Company Press Release
Titan Initiates Clinical Testing of Spheramine for Parkinson's Disease
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Dec. 6, 1999--Titan
Pharmaceuticals Inc. announced today that it has
received permission from the Food and Drug Administration to begin
patient enrollment for clinical testing of its novel Spheramine(TM)
product for the treatment of Parkinson's disease.
The Phase I/II clinical study is being performed at Emory University
and will assess the safety and preliminary efficacy of Spheramine in
patients with later stage Parkinson's disease. Approximately six to
eight patients with Hoehn and Yahr stage III Parkinson's disease will be
enrolled in the study, which will employ the Unified Parkinson's Disease
Rating Scale (UPDRS) to evaluate potential improvement in Parkinson's
symptoms.
In Parkinson's disease, dopamine deficiency in certain brain regions
causes progressive motor disorders such as rigidity and slowed,
difficult movements of the legs and arms.
Spheramine is a novel cell therapy product in development which
utilizes normal human cells called retinal pigmented epithelial (RPE)
cells. RPE cells secrete dopamine, and can be propagated in cell
culture to produce large amounts of cells, allowing standardization
for therapeutic use.
Spheramine utilizes Titan's proprietary CCM(TM) technology, which
confers greatly improved survival to cells that are implanted into the
central nervous system. Animal experiments utilizing CCM(TM) technology
have demonstrated greatly enhanced long term survival and function of
human cells implanted into the central nervous system, without any
evidence of immune rejection of the implanted cells. Use of the CCM(TM)
technology avoids the need for any immmunosupression, and allows the use
of normal human cells, rather than animal cell sources.
Blinded, controlled studies have previously demonstrated that
Spheramine can reverse Parkinson's-like symptoms and significantly
improve motor function in a validated primate model of Parkinson's
disease.
``We are very pleased to begin this important initial clinical study
of Spheramine,'' stated Dr. Louis R. Bucalo, President and CEO of Titan.
``Unfortunately, most patients with Parkinson's disease eventually lose
benefit from currently available standard therapies. We are hopeful that
an agent such as Spheramine may help restore significant function that
has been lost through disease progression. This initial study is the
first step in assessing such potential benefit.''
Titan Pharmaceuticals, Inc., South San Francisco
Louis R. Bucalo, M.D.
President & CEO
Tel: 650/244-4990
or
Ruder Finn, Inc., New York
Investors:
Wendi B. Green
Account Executive
Tel: 212/593-6374
or
Media:
Sarah O'Connell
Account Executive
Tel: 212/583-2724
Copyright 1994-1999 Yahoo!/Copyright © 1999 Business Wire.
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