Titan/Bayer Schering's Parkinson's candidate did not meet endpoint

The USA's Titan Pharmaceuticals says that Spheramine, its novel cell-based therapy for the treatment of moderate-to-advanced Parkinson's disease developed with Germany's Bayer Schering, has failed to meet its primary or key secondary endpoints in a Phase IIb clinical study.

The STEPS trial was a multicenter, double-blind, randomized, sham surgery-controlled, study testing the safety, tolerability and efficacy of Spheramine. The results showed no significant differences between the therapy and placebo after 12 months of follow-up.

"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," said Marc Rubin, chief executive of Titan. "We are highly committed to our two later-stage programs, iloperidone and probuphine, both of which have key upcoming milestones with a PDUFA date for iloperidone in late July, and probuphine Phase III trial results expected in the third quarter of this year," he added.