ALAMEDA, Calif., Aug. 13, 2007 (PRIME NEWSWIRE) -- Avigen, Inc. (Nasdaq:AVGN), a biopharmaceutical company developing innovative therapies for the treatment of chronic neurological conditions, today announced it received approval from the U.S. Food and Drug Administration (FDA) to proceed with the U.S. clinical development of AV411 (ibudilast). The initial U.S. clinical trial for AV411, which is treated as a New Chemical Entity in the United States, will be a Phase I maximum tolerated dose study that is designed to build on data from Avigen’s Phase I and exploratory Phase IIa studies in Australia. This larger U.S. Phase I trial is designed to assess the safety and tolerability of AV411. This trial is also intended to assess the effect of food on AV411 pharmacokinetics and tolerability. In parallel, Avigen’s Australian Phase IIa trial is expected to provide safety and initial efficacy data of AV411 in patients with neuropathic pain and is expected to report by the end of 2007.
