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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/