Titan Pharmaceuticals (TTP) Announces Spheramine Presentation as AANS

April 28, 2008 10:39 AM EDT

Titan Pharmaceuticals, Inc. (AMEX: TTP) announced that four-year follow-up data from an open label pilot study of Spheramine, its novel cell therapy product being developed in collaboration with Bayer Schering Pharma AG for the treatment of moderate to advanced Parkinson's disease, will be presented at the 76th Annual Meeting of the American Association of Neurological Surgeons (AANS) in Chicago.

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.

"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."

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