Avigen, Inc., a biopharmaceutical company, has received approval from the U.S. Food and Drug Administration (FDA) to begin its initial clinical trial of AV650, a New Chemical Entity (NCE) for the treatment of neuromuscular spasticity and spasm. AV650 is being developed in North America under a license and supply agreement with Sanochemia Pharmazeutika AG, which markets the compound for neuromuscular spasticity and spasm in Europe and Asia. The Phase I clinical trial will assess the safety, pharmacokinetic profile, and lack of sedation in normal volunteers. Avigen plans to initiate clinical development in the second half of 2006.
AV650 is an orally administered, centrally acting small molecule that aims to provide better tolerability than current treatments, potentially being non-sedative, which would differentiate it from existing treatments. The development program will build on the extensive safety and efficacy experience with the compound in Europe.
Ken Chahine, President and CEO of Avigen, expressed excitement about initiating the U.S. clinical development program for AV650, highlighting the potential for better tolerability and the opportunity to address quality-of-life issues for patients with neuromuscular disorders. Patricia Nance, M.D., Clinical Professor at the University of California Irvine, also expressed encouragement regarding the development of tolperisone, a related compound, and its potential to help patients with these disorders.
Neuromuscular spasticity and spasm are sudden, painful muscle contractions often associated with serious neurological disorders such as Lou Gehrig's disease (ALS), multiple sclerosis, stroke, spinal cord injury, and cerebral palsy. These conditions can lead to stiff and rigid muscles due to a lack of normal regulation by the nervous system. Avigen's strategy involves completing the clinical development requirements for each candidate in its product pipeline, including AV650 for spasticity and neuromuscular spasm, and two candidates for neuropathic pain, AV411 and AV333. Additionally, Avigen is advancing toward clinical trials for a novel therapy for the treatment of multiple bleeding disorders, including hemophilia A and B, AV513.
Avigen is committed to becoming a fully integrated commercial biopharmaceutical company focused on small molecule and biologics for neurological products. For more information about Avigen, please visit their website at 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, and its belief in the potential value of its current drug candidates. These statements are subject to risks and uncertainties, including the time and resources required for drug development, which may result in no marketable product. Further information on these risks can be found in Avigen's SEC filings.
Avigen, Inc.