Avigen Receives Approval to Initiate AV650 Phase II Clinical Development
Avigen, Inc. a biopharmaceutical company developing innovative therapies for the treatment of neurological conditions, today announced it was given approval from the U.S. Food and Drug Administration to commence Phase II clinical development of AV650 (tolperisone).
AV650 is a New Chemical Entity (NCE) in the United States. Tolperisone is approved in several EU member countries for the treatment of spasticity and muscle spasms. Avigen's initial Phase II trial will assess the safety, tolerability, and initial efficacy, as well as AV650's lack of sedation, in spinal cord injury patients suffering from spasticity. This study will be a multi-center, double-blind, placebo-controlled trial and will explore doses up to the EU approved dose of 450 mg per day.
``This is an important step for Avigen and for the clinical development of AV650 for the treatment of spasticity,'' said Avigen President and Chief Executive Officer Kenneth Chahine, Ph.D., J.D. ``It signifies not only the first time that AV650 is studied in the United States, but also the first time that lack of sedation will be formally assessed in patients with spasticity.
``This trial is part of Avigen's overall development plan for AV650,'' added Chahine. ``Going forward, we intend to study AV650 at higher doses and in a variety of patient populations to fully explore its efficacy and safety profile.''
Patricia Nance, M.D., clinical professor, Department of Physical Medicine and Rehabilitation, University of California, Irvine noted, ``Many patients suffering from spasticity find it difficult to tolerate currently available therapies due to sedation and other factors. We are encouraged by the European experience with AV650 and the promise that AV650 can provide patients relief of spasticity symptoms without the limiting side effects associated with these therapies.''
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, including Germany, Switzerland, Austria, and Japan. 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.
Source: Avigen, Inc.