FROM: Healthcare Mergers, Acquisitions & Ventures Week
September 11. 2004
HEADLINE: AVIGEN, INC.;
FDA clears gene therapy trial for Parkinson disease
Avigen, Inc., (AVGN) announced that the U.S. Food and Drug
Administration
(FDA) has authorized initiation of the phase I-II clinical trial of AV201
for
the treatment of Parkinson disease.
"Mid-to late-stage Parkinson's disease is by and large an untreated
condition. AV201 has shown considerable promise as a treatment in animal
models
of Parkinson's disease, and we are excited to be moving this product into
the
clinic," said Dawn McGuire, MD, Avigen's chief medical officer.
Parkinson disease (PD) is the second most common neurodegenerative
disease,
affecting an estimated two million individuals in the United States and
Europe.
It is characterized by tremor, stiffness, difficulty walking, loss of
balance, and increasing dependence on others for basic daily activities.
Early on, Parkinson disease can be effectively treated with available
medications, primarily levodopa (L-Dopa). After 2 to 5 years, however,
L-Dopa
typically becomes less effective, requiring higher doses to maintain
benefit.
Abnormal involuntary movements and other side effects often limit
treatment at
this stage of the disease.
Avigen's AV201 is designed to restore the therapeutic effectiveness
of
L-Dopa by delivery of a human gene into the striatum of the brain that
enables
more efficient utilization of the drug.
Administration of L-Dopa acts as an "on-off" switch for expression of
the
gene product, potentially adding to the safety of this novel approach to
Parkinson disease.
"After years of encouraging preclinical results, I am gratified that
Avigen
will soon be able to bring this promising new treatment into human
trials,
thereby offering hope to the Parkinson patient community which can
greatly
benefit from better therapeutic alternatives," said Avigen's president
and CEO
Kenneth Chahine, PhD, JD.
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