SALT LAKE CITY, Nov. 3, 2007 (PRIME NEWSWIRE) -- Avigen, Inc. (Nasdaq:AVGN), a biopharmaceutical company innovating therapeutics for neurological care, today announced first-in-patient top line data for its investigational neuropathic pain product, AV411 (ibudilast). The data was presented by Paul Rolan, M.D., FRACP, Professor of Pharmacology, University of Adelaide, Australia, at the 10th International Conference on the Mechanisms and Treatment of Neuropathic Pain held in Salt Lake City, Utah, on Nov. 1-3. Summary data presented at the meeting showed AV411 was safe and well tolerated in this study at doses up to 80 mg/day. The data also indicated a favorable dose to blood plasma level relationship. Although in this preliminary efficacy trial there appears to be no difference in overall mean visual analog scale (VAS) scores between active and placebo arms, a pharmacokinetic assessment indicates an encouraging correlation between AV411 plasma levels and the number of patients that reported a decrease in pain scores as assessed by VAS. Additionally, there was a trend towards decreased opioid use that correlated with increased AV411 dose.
Rolan noted, "The evidence of AV411's favorable tolerability and potential dose response in this trial indicates AV411 is a promising non-opioid clinical candidate for chronic neuropathic pain. Larger and longer duration studies will be required to demonstrate efficacy over placebo."
"We are pleased with the top line results which met the safety and tolerability objectives of the trial, as well as showed encouraging signs of efficacy in patients with neuropathic pain," said Kenneth Chahine, Ph.D., J.D., Avigen's President and Chief Executive Officer. "This data now provides a valuable roadmap for the planning of our Phase II clinical program for AV411, a non-opioid therapy that can potentially reverse neuropathic pain without dose or therapy limiting side effects."
About the Trial
This exploratory trial of AV411 conducted in two Australian centers was designed to assess the safety, tolerability, pharmacokinetics and preliminary indication of efficacy in patients with neuropathic pain. The Phase IIa trial was a two-week, placebo-controlled, double-blinded study, primarily in patients suffering from diabetic neuropathy. The dose-escalating trial evaluated doses up to 80 mg/day. The trial was also designed to generate data to support larger clinical trials that Avigen currently anticipates will be initiated in 2008.
Earlier this year, Avigen initiated U.S. clinical development of AV411 with a Phase I maximum tolerated dose study. In addition, Avigen's AV411 is being explored for utility in additional neurological indications in which glial cell activation has been implicated as a fundamental contributor to the illness.
About AV411
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 Molecular Entity (NME) in the United States and Europe, the drug was first approved in Japan over 15 years ago. The drug has been prescribed to over one million patients for a different indication and has a good post-marketing safety profile in nearly 15,000 patients studied at the prescribed doses.
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. Additional information on AV411 can be found on Avigen's website at www.avigen.com.
About Neuropathic Pain
Neuropathic pain is an extremely complex pain state that usually is accompanied, at least initially, by tissue injury, although the pain state can continue after the initial injury has healed. It is by far one of the most challenging medical conditions to treat. Nerve fibers may be damaged, dysfunctional or injured, and this in turn sends incorrect signals to other pain centers. It can be an excruciating burning sensation stimulated by a touch that would not normally be perceived as painful, or it can present as constant tingles. Neuropathic pain has a significant negative impact on quality of life.
The precise causes of neuropathic pain are unknown, but conditions associated with the development of neuropathic pain include diabetes mellitus, chemotherapy, shingles, HIV infection, and trauma. Patients are often prescribed NSAIDs, opioids, anticonvulsants, and/or antidepressants, but these are ineffective or only partially effective in many patients and can lead to systemic side effects. Other options are needed to improve outcomes for these patients.
The U.S. market for neuropathic pain treatments has been estimated to be approximately $1.5 billion.
About Avigen
Avigen is a biopharmaceutical company focused on developing and commercializing unique small molecule therapeutics to treat serious neurological disorders, including neuropathic pain and neuromuscular spasm and spasticity. Avigen's strategy is to complete the requirements of clinical development for each of the candidates in its product pipeline, and continue to look for opportunities to expand its pipeline through a combination of internal research, acquisitions, and in-licensing, with the goal of becoming a fully integrated commercial biopharmaceutical company that remains committed to its neurology products. Avigen is currently developing AV650 for spasticity and neuromuscular spasm and AV411 for neuropathic pain. Additionally, the company is advancing toward clinical trials AV513, a novel therapy for the treatment of multiple bleeding disorders, including hemophilia A and B. For more information about Avigen, consult the company's website at www.avigen.com.
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Statement under the Private Securities Litigation Reform Act
This press release contains forward-looking statements, which include, among others, statements relating to Avigen's intention of initiating larger clinical studies of AV411 in 2008; pursuing the use of AV411 for treatment of additional neurological indications; completing the requirements of clinical development for each of the candidates in its product pipeline; continuing to look for opportunities to expand its pipeline; and becoming a fully integrated commercial biopharmaceutical company. Other forward-looking statements include the statements that AV411 may have the potential to provide better tolerability with fewer side effects than existing treatments and that Avigen may pursue development of AV411 for the treatment of opioid withdrawal and dependence and chemotherapy-induced neuropathy. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include those detailed in reports filed by Avigen with the Securities and Exchange Commission, including Avigen's Quarterly Report on Form 10-Q for the period ended June 30, 2007, under the caption "Risks Related to our Business" in Item 2 of Part I of that report, which was filed with the SEC on August 8, 2007.