Avigen Completes Phase I Trial for AV650, an Oral Treatment for Neuromuscular Spasm and Spasticity; Phase I Study Includes Lack of Sedation Testing for AV650 07 December 2006
Avigen, Inc. 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 randomised 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 utilising both the CALCAP and VAS. CALCAP is a battery of computerised 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.
Source: PrimeNewswire (06/12/06)