Avigen (MM) (NASDAQ:AVGN)
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Avigen Files Investigational New Drug Application With the FDA For AV201 for the
Treatment of Advanced Parkinson's Disease
Team of Leading Researchers at UCSF to Conduct Clinical Trial
ALAMEDA, Calif., Nov. 5 /PRNewswire/ -- Avigen, Inc., a leader in the
development of DNA-based drugs, announced today that it has filed an
Investigational New Drug (IND) application with the Food and Drug Administration
(FDA) seeking clearance to enter clinical testing for AV201, its drug for the
treatment of advanced Parkinson's disease. Upon FDA consent, Avigen's next step
will be to present its clinical protocol for the Phase 1 open-label dose
escalation safety study of AV201 to the Institutional Review Board at the
University of California San Francisco (UCSF) where Avigen intends to conduct
its clinical trial.
Avigen's clinical trial team at UCSF is made up of leading doctors and
researchers in neurology and Parkinson's disease including principal
investigator Michael Aminoff, M.D., D.Sc., the Director of the Parkinson's
Disease Clinic and Research Center, and co-investigators Philip Starr M.D.,
Ph.D., Associate Professor of Neurological Surgery, and Chadwick Christine,
M.D., Assistant Professor of Neurology. Avigen's long-time collaborator Krys
Bankiewicz, M.D., Ph.D., Professor of Neurological Surgery at UCSF, performed
the groundbreaking preclinical research on which the protocol is based.
"I am very excited by the potential of Avigen's approach to treating Parkinson's
disease," said Dr. Aminoff. "I have worked with Parkinson's patients for more
than 30 years and have been involved in many research studies. While treatments
have improved over the years, I have very high hopes that AV201 may be the next
great step forward in treating this serious medical condition."
Parkinson's disease results from the death of dopamine-producing cells in the
substantia nigra, a small region of the brain. Dopamine is required to control
movement and low levels of dopamine result in the typical symptoms of
Parkinson's. These consist of tremor, slowness of voluntary movement, muscle
stiffness or rigidity, shuffling gait, loss of balance, slurred speech and
increasing dependence on others.
Current therapy is the oral administration of levodopa, which is converted in
the brain by the enzyme Aromatic L-Amino Acid Decarboxylase (AADC) into
dopamine. Early in the disease, levodopa works very well to alleviate almost all
of the symptoms. However, as Parkinson's disease progresses, the level of AADC
declines and progressively larger doses of levodopa are required. However,
increasing doses of levodopa cause increasing side effects including a variety
of abnormal movements (dyskinesias), psychosis and hallucinations. Most patients
begin to experience negative side effects within five years of beginning
levodopa therapy and eventually need to limit the dose of levodopa. Further,
levodopa becomes less effective as the disease advances, leading to an
inadequate therapeutic response.
Avigen's AV201 is designed to restore the therapeutic effectiveness of levodopa
by putting the gene for AADC into the striatum of the brain of patients with
advanced Parkinson's disease so that they will respond to a lower dose of
levodopa and not experience debilitating side effects. Current medical
understanding is that AADC's only function is to convert levodopa to dopamine.
Treatment with AV201 is intended to permit the level of dopamine in the brain to
continue to be regulated by the dose of the oral medication consumed.
Primate studies have shown AV201 to be very effective, long-lasting and safe.
The earliest primates with Parkinsonian symptoms to be treated with AV201 were
treated over three and a half years ago. Before they were treated, they did not
respond to low levels of levodopa. After a single administration of AV201 to the
striatum, they continue to show stable expression of AADC and significant
behavioral response to low doses of levodopa. They have not developed
dyskinesias or other debilitating side effects.
About Avigen
Avigen, Inc., based in the San Francisco Bay Area, is a leader in the
development of DNA-based drugs. 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 clinical trial for Avigen's Factor IX
gene therapy product for hemophilia B, Coagulin-B(R), is being conducted at the
Children's Hospital of Philadelphia, Stanford University Medical Center and the
University of Pittsburgh. Avigen is actively enrolling subjects in the
Coagulin-B clinical study. Patients or physicians who would like more
information about enrollment criteria and the study should contact the Clinical
Development Department at or call at 510-748-7379. 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 Avigen's
beliefs regarding the potential of AV201 to treat Parkinson's disease, and to
gain FDA consent to begin clinical trials, 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; and Avigen may experience difficulties
in enrolling suitable trial participants, which would delay the commencement or
continuation of the trials. 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 June 30, 2003, under the caption "Risk Factors" in Item 2 of
Part 1 of that report, which was filed with the SEC on August 8, 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/