Avigen, Inc., a biopharmaceutical company developing innovative therapies for the treatment of chronic neurological conditions, announced that it had received approval from the US Food and Drug Administration (FDA) to proceed with the US clinical development of AV411 (ibudilast).

The initial US 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 US 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.

AV411 is a first-in-class orally bio-available small molecule glial cell attenuator. It down regulates neurological inflammation potentially via suppressing pro-inflammatory cytokines IL-1 beta, TNF alpha, and IL-6. It has other activities that are still being validated. While considered a New Chemical Entity in the United States and Europe, the drug was first approved in Japan for bronchial asthma over 15 years ago. The drug has been prescribed to over a million patients and has a good post-marketing safety profile in nearly 15,000 patients dosed at the prescribed doses. Avigen is currently conducting a phase IIa study of AV411 in Australia for the treatment of diabetic neuropathic pain and was recently approved by the FDA to initiate a large phase I clinical trial in the United States.

"We are excited to initiate the clinical development of AV411 in the United States," said Kenneth Chahine, PhD, J.D., Avigen's president and CEO. "In addition to our preliminary proof-of-concept work ongoing in Australia, the FDA approval of this phase I clinical trial is an important step in Avigen's plans to design larger efficacy studies of AV411 in the United States for neuropathic pain and other indications like opioid withdrawal and dependence."

This first clinical trial for AV411 in the United States builds upon the global development that Avigen initiated in 2006. Earlier this year, Avigen announced findings from an initial safety and tolerability study performed in Australia that supported a dosing frequency of AV411 of twice daily. Avigen currently has a phase IIa trial of AV411 ongoing in Australia to further assess safety and provide a preliminary indication of efficacy in patients suffering from neuropathic pain. Chahine further noted, "While ibudilast is approved in Asia at doses up to 30 mg per day, we are encouraged that our US phase I trial will create a clear path towards further development of AV411 at higher doses which we believe may be optimal for the neurological applications we are pursuing."

"Early development experience with AV411 indicates that it has the potential to provide better tolerability with fewer side effects, like dependence, when compared to many treatments currently available for patients suffering from neuropathic pain," said Kirk Johnson, Ph.D., Avigen's vice president of research and development. "In addition, the combination of data from our preclinical studies and an active IND in the US better positions us for future clinical research in other unmet neurological conditions for which AV411 may be uniquely suited, including opioid withdrawal and dependence and chemotherapy-induced neuropathy."

"There is a clear need for new approaches to the treatment of neuropathic pain. The promise of glial attenuation and AV411 is encouraging," said Wendye Robbins, M.D., Clinical Assistant Professor, Stanford University School of Medicine. "A product that addresses the long-term needs of patients with this disabling affliction would be most welcome in this underserved market." Robbins is also the CEO of Limerick NeuroSciences, Inc. and a consultant to Avigen.