Focus On AV411's Unique Mechanism of Action and Broad Potential for the Treatment of Neurological Conditions
ALAMEDA, Calif., June 26, 2007 (PRIME NEWSWIRE) -- Avigen, Inc. (Nasdaq:AVGN), a biopharmaceutical company innovating therapeutics for the treatment of neurological conditions, announced today that Expert Opinion on Investigational Drugs has published an article featuring Avigen's pipeline product, AV411 (ibudilast), a potential first-in-class, non-opioid oral treatment for the management of multiple neurological indications, including neuropathic pain and opioid withdrawal.
"The work on this medication demonstrates the potential of basic neuroscience research, yielding a novel approach to the management of neuropathic pain, enhancement of opiate analgesia, and the management of opiate withdrawal. It's my hope that all these possible avenues will be pursued in addition to further basic research that may uncover other clinical applications of this putative medication," stated Frank Vocci, M.D., Director, Division of Treatment Research and Development, National Institute on Drug Abuse, National Institutes of Health.
According to the National Pain Foundation, neuropathic pain affects up to four million people in the United States. Existing medications, such as opioids, often have modest efficacy in controlling chronic pain because they are targeted specifically to act on neurons. Additionally, opioid use can lead to dependence and withdrawal. Avigen scientists, led by Kirk Johnson, Ph.D., Vice President of Research and Development, in collaboration with researchers at the University of Colorado, Boulder, and the University of Adelaide, Australia, are developing AV411 to address this unmet medical need of controlling chronic pain, while avoiding opioid tolerance and withdrawal.
AV411, in early phase II clinical development in patients with diabetic neuropathic pain, modulat es glial cell function, an important contributor to chronic pain as well as opioid dependence and withdrawal. Glia cells surround and influence neurons that signal pain.
The Expert Opinion in Investigational Drugs article, entitled "Ibudilast (AV411): A New Class Therapeutic Candidate for Neuropathic Pain and Opioid Withdrawal Syndromes," by lead author Annemarie Ledeboer, Ph.D., reports that, through its unique properties, AV411 attenuates or suppresses glial cell activation in brain and spinal cord tissues and is effective in treating pain symptoms. Additionally, the article reports that AV411 potentiates or augments morphine analgesia, while counteracting morphine tolerance, as well as diminishing morphine withdrawal behaviors.
"Based on all the pre-clinical research to date, ibudilast represents a promising new agent for relief of neuropathic pain and may offer a better treatment option for various models of pain ranging from traumatic nerve injury to diabetes to cancer chemotherapy-induced neuropathy," stated Linda Watkins, Ph.D., Professor, Department of Psychology & the Center for Neuroscience, University of Colorado at Boulder. A world-wide leader of glial-related research, Watkins is co-author of the paper, and a long-time Avigen collaborator. "The potential for this agent is far reaching. AV411 may not only treat neuropathic pain, but its novel mechanism of action may also allow it to improve opioid efficacy, giving clinicians a greater offering of pain relief for their patients," added Watkins.
"The publication of this research adds to the increasing recognition of glial attenuation as a potential new paradigm shift in how we treat neuropathic pain and opioid withdrawal," explained Johnson. "We look forward to moving AV411 along in the clinic to bring this new class of pain treatment to the patient as well as to explore its potential for the management of drug dependence."
This article is available online at http://www.expertopin.com/doi/abs/10.1517/135437220.127.116.115
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 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 investigating 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 (PDE) 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, as well as 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 antidepressants.
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 currently has in development AV650 for neuromuscular spasm and spasticity and AV411 for neuropathic pain. Additionally, the company has in development AV513, a compound for the treatment of hemophilia A and B. For more information about Avigen, consult the company's website at http://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 completing the requirements of clinical development for each of the candidates in its product pipeline; looking for opportunities to expand its pipeline through a combination of interna l research, acquisitions, and in-licensing; and becoming a fully integrated commercial biopharmaceutical company. 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 March 31, 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 May 10, 2007.