AVGN Avigen (MM)

Conference Call Scheduled for 8:00 a.m. PDT / 11:00 a.m. EDT on Monday, June 12, 2006 ALAMEDA, Calif., June 12 /PRNewswire-FirstCall/ -- Avigen, Inc. (NASDAQ:AVGN) today 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-1 beta, TNF alpha, 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. 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. Additional information on AV411 can be found on Avigen's website at http://www.avigen.com/. 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. Avigen President and Chief Executive Officer, Kenneth Chahine, Ph.D., J.D., commented, "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." Paul Rolan M.D., FRACP, Professor of Clinical and Experimental Pharmacology, University of Adelaide noted, "The evidence of AV411's preclinical efficacy, as well as its ability to preserve normal sensation with minimal side effects at effective dosages, makes AV411 a very good clinical candidate for neuropathic pain." Avigen is completing non-clinical studies to support the submission of a U.S. IND at the end of 2006. 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 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 US market for neuropathic pain treatments has been estimated to be approximately $1.5 billion. Conference Call Information Avigen management will host a conference call and webcast today, Monday, June 12, 2006, at 11:00 a.m. EDT (8:00 a.m. PDT). This webcast can be accessed from the Avigen website at http://www.avigen.com/. A web replay will also be available following the call on the company's website. The conference call may be accessed by dialing 866-202-1971 for domestic callers and 617-213-8842 for international callers. The participant passcode is 70822621. A rebroadcast of the call will be available approximately one hour after the live call by dialing 888-286-8010 for domestic callers and 617-801-6888 for international callers. The participant passcode is 17308637. About Avigen Avigen is a biopharmaceutical company focused on unique small molecule therapeutics and biologics 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 committed to its small molecule and biologics neurology products. The company is currently developing AV650 for spasticity and neuromuscular spasm and two candidates for neuropathic pain, AV411 and AV333. Additionally, the company is advancing toward clinical trials a novel therapy for the treatment of multiple bleeding disorders, including hemophilia A and B, AV513. For more information about Avigen, consult the company's website at http://www.avigen.com/. This press release contains forward-looking statements, including Avigen's belief that this dose escalating trial will generate data to support a larger Phase II trial in the U.S., that a U.S. IND will be submitted at the end of 2006, that a U.S. trial will be initiated in 2007, that it will be able to expand its pipeline through internal research, acquisitions, and/or in-licensing, and its belief that it will be able to develop, commercialize or obtain value from its current drug candidates for any indication. 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, among others, the fact that development of small molecule therapeutics and other therapeutic discovery and development is a time- and resource-intensive process, which may result in the expenditure of a significant amount of time and resources with no marketable product resulting from the effort. Other risks and uncertainties relating to Avigen are 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 March 31, 2006, under the caption "Risk Factors" in Item 1 of Part 1A of that report, which was filed with the SEC on May 9, 2006. DATASOURCE: Avigen, Inc. CONTACT: Michael Coffee, Chief Business Officer of Avigen, Inc., +1-510-748-7372, or Web site: http://www.avigen.com/

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