AVGN Submits New Drug App for Parkinson's Drug

[Murray Charters <mcharters@xxxxxxxxxxxxxx>]

AVGN Submits New Drug App for Parkinson's Drug

Ridgeland, MS, NOV 05, 2003 (EventX/Knobias.com via COMTEX) -- Avigen, Inc. 
(AVGN) announced that it has filed an
Investigational New Drug application with the 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 where Avigen intends to conduct its 
clinical trial. Primate studies have shown
AV201 to be very effective, long-lasting and safe.

SOURCE: MacroWorld Investot


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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 05, 2003 /PRNewswire via COMTEX/ -- 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 the           
rapyandeventuallyneedtolimitthedoseoflevodopa.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 clinicaltrials@xxxxxxxxxx or call at 510-748-7379. 
Additional information on Avigen's
proprietary gene delivery products can be found at 

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 clini     
caltrials,areforward-lookingstatements.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.

SOURCE Avigen, Inc.

CONTACT:  Lise Needham, Associate Director of Investor Relations of
                  Avigen, Inc., +1-510-748-7112, or lneedham@xxxxxxxxxx

URL:           
                  

Keywords:
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SOURCE: PR Newswire / MacroWorld Investor


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