Avigen, Inc. today announced it was given approval from the U.S. Food and Drug Administration to commence its initial clinical trial of AV650. AV650 is a New Chemical Entity (NCE) in the U.S. The initial clinical trial will be a Phase I study to assess the safety and pharmacokinetic profile, as well as AV650's lack of sedation in normal volunteers. Avigen plans to initiate clinical development in the second half of 2006.
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.
Avigen President and Chief Executive Officer Ken Chahine commented, "We are excited to initiate our U.S. clinical development program with AV650 as planned. The European experience with tolperisone indicates it has the promise to provide better tolerability than current agents, and we are eager to see this demonstrated in its development in the U.S. In particular, AV650 has the potential of being non-sedative, an attribute that would clearly differentiate it from current treatments, and which we also plan to assess in this initial safety trial."
Patricia Nance, M.D., Clinical Professor, Department of Physical Medicine and Rehabilitation, University of California Irvine noted, "There continues to be an unmet need in the treatment of patients with neuromuscular disorders. We are encouraged to see the development of tolperisone and hope that it can help address the quality-of-life issues that impair the lives of many patients suffering from these disorders."
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 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 it will be able to initiate clinical development for AV650 in the second half of 2006, that AV650 may provide better tolerability than current agents, 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 March 31, 2006, under the caption "Risk Factors" in Item 1 of Part 1A of that report, which was filed with the SEC on May 9, 2006.
Source: Avigen, Inc.