Titan Pharmaceuticals Announces Spheramine(R) Presentation at 76th Annual American Association of Neurological Surgeons (AANS) Meeting
The pilot study was conducted at Emory University Hospital to evaluate the safety, tolerability and preliminary efficacy of Spheramine and included six patients with moderate to advanced Parkinson's disease. Study results will be discussed during a presentation titled "Intrastriatal Implantation of Human Retinal Pigment Epithelial (hRPE) Cells Attached to Gelatin Microcarriers (GM) for the Treatment of Parkinson's Disease (PD)." This presentation is scheduled to be given at the AANS meeting by Roy A. E. Bakay, M.D. on Tuesday, April 29.
In this pilot study, Spheramine was administered in the most affected side of the patient's brain using a needle and MRI guidance. The study's primary efficacy measure was the improvement in the motor score of the Unified Parkinson's disease Rating Scale (UPDRS). Secondary efficacy variables included patient-reported quality of life measures. Results of the study show that:
-- Long-term improvement of symptoms was demonstrated and, importantly, significant clinical improvements were noted in mobility - an average of 44 percent improvement from baseline at 48 months in UPDRS motor scores.
-- Significant clinical improvements were seen in patient-reported quality of life scores - 23 percent improvement from baseline at 48 months
-- There were no Spheramine-related serious adverse events reported
-- The most frequent adverse event was post-surgical headache, which spontaneously resolved within 1-2 weeks for all patients.
Based on the positive one-year results seen in the 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 in third quarter of 2008. The design of this study also will be discussed at the AANS meeting during a separate session. A discussion titled "The STEPS Trial: Design of a Phase 2 Study to Evaluate Spheramine(R), A Novel Cell-Based Therapy Administered by Stereotactic Implantation into the Striata of Patients with Parkinson's Disease (PD)" will be presented by Robert E. Gross, M.D. also on Tuesday, April 29.
"We are very encouraged by these continued positive results, and of the promise of Spheramine in treating moderate to advanced Parkinson's patients - a patient population in need of safe and effective treatments that will remain effective over the long-term," said Marc Rubin, M.D., President and CEO of Titan. "We expect to have results of our ongoing Phase IIb trial in the third quarter of this year and look forward to important progress with this program."
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.
Robert Farrell, Executive Vice President & CFO
Keri P. Mattox, 215-790-0105
Posted: April 2008