ALAMEDA, Calif., Nov. 4, 2007 (PRIME NEWSWIRE) -- Avigen, Inc. (Nasdaq:AVGN), a biopharmaceutical company innovating therapies for the treatment of chronic neurological conditions, today announced the company presented data from a Phase I study of one of its leading pipeline products, AV650 (tolperisone HCl), at the 37th annual meeting of the Society for Neuroscience (SfN) on November 4, 2007 at the San Diego Convention Center in San Diego, California. This Phase I data showed AV650 to be well tolerated with no evidence of sedation.
Glenn Morrison, Ph.D., Associate Director, Clinical Affairs, presented data from the Phase I study on the safety, tolerability and pharmacokinetics of AV650 in both fasted and fed individuals. AV650 is an oral therapy intended for the treatment of disabling neuromuscular spasticity and spasm. Dr. Morrison's abstract, "AV650 (tolperisone HCl) -- A centrally acting, non-sedative muscle relaxant for the treatment of spasticity, first in human study results" was also selected by the SfN's Public Education and Communication Committee to be included in the SfN press book.
About the Study
AV650, the Avigen formulation of tolperisone HCl, an approved treatment in Europe for spasticity and spasms, is being developed in the United States to treat spasticity associated with neurological indications, such as spinal cord injury and multiple sclerosis. The Phase I study enrolled 30 healthy adult volunteers at one center in the United States. The double blind, placebo-controlled ascending dose study was designed to evaluate the safety, tolerability and pharmacokinetics of AV650 in both fasted and fed individuals. In this first-in-human study, Avigen demonstrated that AV650, when administered to healthy volunteers at a dose up to 450 mg/day, was safe and well tolerated. These findings also showed that AV650 was non-sedating (compared to placebo).
These results may offer significant advantages over current approved treatment regimens for spasticity that typically cause significant side effects, such as drowsiness, that can create issues with treatment compliance. If AV650 proves to be non-sedating through further clinical trials, it could lead to improved treatment and better quality of life for patients who suffer from the debilitating handicap of spasticity. These results help to confirm previous reports from the European literature that demonstrated a good safety profile and found no sedating side effects for tolperisone HCl.
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 Pharmazeutica AG. AV650 is an orally administered centrally acting small molecule marketed for the treatment of neuromuscular spasticity and spasm in Europe and Asia. Avigen's development program will build on the extensive ex-U.S. safety and efficacy experience with this compound.
Currently, Avigen is conducting Phase II studies with AV650 in spinal cord injury in the United States, and multiple sclerosis in Europe.
About Spasticity
Spasticity is a condition in which a muscle has increased tone and resists being stretched. Spasticity can affect up to 60% of people with multiple sclerosis or spinal cord injury. Although the details of how muscles become spastic are still not completely understood, stretch reflexes are known to be involved. In some neurological disorders, including spinal cord injury and multiple sclerosis, stretch reflexes can become hypersensitive and initiate muscle contractions inappropriately. The affected muscles feel tight or stiff and are prone to painful spasms.
While current medications to treat spasticity can be effective, they often have unpleasant side effects, such as sedation or toxicity, which can limit their usefulness. The increased immobility and pain of spasticity, and the sedative effects of common treatments, can make performing daily tasks for these patients even harder.
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 AV513, a compound for the treatment of hemophilia A and B. For more information about Avigen, consult the company's website at www.avigen.com.
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Statement under the Private Securities Litigation Reform Act
This press release contains forward-looking statements, which include, among others, statements relating to Avigen's belief that AV650 may provide better treatment with fewer side effects than other approved treatments, 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 June 30, 2007, 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 8, 2007.