Avigen Announces Positive Data for AV411 in Pain Relief and Drug Addiction

ublished Preclinical Data Reinforces Ongoing Broad Clinical Development of AV411

ALAMEDA, Calif., Feb. 25, 2009 (GLOBE NEWSWIRE) -- Avigen, Inc. (Nasdaq:AVGN), a biopharmaceutical company, announced today that two preclinical reports with glial attenuator AV411 (ibudilast) support the pharmacological effect of the drug on enhancing the pain-killing effect of opioids while reducing the addiction properties of commonly used opioids such as morphine and oxycodone. Both studies are published online in Brain Behavior and Immunity.

"These promising studies support our ongoing clinical trials of AV411 for the treatment of chronic pain and addiction withdrawal, as well as the need and opportunity for a non-opioid alternative in this large market. An estimated 33 million people, or 15 percent of the adult U.S. population, have used prescription drugs for nonmedical reasons in their lifetime, a practice that can lead to abuse and dependence. Current addiction treatment with other opioids is inadequate, and the risk is palpable. There is a significant unmet need here, and AV411, with its strong safety and tolerability record supported by this promising new data, can help meet this need," commented Kenneth Chahine, Ph.D., J.D., Avigen's President and Chief Executive Officer.

"In collaboration with cutting edge researchers at the University of Colorado, Boulder, we have uncovered the potential for AV411 to not only improve the analgesic utility of opioids, but to also reduce the propensity for this class to produce dependence," explained Kirk Johnson, Ph.D., Vice President of Research and Development at Avigen. "In addition, the most recently disclosed neurochemical data support AV411's potential as a new pharmacotherapy for other drug addictions."

"The investigators have provided further evidence that glial cells play an important role in modulating brain activity, and that AV411 may attenuate opioid dependence through its ability to suppress glial cell function," said David McCann, Ph.D., Acting Director of the Division of Pharmacotherapies and Medical Consequences of Drug Abuse at the National Institute on Drug Abuse (NIDA). "These findings drive our continuing support for the Phase 2a clinical trial with AV411 in opioid withdrawal at Columbia University. In addition, the recent studies have provided evidence that AV411 affects an important brain chemical, dopamine, which appears to mediate the rewarding effects of many different drugs of abuse. This raises the possibility that beyond treating opioid withdrawal symptoms, AV411 may have utility in treating cocaine, methamphetamine and other drug addiction disorders. I hope we can facilitate further AV411 development by supporting studies with an expanded focus. There is truly an unmet medical need for new analgesic approaches with less addiction potential as well as new medications to treat drug addiction disorders."

About the Studies

The first paper, "Reduction of Opioid Withdrawal and Potentiation of Acute Opioid Analgesia by Systemic AV411 (ibudilast)," is published in February's edition of Brain Behavior and Immunity. The study, led by Drs. Mark Hutchison and Linda Watkins at the University of Colorado (CU), Boulder (CU) investigated the effect of glial attenuator drugs to alter the analgesic efficacy of opioids like morphine. Additionally, studies were performed to test the hypothesis that attenuating the morphine-induced glial activation in the brain by overlaying AV411 treatment with morphine would yield reduced withdrawal behaviors upon termination of opioid dosing. The data generated from the studies showed that glial attenuators suppress the expression of opioid withdrawal while enhancing acute opioid analgesia.

The second paper,"The Glial Activation Inhibitor AV411 Reduces Morphine-Induced Nucleus Accumbens Dopamine Release," was recently accepted for publication and listed online at Brain Behavior and Immunity. The premise of this study, led by Sondra Bland, Ph.D. in association with Drs. Linda Watkins and Steven Maier at CU, was to examine the impact of glial attenuation with AV411 during a morphine dependence regimen on neurochemical changes in the reward center of the brain. Specifically, levels of the neurotransmitter and neuromediator, dopamine, in the nucleus accumbens (NAc) region were measured during a challenge dose of morphine in opioid-dependent rats. Behavioral signs of withdrawal were also assessed. Dr. Bland et al. found that vehicle-treated rats exhibited a significant morphine-induced increase of NAc dopamine release versus the AV411-treated rats across a broad range of time. Moreover, withdrawal symptoms were likewise reduced in the AV411-treated rats. As increased NAc dopamine levels are evident in other drug addiction or compulsive behavior indications, the findings pave the way for additional research on AV411 utility in other addiction settings.

About AV411

The AV411 portfolio, which includes proprietary analogs, represents novel, first-in-class, non-opioid drugs for the treatment of several large pain and drug addiction indications. AV411 is currently in a Phase 1b/2a clinical trial funded by the National Institute on Drug Abuse. The program, under current U.S. Food and Drug Administration standards, is able to enter Phase 2 development for pain in the United States based on completed Avigen preclinical development and clinical trials in both healthy volunteers and patients. In addition to the efforts initiated with Pacific Growth Equities LLC for AV411 partnering or sale in the U.S., Avigen continues to work with ProPharma Partners to identify European partnering opportunities for the AV411 program.

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. It has additionally been shown to be a toll-like receptor 4 (TLR4) functional antagonist that may contribute to its attenuation of neuroinflammation. While considered a New Molecular Entity (NME) in the United States and Europe, the drug was first approved in Japan more than 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 as reported in nearly 15,000 patients studied at the prescribed doses.

About Avigen

Avigen is a biopharmaceutical company that has focused on identifying and developing differentiated products to treat patients with serious neurological and other disorders. Avigen's strategy is to identify, acquire and develop opportunities that represent a positive return to Avigen's shareholders. Avigen's current potential product is AV411 for neuropathic pain and opioid withdrawal and methamphetamine addiction. For more information about Avigen, consult the company's website at www.avigen.com.

The Avigen, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=2981

Statement under the Private Securities Litigation Reform Act

The statements in this press release related to Avigen's strategy, objectives, and plans to identify, acquire and develop opportunities that represent a positive return to Avigen's shareholders, and its beliefs regarding the potential value and utility of AV411, are forward looking statements. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements, including the risk that Avigen will not be able to acquire or develop such opportunities due to monetary, intellectual property, technological or other constraints, and the risk that AV411 will not ultimately receive regulatory approval due to the uncertainty in clinical trials and the regulatory process. In addition, there are many other risks and uncertainties inherent in the development of drug products. 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, 2008, under the caption "Risks Related to Our Business" in Item 2 of Part I of that report, which was filed with the SEC on November 10, 2008.

CONTACT: Michael Coffee, Chief Business Officer Avigen, Inc., 1301 Harbor Bay Parkway, Alameda, CA 94502 510-748-7372 ir@avigen.com www.avigen.com

 

 

Posted: February 2009

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