The phase IIa trial, to be conducted at the Royal Adelaide Hospital in Australia, will evaluate the drug primarily in patients suffering from diabetic neuropathy. The dose-escalating trial is also designed to generate data to support a larger US 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-1 beta, TNF alpha, and IL-6, and may upregulate the anti-inflammatory cytokine IL-10.
AV411 is considered a new chemical entity in the US and Europe but has been approved in Japan for over 15 years. The drug has been prescribed to over a million patients and has a good post-marketing safety profile in nearly 15,000 patients studied at the prescribed doses.
“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,” said Dr Kenneth Chahine, Avigen president and CEO.