ALAMEDA, Calif., Feb. 6, 2007 (PRIME NEWSWIRE) -- Avigen, Inc. (Nasdaq:AVGN) today announced findings from a safety and tolerability study with AV411 (ibudilast), an oral therapy intended for the treatment of neuropathic pain. Ibudilast was approved in Japan over 15 years ago for the treatment of bronchial asthma. Avigen elected to conduct this trial at doses above the prescribed dosage used in Asia to help guide the development of AV411 in patients with neuropathic pain. AV411 was found to be favorably tolerated in this normal volunteer study. Moreover, ibudilast single- and multi-dose pharmacokinetics were characterized, and the findings support a dosing frequency of twice daily.
"These data are promising, given the low incidence of adverse events and the identification of favorable pharmacokinetics," said Kenneth Chahine, Ph.D., J.D., Avigen President and CEO. "Moving forward, we are enthusiastic that AV411 represents a well-tolerated therapeutic candidate with an innovative mechanism of action, which could provide meaningful improvement in patients suffering from neuropathic pain."
Currently, Avigen's AV411 Phase IIa multi-center study initiated in 2006 in Australia continues to enroll according to plan, and the trial is expected to complete later in 2007.
Trial information will be discussed when Avigen holds its fourth-quarter/year-end conference call on Wednesday, February 7th at 8:30 a.m. Pacific. At that time, Avigen will be available for questions regarding the study. Full results of this study will be submitted for publication.
About the Study
The safety, tolerability and pharmacokinetic study enrolled 18 healthy adult volunteers (10 male, 8 female) at the Royal Adelaide Hospital in Adelaide, Australia. The double blind, placebo-controlled study, with single-dose and two-week repeat dose phases, was designed to evaluate the safety, tolerability and pharmacokinetics of AV411. In this 20-day study, volunteers were randomized to receive either 60 mg/day of AV411 or placebo in a 3:1 ratio. The standard dose for ibudilast is 10 mg given three times per day. There were no serious adverse events in the study, and reported events were generally mild in intensity with the most common being headache and nausea. Two subjects ceased study medications as a result of nausea and vomiting. There were no drug-related clinical pathologies or cardiovascular abnormalities. Other side effects such as sedation were similar between active and placebo groups.
"The favorable tolerability found through this exploratory study of AV411 gives us further confidence in studying AV411 for neuropathic pain," explained Paul Rolan, MBBS, MD, Professor and Principal Investigator at the Royal Adelaide Hospital.
Avigen is assembling an Investigational New Drug application to be submitted to the U.S. Food and Drug Administration in early 2007. In addition, Avigen's AV411 is being explored for the treatment of additional neurological indications.
About AV411
AV411 is a first-in-class orally bioavailable small molecule. It is a glial attenuator that suppresses pro-inflammatory cytokines IL-1 beta, TNF alpha, and IL-6, and may increase the anti-inflammatory cytokine IL-10. 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 more than a million patients and has a good post-marketing safety profile in nearly 15,000 patients dosed 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 to investigate glial attenuation as a novel approach to the treatment of neuropathic pain, Avigen discovered that AV411 was efficacious in standard animal models of this condition. While ibudilast was initially developed as a non-selective phosphodiesterase inhibitor for the treatment of bronchial asthma, its efficacy in the treatment of neuropathic pain is not dependent on this activity. Based on its research, Avigen has filed for patents protecting this use of AV411 in multiple clinical indications, and for patents on AV411 analogs which the company believes have the potential to be effective second generation molecules.
About Neuropathic Pain
Neuropathic pain is one of the most challenging medical conditions to treat. It is an extremely complex pain state that is most often preceded by tissue injury, although the pain state can continue after the initial injury has healed. 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 non-steroidal anti-inflammatory drugs or 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 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 with 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.
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This press release contains forward-looking statements, including Avigen's belief that AV411 may provide meaningful improvement in patients suffering from neuropathic pain, the AV411 Phase IIa multi-center study initiated in 2006 in Australia will be complete in 2007, AV411 analogs may be effective second generation molecules, the company may advance AV513 to clinical trials, and 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 September 30, 2006, under the caption "Risk Factors" in Item 1A of Part 2 of that report, which was filed with the SEC on November 2, 2006.