Avigen data shows AV513 safe, improves bleeding times in animal model

By Lisa Kerner

Erie, Pa., May 24 - Avigen, Inc. presented data for its orally administered drug candidate, AV513, for the treatment of hemophilia and related bleeding disorders at the 2006 World Federation of Hemophilia Congress in Vancouver, B.C.

AV513, a particular type of fucoidan, was shown to be safe and improves the bleeding times in a naturally occurring animal model of severe hemophilia A, according to a company news release.

Fucoidan was administered subcutaneously or orally twice daily in intermittent, weekly escalating doses over several months. All of the study animals showed dose-dependent improvements in cuticle bleeding times and plasma thrombelastogram profiles. Avigen said fucoidan was well tolerated with no adverse side effects and no change in Factor VIII activity.

"The pre-clinical evaluation of this agent, either subcutaneously or orally in hemophilic dogs, looks very promising in two independent measures of how blood clotting occurs," hemophilia physician and researcher David P. Lillicrap said in the release.

"There is no demonstrable toxicity, and the improvement in hemostasis suggests fucoidan could possibly be an effective adjunctive agent in the management of bleeding conditions such as hemophilia."

AV513, a botanical drug comprising fucoidan which is extracted from sea algae, is believed to improve normal clot initiation and reduces anti-coagulation.

Located in Alameda, Calif., Avigen focuses on unique small molecule therapeutics and biologics to treat serious neurological disorders.

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