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news.Titan Pharmaceuticals has announced that initial analyses show that Spheramine did not meet the Phase IIb clinical study's primary or key secondary endpoints, with no significant differences detected between the Spheramine and sham surgery arms of the study after 12 months of follow-up.
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The Phase IIb trial was designed to explore the safety, tolerability and efficacy of Spheramine, the company’s novel cell-based therapy for the potential treatment of moderate to advanced Parkinson’s disease.
Marc Rubin, president and CEO of Titan, said: “We are disappointed by these data as we have been diligently working to address the critical unmet medical need facing Parkinson’s patients. Although we do not expect our partner Bayer Schering Pharma to continue development of this product, we will continue to analyze and assess these data to better understand the study findings and determine our next steps.”