Titan Annnounces Completion of Patient Enrollment in Spheramine Trials
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Titan Pharmaceuticals, Inc. (AMEX: TTP) today announced completion of enrollment in the randomized, double-blind Phase IIb clinical study of Spheramine in the treatment of advanced Parkinsons
disease. A total of 71 patients were treated in the study. Spheramine is
being developed by Titan in collaboration with Bayer Schering Pharma AG,
Titans partner for worldwide development and commercialization of Spheramine. Results from the study are expected to be available in the third quarter of 2008.
Results from a previous open label study of Spheramine in six patients,
published in the Archives of Neurology1, demonstrated an average 48 percent improvement in motor function over baseline at 1 year after treatment. Additional follow up data, presented at the International Congress on Parkinson's disease in June 2005, demonstrated continued average improvement in motor function 4 years after treatment of 43 percent. Data from this study also demonstrated significant improvement in quality of life for all patients treated,
with no significant adverse events.
Parkinsons disease results from reduced levels of dopamine production and associated loss of function in specific regions of the brain. Spheramine is a novel cell therapy that
utilizes normal human retinal pigment epithelial cells (RPE cells) delivered by stereotactic injection into specific areas of the brain affected by Parkinsons disease.
Parkinsons disease affects more than one million people in the United States and an estimated four million people worldwide.
Guidance on sales potential and timelines for Spheramine development,
including projected launch of Phase III clinical testing in the second
half of 2008, were recently presented by Bayer Schering Pharma as part
of its Healthcare Investor Day, and can be viewed at www.investor.bayer.com