Monday, September 22, 2008
Top Line Data Expected in Q4 2008
ALAMEDA, Calif., Sep 18, 2008 (GlobeNewswire via COMTEX News Network) -- Avigen, Inc. (Nasdaq:AVGN), a biopharmaceutical company innovating therapeutics for neurological care, today announced the completion of the double-blind portion of its Phase 2b trial for AV650 (tolperisone HCl) in the treatment of spasticity associated with multiple sclerosis (MS). This Phase 2b spasticity trial is evaluating the safety, tolerability and efficacy of AV650 in MS patients at doses up to 900mg/day for one month followed by an open-label safety extension. The trial is being conducted in top MS centers in Germany and several other European countries.
"The completion of this trial in less than a year marks a significant milestone for the AV650 program and Avigen," said Kenneth Chahine, Ph.D., J.D., Avigen's President and Chief Executive Officer. "The rapid enrollment further supports the need for new and non-sedating agents to treat spasticity, and we have confidence that our planned Phase 3 trials can be completed in a similar timeframe. While the blinded portion of the trial is complete and will report before the end of 2008, more than 90% of the patients have elected to participate in the on-going open-label extension and will continue to receive AV650 for up to an additional twelve months."
Avigen is developing AV650 for commercialization in the North American market for the treatment of disabling neuromuscular spasticity and spasm under a license and supply agreement with Sanochemia Pharmazeutika AG, Vienna, Austria. AV650 is considered a New Chemical Entity (NCE) in the United States.
Tolperisone is an orally administered, centrally acting small molecule marketed for the treatment of neuromuscular spasticity and spasm in Europe and Asia. Avigen's U.S. development program is designed to build on the extensive ex-U.S. safety and efficacy experience with this compound. Versions of tolperisone have been approved for marketing in Germany for over 10 years. Sanochemia and its European marketing partner, Orion Pharma, currently market a proprietary 150mg tablet formulation of tolperisone in Germany under the brand name Viveo(r).
Spasticity is considered one of the main symptoms of the more than 2.5 million people with MS worldwide, affecting up to 60% of this population. Randall Schapiro, M.D, Director of The Schapiro Center for Multiple Sclerosis at the Minneapolis Clinic of Neurology and Clinical Professor of Neurology at the University of Minnesota, commented, "MS patients must cope with significant side effects from currently available treatments for spasticity, including drowsiness, fatigue and cognitive impairment. These side effects do affect their quality of life. We recognize the need for better-tolerated, non-sedating therapies in the United States, and we are encouraged by the European experience of tolperisone."
About the Trial
This double-blind, randomized clinical trial is being conducted in 27 MS centers in Germany and other European countries. It will evaluate safety, tolerability, pharmacokinetics and efficacy in up to 150 MS patients suffering from spasticity. This trial is being conducted to Good Clinical Practice standards by a leading international contract research organization. Following a four-week double blind assessment, patients are offered the opportunity to continue for up to twelve months in an open-label safety phase. The primary efficacy endpoint is the Ashworth scale, a standard tool used in the clinic to measure increased movement. Secondary endpoints include Brief Pain Index (BPI), painful spasm diaries, and clinical impression of change.
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. Spasticity is a common symptom in multiple sclerosis, which affects 2.5 million worldwide.
Avigen is a biopharmaceutical company focused on developing and commercializing small molecule therapeutics 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 that remains committed to its neurology products. Avigen is currently developing AV650 for spasticity and neuromuscular spasm and AV411 for neuropathic pain, as well as opioid withdrawal and addiction in collaboration with the National Institute of Drug Abuse. Additionally, the company is advancing AV513, a novel therapy for the treatment of multiple bleeding disorders, including hemophilia A and B, toward clinical trials. For more information about Avigen, consult the company's website at www.avigen.com.
Statement under the Private Securities Litigation Reform Act
The statements in this press release relating to Avigen's expectations regarding the timely and reliable completion of its clinical trials, its expectations regarding reporting AV650 Phase 2 top-line data in the fourth quarter of 2008, its expectations regarding initiating and completing planned Phase 3 clinical trials in a similar timeframe to the Phase 2b spasticity trial in patients with MS, and its goal of becoming a fully integrated commercial biopharmaceutical company remaining committed to its neurology products are forward-looking statements. 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, among others, the fact that development of small molecule therapeutics and other therapeutic discovery and development is a time- and resource-intensive process, which may result in the expenditure of a significant amount of time and resources with no progress towards clinical trials or marketable product resulting from the effort; the risk that Avigen will not be able to obtain regulatory approvals for its drug products, which is required prior to marketing drug products; and the risk that early positive preclinical and clinical results will not guarantee that the potential products will ultimately be effective in treating the indications for which they are developed, or exhibit the unique properties they appear to possess. In addition, there are many other risks and uncertainties inherent in the development of drug products. Other risks and uncertainties relating to Avigen are 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 June 30, 2008, under the caption "Risks Related to Our Business" in Item 2 of Part I of that report, which was filed with the SEC on August 11, 2008.
This news release was distributed by GlobeNewswire, www.globenewswire.com
SOURCE: Avigen, Inc.
Michael Coffee, Chief Business Officer
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