Avigen's AV411 Highlighted in Special Issue of Neuron Glia Biology
Issue on Pain Highlights AV411 as a New-Class Chronic Neuropathic Pain Drug Candidate
ALAMEDA, Calif., Feb. 26, 2007 (PRIME NEWSWIRE) -- Avigen, Inc. (Nasdaq:AVGN), a biopharmaceutical company developing innovative therapies for the treatment of neurological conditions, announced today that the Cambridge University Press journal Neuron Glia Biology has published online the first article of its special issue about pain, featuring the use of Avigen's product, AV411 (ibudilast), a potential first-in-class oral treatment for the management of chronic neuropathic pain. AV411 is in early phase II clinical development in patients with neuropathic pain.
Avigen scientists, led by Kirk Johnson, Ph.D., Vice President of Research and Development, set out to find potential therapeutic candidates to address the unmet medical need of controlling chronic pain. AV411 was identified based on its glial-attenuating activity and prior human experience in Japan. The pharmacology research article by lead author Annemarie Ledeboer, Ph.D., in collaboration with researchers at the University of Colorado, Boulder, reports that, through its glial cell regulation, AV411 can treat painful neuropathies in animals. Brain and spinal cord glia such as astrocytes and microglia normally respond to neuronal injury to aid repair of nerve damage. However, sometimes the glia in the spinal cord become altered and can aggravate neurons and contribute to the pain. The Avigen researchers showed that AV411 prevents, or attenuates, the hyperactivation of glia, thus relieving painful sensation. Such research may also explain why neuron-targeted drugs provide only partial relief.
"The publication of this research adds to the increasing recognition of glia as both inducers and contributors to chronic neuropathic pain syndromes," explained Johnson. "In just two years, Avigen has identified and advanced into clinical development new applications for AV411 to address the unmet needs of chronic pain. Our collaborations with Dr. Linda Watkins at the University of Colorado, Boulder and Dr. Paul Rolan at Royal Adelaide Hospital in Australia have been instrumental to the research and clinical advancement of AV411 as a new therapy in multiple disease areas."
The results of this preclinical study show AV411 is effective in various models of neuropathic pain ranging from traumatic nerve injury models to a paradigm for cancer chemotherapy-induced neuropathy.
"This research validates the concept that AV411 and its glial regulation significantly reduces the pain behavior in classic animal models of human neuropathic pain," 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 drug to be developed clinically for multiple pain disorders is clear," noted Dr. Watkins.
This article is available online at http://www.journals.cambridge.org/ledeboer.
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.
About Neuron Glia Biology
Neuron Glia Biology serves the expanding need for a scientific journal recognizing that two-way communication between neurons and glia is essential for nervous system function. By focusing on cell-cell interactions in the nervous system, this journal offers an expanded scope that bridges what have traditionally been regarded as separate scientific disciplines.
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 a compound for the treatment of hemophilia A and B, AV513. For more information about Avigen, consult the company's website at http://www.avigen.com.
The Avigen, Inc. logo is available at http://www.primezone.com/newsroom/prs/?pkgid=2981
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 internal 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 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.
Posted: February 2007