Avigen Announces New Product Development Program for Severe Chronic Pain
December 01 2003 - 8:00AM
PR Newswire (US)
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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