Monday, June 11, 2007
Pipex Pharmaceuticals' Oral TRIMESTA Initiates Enrollment of Phase II/III Clinical Trial for Multiple Sclerosis
$5 Million Grant From National Multiple Sclerosis Society, With Support From NIH
Previous Phase II Demonstrated 79% Reduction in Gadolinium Enhancing Brain (MS Lesion) Volumes (p=0.02) and Exceptional 14% Increase in Cognitive Function (p=0.04)
ANN ARBOR, MI--(Marketwire - June 11, 2007) - Pipex Pharmaceuticals, Inc. (OTCBB: PPEX), a specialty pharmaceutical company developing innovative late-stage drug candidates for the treatment of neurologic and fibrotic diseases, announced today that TRIMESTA (oral estriol), its proprietary therapy for multiple sclerosis (MS) has entered a multi-center, Phase II/III clinical trial for the treatment of women with relapsing-remitting MS. This clinical trial has received a $5 million grant from the National Multiple Sclerosis Society (NMSS) in partnership with the National MS Society's Southern California chapter, with support from the National Institutes of Health (NIH).
Previous Phase II Clinical Trial Results in Relapsing Remitting Multiple Sclerosis
TRIMESTA (oral estriol) has completed an initial 22 month, single-agent, crossover phase II clinical trial in the U.S. for the treatment of MS in relapsing remitting patients, with highly encouraging results. The results showed the total volume and number of enhancing pathogenic myelin lesions (established neuroimaging measurements of disease activity in MS) decreased during the treatment period as compared to a six-month pretreatment baseline period. The median total enhancing lesion volumes decreased by 79 percent (p=0.02) and the number of lesions decreased by 82 percent (p=0.09) within the first three months of treatment with TRIMESTA.
Following a three month drug holiday during which the patients weren't on any drug therapies, TRIMESTA therapy was reinitiated during a retreatment phase of this clinical trial. The relapsing-remitting MS patients again demonstrated a decrease in enhancing lesion volumes of 88 percent (p=0.008) and a decrease in the number of lesions by 48 percent (p=0.04) compared with original baseline scores (1),(2).
Improvement in Cognitive Testing Scores
During this phase II clinical trial, a 14 percent improvement in Paced Auditory Serial Addition Test ("PASAT") cognitive testing scores (p=0.04) was observed in these MS patients at six months of therapy. PASAT is a routine cognitive test performed in patients with a wide variety of neuropsychological disorders such as MS. The PASAT scores were expressed as a mean percent change from baseline and were significantly improved in the relapsing-remitting group.
Dr. Rhonda Voskuhl, Professor of Neurology at the University of California, Los Angeles and inventor of TRIMESTA, commented, "Due to its rapid onset of action, oral activity and high response rate seen in relapsing-remitting MS patients in the initial Phase II clinical trial, TRIMESTA may have an important clinical advantage over current injectable MS treatments. As a neurologist, the improvement in cognitive testing scores may also represent a new paradigm in treating MS patients as well as other neurodegenerative diseases with TRIMESTA."
Dr. John R. Richert, Executive Vice President of Research and Clinical Programs at the National MS Society, stated, "We're encouraged that the National MS Society's funding of the original pilot trial of estriol, which emerged from targeted research on gender differences in MS, has led to this new trial. We are pleased that Pipex and Dr. Voskuhl are committed to advancing the development of this novel approach which could potentially lead to an affordable, oral disease-modifying therapy for this debilitating disease."
Dr. Charles Bisgaier, Pipex's President, stated that, "The active ingredient in TRIMESTA has been marketed for over 40 years in Europe and Asia for the treatment of post-menopausal hot flashes. As we enter this Phase II/III clinical trial of TRIMESTA for treatment of MS, the product's known historical efficacy and tolerability coupled with the promising Phase II clinical trial results in MS patients an exciting new approach to treating this devastating disease with a targeted orally active drug candidate."
Dr. Bisgaier went onto say, "The exceptional increase in cognitive function together with the rapid reduction in lesion volumes and numbers positions TRIMESTA to become therapy of choice in the $10 billion global MS market. We are grateful for this $5 million grant and the support of the NMSS/NIH. We are excited about working with the National MS Society, Dr. Voskuhl and her team in furthering this promising new approach."
About the Phase II/III Clinical Trial
The clinical study is a double-blind, placebo-controlled trial that will take place at seven sites in the U.S., enrolling up to 150 female MS patients. Investigators will administer TRIMESTA to women between the ages of 18-50 who have been recently diagnosed with relapsing-remitting MS. TRIMESTA will be given in combination with subcutaneously injected Copaxone®, a standard treatment for MS. The team is evaluating effects of the treatment combination on relapse rates using several clinical and magnetic resonance imaging measures of disability progression.
The study sites include the University of California, Los Angeles (UCLA), Ohio State University (OSU), Rutgers University (UMDNJ), Washington University, St. Louis, University of Chicago, University of Utah and Wayne State University. For further information on this Phase II/III clinical trial, please visit www.clinicaltrials.gov/.
Pregnancy and MS
Doctors have known for decades that women often experience a sharp drop in MS disease symptoms during the course of pregnancy, specifically in the third trimester when the levels of estriol is being produced at their highest level by the placenta. The list of autoimmune diseases that improve during pregnancy includes multiple sclerosis, rheumatoid arthritis, thyroiditis, uveitis, juvenile rheumatoid arthirits, ankylosing spondylitis with peripheral arthritis and psoriatic arthritis.
A landmark clinical study published in the New England Journal of Medicine, known as the PRIMS study (Pregnancy in Multiple Sclerosis) followed 254 women with MS during 269 pregnancies and for up to one year after delivery. The PRIMS study demonstrated that relapse rates were significantly reduced by 71 percent (p < 0.001) through the third trimester of pregnancy from prebaseline levels and relapse rates then increased by 120 percent (p < 0.001) during the first three months postpartum before returning to prepregnancy rates (3).
TRIMESTA is an orally active, immunomodulatory and anti-inflammatory molecule the has been approved and marketed throughout Europe and Asia for approximately 40 years for the treatment of post-menopausal hot flashes, but has never been introduced in North America. Estriol, the active ingredient in TRIMESTA, is a weak estrogenic-based molecule that is produced in the placenta by women during pregnancy. Estriol is considered to play an important role in the immunologic privilege offered to the fetus during pregnancy and is also thought to be responsible for the spontaneous remission of Th1-mediated autoimmune diseases of women (such as multiple sclerosis and rheumatoid arthritis) during pregnancy, especially during the third trimester. Pipex has an exclusive worldwide license with UCLA (through the Regent of the University of California) to the intellectual property rights surrounding TRIMESTA.
About Multiple Sclerosis (MS)
MS is a chronic, usually progressive disease of the central nervous system in which the immune system attacks and destroys the structure, and therefore degrades the function, of nerve cells. Approximately 400,000 Americans have MS, and virtually every hour someone is newly diagnosed. Most are between the ages of 20 and 50, and women are affected two to three times more often than men. Worldwide, MS may affect 2.5 million individuals.
According to the National MS Society, the economic cost of care for MS patients in the United States including medical and non-medical care, production losses, and informal care exceeds $23 billion annually, or more than $57,000 per U.S. patient per year. Complications from MS may make it harder for people to work and may interfere with their ability to perform common, daily activities. During 2006, combined sales estimates of FDA-approved injectable MS therapies, which include Avonex®, Betaseron®, Copaxone®, and Rebif®, totaled approximately $5.0 billion.
For most people with MS, the disease slowly progresses with a series of unpredictable flare-ups, also called relapses or exacerbations. But for some, the progression of the disease is rapid. Relapses often lead to increasing disabilities such as walking impairment, muscle weakness or speech or vision impairments.
About the National MS Society
The National MS Society is committed to building a movement by and for people with MS that will move us closer to a world free of this disease. The Society funds more MS research, provides more services to people with MS, offers more professional education and furthers more advocacy efforts than any other MS organization in the world. The Society has approximately 500,000 members, including more than 300,000 people with MS, and over 460,000 volunteers who carry out the Society's mission. For further information on the National MS Society, please visit www.nationalmssociety.org.
About Pipex Pharmaceuticals, Inc.
Pipex Pharmaceuticals Inc. is a specialty pharmaceutical company that is developing proprietary, late-stage drug candidates for the treatment of neurologic and fibrotic diseases. Pipex's strategy is to exclusively in-license proprietary, clinical-stage drug candidates and complete the further clinical testing, manufacturing and regulatory requirements sufficient to seek marketing authorizations via the filing of New Drug Applications (NDAs) with the FDA in the US and Marketing Application Authorizations (MAAs) with the European Medicines Evaluation Agency (EMEA). For further information please visit www.pipexpharma.com.
(1) Sicotte NL, Liva SM, Klutch R, Pfeiffer P, Bouvier S, Odesa S, Wu TC, Voskuhl RR. Treatment of multiple sclerosis with pregnancy hormone estriol. Ann Neurol. 2002 Oct. 52(4):421-8.
(2) Soldan SS, Alvarez Retuerto AI, Sicotte NL, Voskuhl RR. Immune modulation in multiple sclerosis patients treated with pregnancy hormone estriol. J Immunol. 2003 Dec 1:171(11):6267-74.
(3) Confavreux, C., Hutchinson, M., Hours, M.M., Cortinovis-Tourniaire, P., and Moreau, T. Rate of pregnancy-related relapse in multiple sclerosis. 1998. Pregnancy in Multiple Sclerosis Group. N Engl J Med 339:285-291.
Copaxone® is a registered trademark of Teva Pharmaceuticals.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, that reflect Pipex Pharmaceuticals, Inc. (the "Company," "we" or "our" "Pipex") current expectations about its future results, performance, prospects and opportunities, including statements regarding the potential use of TRIMESTA ™ for the treatment of Multiple Sclerosis. Where possible, the Company has tried to identify these forward-looking statements by using words such as "anticipates," "believes," "intends," or similar expressions. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, including the risks set forth in our most recent filing on Form 10-QSB and Form 10-KSB filed with the Securities and Exchange Commission. We cannot assure you that we will be able to successfully develop or commercialize products based on our technologies, including COPREXA™, TRIMESTA™, Anti-CD4 802-2, CORRECTA™, EFFIRMA™ and SOLOVAX™ particularly in light of the significant uncertainty inherent in developing, manufacturing and conducting preclinical and clinical trials of new pharmaceuticals and obtaining regulatory approvals, that our technologies will prove to be safe and effective, that our cash expenditures will not exceed projected levels, that we will be able to obtain future financing or funds when needed, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that we will be able to successfully obtain any further grants and awards, maintain our existing grants which are subject to performance, that we will be able to patent, register or protect our technology from challenge and products from competition or maintain or expand our license agreements with our current licensors, or that our business strategy will be successful. All forward-looking statements made in this press release are made as of the date hereof, and the Company assumes no obligation to update the forward-looking statements included in this news release whether as a result of new information, future events, or otherwise.
For Further Information Contact:
Steve H. Kanzer, CPA, Esq.
Chairman and Chief Executive Officer
Tel (734) 332-7800
Thomas Redington (investor relations)
Tel: (203) 222-7399