Wednesday, December 06, 2006
Phase I Study Includes Lack of Sedation Testing for AV650
ALAMEDA, Calif., Dec. 6, 2006 (PRIME NEWSWIRE) -- Avigen, Inc. (Nasdaq:AVGN) today announced findings from a Phase I clinical trial for AV650 (tolperisone), an oral therapy intended for the treatment of disabling neuromuscular spasticity and spasm. AV650, a New Chemical Entity (NCE) in the U.S., was found to be well tolerated with no evidence of sedation in this trial.
The Phase I study enrolled 30 healthy adult volunteers at one center in the U.S. The double blind, placebo-controlled ascending dose study was designed to evaluate the safety, tolerability and pharmacokinetics, in both fasted and fed individuals, of AV650. In this eight-day study, volunteers were randomized to receive either ascending doses of AV650 up to 450mg/day, or placebo. There were no dose-limiting or dose-related increases in adverse events. Reported adverse events were generally mild in intensity and similar to those previously reported for tolperisone. In addition, there were no drug-related laboratory abnormalities or clinically important changes in cardiovascular parameters. A unique aspect of this study was the assessment of sedation with AV650 utilizing both the CALCAP and VAS. CALCAP is a battery of computerized measures designed to assess sedation and cognitive function, including reaction times, visual discrimination, short-term memory, and attention. The VAS measures a subject's subjective assessment of sedation. Together, the initial findings in this study indicated no significant difference from placebo.
Data from the clinical trial will be submitted for presentation at an upcoming medical meeting.
"We are pleased the results of this first study are consistent with the long-term safety experience with tolperisone and are encouraged with the initial assessment of non-sedation with AV650. Lack of sedation is an important differentiator for AV650, and we plan to continue to assess it in future trials," commented Avigen President and Chief Executive Officer, Kenneth Chahine, Ph.D, J.D. "We look forward to working with clinical investigators in the U.S. to explore further the safety and efficacy of AV650 as a potential non-sedative treatment option for patients with debilitating spasm and spasticity caused by neurological disorders."
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. 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.
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 is currently developing AV650 for spasticity and neuromuscular spasm and two candidates for neuropathic pain, AV411 and AV333. Additionally, the company is advancing toward clinical trials with a novel therapy for the treatment of multiple bleeding disorders, including hemophilia A and B, AV513. For more information about Avigen, consult the company's website at http://www.avigen.com.
This press release contains forward-looking statements, including Avigen's belief that AV650 will differentiate itself from current agents by providing less sedation, that the AV650 Phase I clinical data will support an AV650 Phase II study, that Avigen may be able to initiate an AV650 Phase II study in early 2007, that Avigen will be able to expand its pipeline through internal research, acquisitions, and/or in-licensing, and its belief that it will be able to develop, commercialize or obtain value from its current drug candidates for any indication. 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 marketable product resulting from the effort. 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 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.
CONTACT: Avigen, Inc. Michael Coffee, Chief Business Officer (510) 748-7372 Fax: +1-510-748-7384 firstname.lastname@example.org http://www.avigen.com/ 1301 Harbor Bay Parkway Alameda, CA 94502