Avigen to start AV411 phase 2a trial for neuropathic pain

By Elaine Rigoli

Tampa, Fla., June 12 - Avigen, Inc. said it plans to start a phase 2a exploratory therapeutic clinical trial with AV411 (ibudilast) at the Royal Adelaide Hospital in Adelaide, Australia, to assess safety, tolerability and preliminary indication of efficacy in neuropathic pain patients.

The trial is a placebo-controlled, double-blinded study primarily in patients suffering from diabetic neuropathy.

This dose-escalating trial is also designed to generate data to support a larger U.S. clinical trial, which Avigen expects to begin in 2007.

Avigen said AV411 is a first-in-class orally bioavailable small molecule, a glial attenuator that suppresses pro-inflammatory cytokines IL-1 beta, TNF alpha, and IL-6, and may upregulate the anti-inflammatory cytokine IL-10.

While considered a new chemical entity in the United States and Europe, the drug was first approved in Japan more than 15 years ago, according to a news release.

Based on its research, Avigen has filed for patents protecting this use of AV411, as well as for patents on AV411 analogs which the company believes have the potential to be effective second-generation molecules.

"AV411 represents an important potential advance toward an ideal pain therapy given its established safety profile, new mechanism of action, long duration of action and non-opiate characteristics. We are excited to be working with the clinical team at Royal Adelaide in this important first trial of AV411 in neuropathic pain patients," president and chief executive officer Kenneth Chahine said in the release.

Based in Alameda, Calif., Avigen is a biopharmaceutical company focused on small-molecule therapeutics and biologics to treat serious neurological disorders, including neuropathic pain and neuromuscular spasm and spasticity.

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