Titan Pharmaceuticals Announces Spheramine Presentations at 12th International Congress of Parkinson's Disease and Movement Disorders
CHICAGO & SOUTH SAN FRANCISCO--Jun 24, 2008 - Titan Pharmaceuticals, Inc. (AMEX:TTP) today announced that Spheramine, the company's novel cell-based therapy being developed in collaboration with Bayer Schering Pharma AG for the potential treatment of moderate to advanced Parkinson's disease, will be featured in two scientific posters presented today at the 12th International Congress of Parkinson's Disease and Movement Disorders in Chicago.
"We continue to be very encouraged by the positive results from this open label pilot study, and of the potential of Spheramine to provide long term benefits to patients with moderate to advanced Parkinson's disease," said Marc Rubin, M.D., President and CEO of Titan. "We expect to have results of our ongoing Phase IIb trial early in the third quarter of this year and look forward to important progress with this program which addresses a critical unmet medical need for Parkinson's patients."
This open-label pilot study was conducted at Emory University Hospital to evaluate the safety, tolerability and preliminary efficacy of Spheramine and enrolled six patients with moderate to advanced Parkinson's disease (PD). Spheramine was administered in the most affected side of the patient's brain using a needle and MRI guidance. The primary exploratory efficacy measure was the change in the Unified Parkinson's Disease Rating Scale (UPDRS) motor sub-score during the practically defined off-state (patients not taking anti-Parkinsonian medications for at least 12 hours), and a preliminary evaluation of health related quality of life (HRQoL) using the Parkinson's Disease Questionnaire (PDQ-39). Substantial improvements from the baseline in UPDRS motor sub-score off medication (44% at year four) and patient reported quality of life scores (23% at year four) have been reported during the last four years, and the presentations today provide details of patient follow-up through year five.
Details of the two presentations are as follows:
"Spheramine Improves Health-Related Quality of Life in Patients with Moderate to Advanced Parkinson's Disease" (Abstract 388) will be presented by Dr. Natividad P. Stover, Assistant Professor of Neurology at the University of Alabama at Birmingham (UAB), on Tuesday, June 24 from 12:30 p.m. to 2:30 p.m. CDT in the Hilton Chicago's Southeast Exhibit Hall.
The objective of this long-term pilot study was to evaluate health-related quality of life (HRQoL) in patients who underwent implantation with Spheramine. Six patients were enrolled and were evaluated across a range of quality of life factors including mobility, stigma, activities of daily living, communication, bodily discomfort, cognition, emotional well-being, and social support for five years following Spheramine implantation. Overall, HRQoL scores improved for all patients from baseline at five years after surgery. Improvement was observed for mobility (41.7%), stigma (40.0%), ADL (33.3%), communication (33.3%), bodily discomfort (25.7%), cognition (19.0%), and emotional well-being (6.1%), while the measure for social support declined (22.2%). These endpoints suggest that unilateral implantation of Spheramine may contribute to enhanced HRQoL in moderate to advanced PD. This result complements the primary outcomes of safety and tolerability in this trial.
"Five-Year Update of the Safety and Efficacy of Unilateral Intrastriatal Implantation of Spheramine" (Abstract 598) will be presented by Dr. Ray L. Watts, Chair of the University of Alabama at Birmingham (UAB) Department of Neurology and Director of Clinical Research, UAB Parkinson's Disease and Movement Disorder Research Program, on Tuesday, June 24 from 12:30 p.m. to 2:30 p.m. CDT in the Hilton Chicago's Northeast Exhibit Hall.
No major new or unexpected safety concerns emerged with the treatment of Spheramine during the first five years of the study. Results of the study demonstrate that Spheramine reduces the severity and frequency of Parkinsonian symptoms in patients who underwent unilateral implantation, and these improvements over baseline appear to continue through 60 months as observed with a mean improvement of 14% in the UPDRS motor sub-score off medication. Although the five-year improvement is modest compared to prior years, this is not unexpected with unilateral treatment, since the hemisphere not receiving an implant remains untreated. The study has been extended to 10 years of evaluation.
Based on the encouraging one-year results in this open-label pilot study, Titan and its partner Bayer Schering Pharma AG initiated a multicenter, double-blind, randomized, sham surgery-controlled study (STEPS) to further evaluate the safety and efficacy of Spheramine. This study completed enrollment with 71 patients last year, and top-line efficacy results are expected to be available early in the third quarter of 2008.
Spheramine is a novel cell-based therapy with promise for the treatment of moderate to advanced Parkinson's disease (PD). Spheramine consists of human retinal pigment epithelial (hRPE) cells attached to a Microcarrier Support Matrix (MSM) for enhanced hRPE cell survival. These cells are found in the inner layer of the retina and produce levodopa. Spheramine is administered in the brain where the levodopa created by hRPE cells is presumably converted into dopamine, the neurotransmitter that is decreased in PD due to a progressive loss of dopaminergic neurons. Spheramine has been granted Fast Track and Orphan Drug status by the FDA.
About Parkinson's Disease
Despite therapeutic advances, there remain substantial limitations to currently approved therapies for the treatment of PD and new approaches are needed. It is estimated that 60,000 new cases of PD are diagnosed each year, adding to the estimated one to 1.5 million Americans who currently have the disease. The latest epidemiology studies indicate that worldwide numbers will increase from an estimated 4.1 million in 2005 to 8.7 million people with PD by 2030.
About Titan Pharmaceuticals
Titan Pharmaceuticals, Inc. (AMEX: TTP) is focused on the late-stage development and commercialization of innovative treatments for central nervous system disorders including schizophrenia, opioid addiction, Parkinson's Disease and chronic pain. Titan has established strategic partnerships with leading pharmaceutical companies, including Vanda and Bayer Schering, to advance some of these programs. 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.
Titan Pharmaceuticals, Inc.
Robert Farrell, 650-244-4990
Executive Vice President & CFO, Titan
Keri P. Mattox, 215-790-0105
Posted: June 2008