Avigen Announces Approval for AV411 Phase IIa Trial

15-Jun-2006

Avigen, Inc. announced approval to initiate a Phase IIa 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 Phase IIa 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 currently anticipates will be initiated in 2007.

AV411 is a first-in-class orally bioavailable small molecule, a glial attenuator that suppresses pro-inflammatory cytokines IL-1ß, TNFa, and IL-6, and may upregulate the anti-inflammatory cytokine IL-10 . While considered a New Chemical Entity (NCE) in the U.S. and Europe, the drug was first approved in Japan over 15 years ago.

As part of its program investigating glial attenuation as a novel approach to the treatment of neuropathic pain, Avigen discovered that AV411 is efficacious in standard animal models of this condition. While ibudilast was initially developed as a non-selective phosphodiesterase (PDE) inhibitor for the treatment of bronchial asthma, its efficacy in the treatment of neuropathic pain appears to be independent of this activity. 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.

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