7152 ? www.biomsmedical.com or email info@biomsmedical.com

This information may contain certain forward-looking statements that reflect the current views and/or expectations of BioMS Medical with respect to its performance, business and future events. Such statements are subject to a number of risks, uncertainties and assumptions. Actual results and events may vary significantly.

Calcium is spark of life, kiss of death for nerve cells

OHSU study shows how these ions modulate the function of brain's most powerful circuits

PORTLAND, Ore. - Oregon Health & Science University research shows how calcium regulates the recharging of high-frequency auditory nerve cells after they've fired a burst of signals, and it may have implications for neurological disorders.

The study by scientists at OHSU's Vollum Institute and the University of Arkansas for Medical Sciences, which appears in the current issue of the journal Nature Neuroscience, shows that calcium ions play a greater role in keeping in check the brain's most powerful circuits, such as those used for processing sound signals, than previously thought.

A better understanding of that role could someday help prevent the death of neurons behind some diseases of the brain and spinal cord, such as stroke and multiple sclerosis, the scientists say.

The research, led by postdoctoral fellow Jun Hee Kim, Ph.D., and her advisor, Henrique von Gersdorff, Ph.D., both scientists at the Vollum Institute, found that calcium tempers the activity of a high-throughput sodium pump, located in the plasma membrane covering nerve endings, that controls how quickly and accurately a nerve cell continues firing after an initial burst of spiking activity.

"What's happening in the brain is you have all these action potentials (spikes) that are firing - the action potential is the way you transmit information quickly from neuron to neuron - and when you have an action potential, you have an explosive influx of sodium ions into the cell," von Gersdorff said. "As a result, the cell is depolarized and it needs to be quickly repolarized."

To repolarize a cell so it can continue firing, and do so accurately and at high-input frequencies, the sodium pump ejects three positively charged sodium ions and imports two positively charged potassium ions. The net result is one positive charged is expelled from the cell, causing a hyperpolarization of the cell's membrane potential.

Quick repolarization of the nerve cell is essential. Mature auditory nerve cells fire at frequencies that are 10 to 100 times higher than most high-frequency cells in the brain - 1 kiloHertz, or 1,000 Hertz. Most brain synapses, the space between nerve cells through which impulses are transmitted and received, begin failing beyond 10 Hertz.

"In the last few years, we have been studying high-frequency firing cells in the auditory part of the brain. We found that these cells and nerve terminals are amazing because they can fire at 1,000 Hertz without failures and with high precision," von Gersdorff said. "That discovery in our lab prompted us to ask the question: How is it that these nerve cells can handle all this high-frequency firing?"

Enter calcium, which, by inhibiting the activity of the sodium pump, regulates signal firing, and may conserve energy and keep the high-frequency cells from burning out. But calcium in high levels within a nerve cell can be toxic, so the researchers discovered another purpose for the sodium pump: powering a protein located on the nerve terminal membrane called the sodium-calcium exchanger, which removes the calcium and replaces it with sodium. That action, in turn, triggers the sodium pump, and so on.

The sodium-calcium exchanger "can import high concentrations of sodium from outside the cell, and it uses the gradient of low internal sodium in the cell as a form of energy to get rid of calcium. That energy comes, ultimately, from the sodium pump and its use of ATP, the cells' major fuel," von Gersdorff explained. The pump is "always keeping sodium concentration in the neuron low and that allows the sodium-calcium exchanger protein to constantly exchange sodium for calcium."

Otherwise, if allowed to get too high within the cell, the calcium shuts down the sodium pumps, creating a "vicious loop," von Gersdorff said.

"You then get a simultaneous build-up of calcium and sodium in the cell, and it's 'Goodbye to your neuron.' It goes at some point into an irreversible cycle of death," he said.

One potential therapeutic approach to preventing cell death caused by increasing calcium levels is making the sodium pump more insensitive to calcium. A potential new drug, for example, could "help the neuron to keep extruding sodium so it can help the sodium-calcium exchanger get rid of calcium, thereby not allowing calcium to reach toxic levels," von Gersdorff said.

For the time being, von Gersdorff's lab will continue studying how calcium regulates the sodium pump.

"Our hope is that these basic, fundamental issues will eventually lead to therapeutic strategies that alleviate neuronal damage from ischemia and stroke," he said.


###
In addition to Kim and von Gersdorff, co-authors on the study were Igor Sizov and Maxim Dobretsov, University of Arkansas for Medical Sciences, Little Rock. The study was funded by the National Institute of Deafness and Other Communication Disorders, the American Heart Association, and the National Institute of Diabetes and Digestive and Kidney Diseases.

Contact: Jonathan Modie
modiej@ohsu.edu
503-494-8231
Oregon Health & Science University

To access all OHSU news releases, visit www.ohsu.edu/news/

Cannabis Based Medicine (Sativex®) Relieves Spasms And Stiffness In People With Multiple Sclerosis

Today, a leading neurology journal - European Journal of Neurology (EJN) reports a study1 which shows that Sativex, a cannabis based medicine, significantly reduces intractable spasms and stiffness (spasticity) in people with Multiple Sclerosis (MS).

Spasticity is one of the most common symptoms of MS, occurring in up to 84% of patients1. Spasticity can severely impact quality of life and is one of the most difficult symptoms of MS to treat1.

The study, a randomised, double-blind trial, led by Professor Christine Collin from the Royal Berkshire and Battle NHS Trust, Reading, UK, saw Sativex or placebo added to existing anti-spasticity medication. Sativex demonstrated significant superiority to placebo in reducing spasticity (p<0.05). Further, the addition of Sativex produced a more than 30% improvement in spasticity in 40% of the people treated1.

Fern Andrews, a person with MS who has participated in clinical trials with Sativex, commented: "Spasticity can make the simple daily activities that most people take for granted, seem daunting. Just dressing and moving around the home can be difficult and I often have to rely on a carer for support. With Sativex, I'm able to choose how much I take depending on how bad my symptoms are - which is a real benefit".

Christine Jones, Chief Executive of the MS Trust said, "Effective relief of spasticity is extremely important to people with MS. Spasticity and muscle spasms are not only distressing and painful, they can have a negative impact on quality of life. The results of this study add to the growing body of evidence that cannabis-based medicines can be effective in helping to relieve this common symptom of MS."

About the study published in the European Journal of Neurology:

The six week study was conducted in 189 MS patients, all of whom were experiencing significant levels of spasticity and had failed to gain adequate relief from currently available anti-spasticity medications. Patients enrolled in the study continued to take their existing medication throughout the trial1.

Sativex®:

Sativex (THC:CBD), an endocannabinoid system modulator, is derived from whole plant extracts of two specifically bred cannabis plant varieties. The extracts are combined to produce a standardised formulation containing two major components of cannabis, the cannabinoids D9-tetrahydrocannabinol (THC) and cannabidiol (CBD).

Sativex is formulated into a pump action oromucosal (mouth) spray designed for self-administration by the patient This formulation allows for flexible dosing, ideal for the variable nature of MS. Each spray of Sativex delivers a fixed dose of 2.7mg THC and 2.5mg CBD. Sativex was generally well tolerated in the study.

Sativex has been developed by UK-based GW Pharmaceuticals plc. It is approved as a prescription medicine in Canada for the symptomatic relief of neuropathic pain in adults with MS. Sativex is currently being reviewed by European regulatory authorities for the symptomatic relief of spasticity in MS and, on approval, will be exclusively marketed by Bayer HealthCare in the UK.

Spasticity:

Spasticity results from more than one group of muscles contracting incorrectly, causing spasms or stiffness. Spasms are uncontrollable muscle contractions and can be painful. They can be a particular problem at night causing disruption of sleep. Limbs may shoot away or bend upwards towards the body and severe spasms may make the back arch off the bed or chair.

Stiffness of the limbs is common and can make it difficult to perform normal activities, particularly delicate movements of the hand and fingers. If the leg muscles are affected it can make walking difficult. Pain can be associated with spasticity. Current treatments are often only partially helpful.

About Bayer HealthCare:

Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. The Pharmaceuticals division, Bayer Schering Pharma AG, comprises the following business units: Women's Healthcare, Diagnostic Imaging, Specialized Therapeutics, Hematology/Cardiology, Primary Care, and Oncology. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating diseases. http://www.bayerhealthcare.com

About GW Pharmaceuticals plc:

GW Pharmaceuticals plc is licensed by the UK Home Office to undertake a pharmaceutical research and development programme to develop non-smoked cannabis-based prescription medicines. GW's shares are publicly traded on AiM, a market on the London Stock Exchange.

GW's clinical research program is being carried out by a team of pharmaceutical professionals experienced in drug development and, in particular, the development of plant-based medicines and drug delivery systems. http://www.gwpharm.com

References:

1. Collin C et al. Randomised controlled trial of cannabis based medicine in spasticity caused by Multiple Sclerosis. European Journal of Neurology, March 07

JK Rowling Condemns MS Drug Ban Ahead of Holyrood Debate

EDINBURGH, Scotland, February 28 /PRNewswire/ -- JK Rowling, patron of the MS Society Scotland, has condemned a decision that denies people affected by aggressive multiple sclerosis (MS) access to a new drug on the NHS ahead of a debate in the Scottish Parliament on Thursday (1 March).

The Scottish Medicines Consortium (SMC) advised against the use of Tysabri - a drug for people affected by severe relapsing remitting multiple sclerosis (MS) - on economic grounds back in December.

Jo Rowling, patron of Scotland's largest MS charity, said: "I know from personal experience that MS can have a devastating effect on everyone that comes into contact with it. My mother suffered terribly with MS and it was so frustrating that there was little or nothing doctors could do to help her.

"If a drug can help tackle MS - particularly the very aggressive type of relapsing MS we are talking about - it should not be ruled out because of cost alone.

"Once again, decisions about treatment are being made by accountants rather than clinicians, and I hope MSPs will speak up on behalf of the thousands of families affected by MS across Scotland."

MS Society Scotland director Mark Hazelwood said: "Tysabri is an important treatment choice for the small number of people who suffer repeated, disabling relapses and who don't respond to current MS drugs.

"We at the MS Society believe people affected by MS in Scotland should have the same access to treatments as their counterparts do in Ireland, Germany, the USA and elsewhere. More than 10,000 people are now taking this drug worldwide, but we are barely out of the starting blocks.

"The Minister has indicated that he is not prepared to look again at the SMC's decision, but we very much hope the door is not closed."

Tricia Marwick MSP will be holding a briefing for media and MSPs at the Scottish Parliament today (28 February) in room P1.02 at 6pm, which Mark Hazelwood will attend with neurologist Belinda Weller and Fiona Burns, a person with MS. Thursday's member's debate takes place at 5pm.

Notes to Editors:

- The MS Society Scotland (http://www.mssocietyscotland.org.uk) is Scotland's largest charity dedicated to supporting everyone whose life is affected by MS.


- More than 10,000 people have MS in Scotland, with one in 500 people affected. This is the highest rate in the world.


- MS is the result of damage to myelin - the protective sheath surrounding nerve fibres of the central nervous system - which interferes with messages between the brain and the body.


- For some people, MS is characterised by periods of relapse and remission while for others it has a progressive pattern.

Distributed by PR Newswire on behalf of Multiple Sclerosis Society

PR Newswire Europe Ltd.

209 - 215 Blackfriars Road, London, SE1 8NL
Tel : +44 (0)20 7490 8111
Fax : +44 (0)20 7490 1255
E-mail : info@prnewswire.co.uk
Copyright © 2007 PR Newswire Europe Limited. All rights reserved.
A United Business Media Company.
Terms and conditions of use apply.

Botox 'major advance' in bringing bladder relief

28.02.2007

It has won an army of celebrity fans for banishing crow's feet and frown lines, but the use of Botox to combat bladder problems such as incontinence has been hailed as a 'major advance' by a urology expert.

Christopher Chapple, a visiting professor at Sheffield Hallam University, said poisonous botulinum toxin could be used therapeutically to treat bladder storage and sensation problems such as incontinence and cystitis. Professor Chapple, who is carrying out new research into the treatment at the University's Biomedical Research Centre, said it had successfully helped eighty per cent of cases during recent trials.

He explained in a lecture at Sheffield Hallam that a simple injection of the substance into the bladder lining could bring relief to some of the ten per cent of people in the UK who currently suffer from an overactive bladder, which is resistant to other drug therapy.

He said: "Doctors are now realising the role of the bladder lining as the cause of problems to do with frequent or painful passing of urine. By injecting the patient's bladder lining with botulinum toxin, we can block the release of nerve transmitter substances and sensory nerves, which means that the patient doesn't feel the need to go to the toilet as often. It also means we don't have to rely on intensive drug therapy, or invasive surgery.

"Around ten per cent of the current UK population has an overactive bladder, while nearly a third of us will experience bladder storage or sensation problems at some point in our lives.

"The bladder normally stores urine at a low pressure, until it can be passed at a socially acceptable time, but some people have problems storing urine and need to go frequently, and urgently. Problems can occur with age, or sometimes as the result of a neurological disorder such as multiple sclerosis.

"Imagine you've come home after a few drinks, you need to pee, and you're fumbling to get the key in the door - that's the sensation some of these people experience every day."

He added: "Treatment with botulinum toxin has been successful in eighty per cent of cases so far. Work is still ongoing, but there is no doubt that it is a major advance that will really improve sufferers' quality of life."

Botulinum toxin, commercially known as Botox, is highly toxic, but is used in minute doses to control muscle spasms. Demi Moore and Madonna have reportedly benefited from its cosmetic, wrinkle-softening effects.

The simple bladder lining treatment lasts between three and six months, and can be administered to outpatients under local anesthetic.

Around fifty people have currently been treated with the botulinum toxin treatment. Professor Chapple and his team are now involved in clinical trials, and will publish further findings at the end of the current, 18-month long research project.

Professor Chapple has a specialist interest in reconstructive surgery and is also working on engineering tissue to carry out urethral reconstruction. Other research is ongoing in the research group to investigate the underlying problems behind bladder and prostate problems.

Christopher Chapple is a Consultant Urological Surgeon at the Royal Hallamshire Hospital, part of Sheffield Teaching Hospitals NHS Trust.

He spoke at Sheffield Hallam University on Wednesday 21 February, 2007.
Kate Burlaga | Quelle: alphagalileo
Weitere Informationen: www.shu.ac.uk/news