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Repligen Announces Plans to Initiate a Phase 2b Trial for RG2417 in Bipolar Disorder
Date:6/12/2008

bo (p<0.001), compared to all patients in the study receiving RG2417 who had an average improvement on MADRS of 3.0 points over placebo (p=0.01) as previously reported. This result may reflect the difficulty in accurately diagnosing bipolar disorder in the absence of frequent symptomatology and will be used in the design and execution of the next study.

"The safety and efficacy results of our previous study of RG2417 strongly support further evaluation in patients with bipolar disorder," stated Walter C. Herlihy, President and Chief Executive Officer of Repligen Corporation. "We are very pleased to have someone with Gary's expertise to lead the next phase of our clinical development program."

The previously reported Phase 2a study was a multi-center study in which 83 patients received either RG2417 or a placebo twice a day for six-weeks. Patients in the RG2417 and placebo groups were well matched in their symptoms at baseline with the exception of mania for which the RG2417 group mania score was significantly higher (p=0.01). The objective of the study was to assess the safety and efficacy of RG2417 on the symptoms of bipolar depression as measured by the co-primary endpoints, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Clinical Global Impression of Change in Bipolar Disorder scale (CGI-BP-C). Patients were evaluated at baseline and then weekly using these standardized tools to assess change in their symptoms. Over the six-week treatment period, the study demonstrated a statistically significant improvement in the symptoms of depression in the patients receiving RG2417 when compared to placebo on the MADRS (p=0.01) and on the CGI-BP-C (p=0.044).

A complete review of the data suggests that RG2417 was well tolerated. This study was conducted under a development agreement with the Stanley Medical Research Institute, the largest nonprofit provider of funding for research on schizophrenia and bipolar disorder in the United States. <
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