Healthcare Industry News: cell therapy
News Release - June 28, 2007
Titan Annnounces Completion of Patient Enrollment in Randomized Phase IIb Clinical Study of Spheramine(R) In Parkinson's Disease
SOUTH SAN FRANCISCO, Calif.--(HSMN NewsFeed)--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 Parkinson's disease. A total of 71 patients were treated in the study. Spheramine is being developed by Titan in collaboration with Bayer Schering Pharma AG, Titan's 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 Neurology(1), 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.
Parkinson's 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 Parkinson's disease.
Parkinson's 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.
About Titan Pharmaceuticals
Titan Pharmaceuticals, Inc. (AMEX: TTP ) is a biopharmaceutical company focused on the development and commercialization of novel treatments for central nervous system disorders, cardiovascular disease, bone disease and other disorders. Titan's products in development utilize novel technologies that have the potential to significantly improve the treatment of these diseases. Titan also establishes partnerships with government institutions and other leading pharmaceutical development companies. For more information, please visit the Company's website at www.titanpharm.com.
The press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to the Company's development program and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in development, testing, regulatory approval, production and marketing of the Company's drug candidates, adverse side effects or inadequate therapeutic efficacy of the Company's drug candidates that could slow or prevent product development or commercialization, the uncertainty of patent protection for the Company's intellectual property or trade secrets, and the Company's ability to obtain additional financing. Such statements are based on management's current expectations, but actual results may differ materially due to various factors, including those risks and uncertainties mentioned or referred to in this press release.
(1)Stover, Bakay, et. al.. Intrastriatal Implantation of Human Retinal Pigment Epithelial Cells Attached to Microcarriers in Advanced Parkinson Disease, Archives of Neurology, 2005 Dec; (62):1833-7.
Source: Titan Pharmaceuticals
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