AVGN Avigen (MM)

Avigen Announces New Product Development Program for Severe Chronic Pain Scientific Publication Introduces New Chronic Pain Paradigm ALAMEDA, Calif., Dec. 1 /PRNewswire-FirstCall/ -- Avigen Inc., announced today that it has launched a new product development program for the treatment of severe chronic pain. A paper published today in Nature Reviews Drug Discovery by Avigen's collaborators Linda Watkins, Ph.D. and Steven Maier, Ph.D., Professors in the Department of Psychology and the Center for Neuroscience at the University of Colorado at Boulder, explains a new paradigm for understanding and treating severe chronic pain that is the basis for Avigen's new initiative. Data from a number of studies presented at the Society of Neuroscience meeting in New Orleans in November demonstrated proof of principle of this approach in several preclinical pain models. "Traditionally, researchers studying pain have focused on the role of neurons. This works well to explain the normal pain of injury, stubbing one's toe for example. However, it does not work well when applied to long-term chronic pain caused by nerve damage or by diseases such as AIDS, shingles or cancer. The drugs developed to control normal pain have been woefully inadequate in controlling chronic pain for most of these patients," said Dr. Watkins. "A new model for the etiology of chronic pain is quickly emerging as researchers around the world are developing a better understanding of the underlying causes of chronic pain." "A growing body of research shows that glial cells play an important role in the creation and maintenance of chronic pain states. Normally, glia are the housekeepers of the central nervous system regulating the environment and cleaning up debris. However, when glia are activated in response to nerve damage, tumors, or particular viruses and bacteria, they produce increased levels of pro-inflammatory substances which greatly enhance the neuron's response to pain signals. In addition, these pain-enhancing substances further activate other glia. When this reaches a critical level, it produces a self-perpetuating feedback loop that potentially can continue even when the original cause of the pain has been resolved. Understanding this new fundamental paradigm may enable the development of entirely new approaches to chronic pain management as the drugs that alter glial function are not the same drugs that have been used to target neurons," Dr. Watkins continued. "Our recent research has focused on the effectiveness of one of the most powerful naturally occurring anti-inflammatory proteins, interleukin-10 (IL-10), to block or reverse glial activation. We believe this approach is very promising as studies of IL-10 in rats have demonstrated that it prevents or reverses every enhanced pain state examined to date. We are excited to be working with Avigen. Together we believe we can take this exciting research and create a potentially revolutionary treatment for the millions of people suffering with severe chronic pain," Dr. Watkins concluded. John Monahan, Ph.D., Avigen's president and CEO, said, "Chronic pain is a large, underserved market. No new class of drugs for severe chronic pain has been approved in over a decade and the currently available drugs are mostly ineffective. We believe delivering the gene for IL-10 to the affected region may reverse glial activation and thereby relieve chronic pain symptoms. This program is highly complementary to our current product development programs for chronic disorders, hemophilia and Parkinson's disease, and builds on our expertise in neurology therapeutics. By targeting the spinal cord, which is immune privileged, we believe we will avoid immune complications which can make systemic delivery more challenging. The method of delivery is also quite straightforward when compared to delivery into other organs." Fifty million Americans suffer from chronic pain, caused by nerve damage as in shingles or diabetes, inflammation as in arthritis, and diseases such as cancer and AIDS. About Avigen Avigen, Inc., based in the San Francisco Bay Area, focuses on the development of DNA-based drugs for serious chronic conditions. Avigen's proposed gene delivery products are designed for direct administration to patients in order to achieve expression of therapeutic proteins within the body. The company is actively enrolling subjects in its clinical trial for Coagulin-B(R), Avigen's Factor IX gene therapy product for hemophilia B, currently being conducted at the Children's Hospital of Philadelphia and Stanford University Medical Center. Patients or physicians who would like more information about enrollment criteria and the study should contact the Clinical Development Department at or call at 510-748-7397. Additional information on Avigen's proprietary gene delivery products can be found at http://www.avigen.com/ Investors Please Note: The statements in this news release regarding the belief that the new paradigm may enable the development of entirely new approaches to chronic pain management, the potential of delivery of the gene for IL-10 to treat chronic pain, and the hope to avoid immune complications, are forward-looking statements. Actual results may differ materially from current expectations due to a variety of factors, including: results in preclinical trials with animals are not necessarily indicative of results that will be obtained in humans; and uncertainty in obtaining or maintaining approvals required by regulatory or institutional authorities due to a number of possible reasons, including unanticipated responses to the treatment. In addition, there are many other risks and uncertainties inherent in the development of gene therapy products. Other risks relating to Avigen are detailed in Avigen's Quarterly Report on Form 10-Q for the period ended September 30, 2003, under the caption "Risk Factors" in Item 2 of Part 1 of that report, which was filed with the SEC on November 13, 2003. DATASOURCE: Avigen Inc. CONTACT: Lise Needham, Associate Director of Investor Relations of Avigen, Inc., +1-510-748-7112, or Web site: http://www.avigen.com/

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