"We are pleased to have advanced our pipeline programs this quarter, and we expect to receive pivotal data from both our Phase 3 pancreatic imaging and Phase 2b bipolar depression studies in 2010," stated Walter C. Herlihy, President and Chief Executive Officer of Repligen Corporation. "Our financial resources will allow us to continue to pursue our goal to build a sustainable biopharmaceutical company by developing innovative products that have the potential to markedly improve patients' lives."
RG1068 for Imaging of the Pancreas
We are currently enrolling patients in a Phase 3 clinical trial of RG1068, synthetic human secretin, designed to assess the ability of RG1068 in combination with magnetic resonance imaging (MRI) to improve the detection of pancreatic duct abnormalities compared to MRI alone. Detailed visual assessment of the pancreatic ducts is important in the diagnosis and treatment of diseases such as acute and chronic pancreatitis. This study is being conducted at approximately 30 clinical sites within the U.S. and Canada and will enroll approximately 225 patients. We have made steady progress on enrollment and plan to complete this trial by the end of the year. The FDA has granted this program Fast Track Designation, a process designed to facilitate the development and expedite the review of drugs that treat serious diseases and fill an unmet medical need. There are more than 300,000 MRI procedures conducted in the U.S. and Europe each year that could benefit from the use of RG1068.
RG2417 for Bipolar Disorder
We are currently enrolling a Phase 2b clinical trial of RG2417, an oral formulation of uridine, in patients with bipolar depression. This is a multi-center, randomized, double-blind, placebo-controlled clinical trial in which approximately 150 patients with bipolar depressi
|SOURCE Repligen Corporation|
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