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Secondary observations from the study included a statistically significantdecrease in mania score as determined using the Young Mania Rating Scale(YMRS) for mania (p=0.01), in the patients receiving RG2417 over the aggregatesix-week treatment period when compared to placebo. Preliminary review of thedata suggests that RG2417 was well tolerated. This study was conducted undera development agreement with the Stanley Medical Research Institute, thelargest nonprofit provider of funding for research on schizophrenia andbipolar disorder in the United States.
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"We are pleased with the results of this study which provides substantialevidence of efficacy of RG2417 in improving the symptoms of bipolar disorder,"stated Walter C. Herlihy, President and Chief Executive Officer of RepligenCorporation. "The results of this study support further evaluation of RG2417in this patient population and will be useful in the design of future clinicalstudies."
About Bipolar Disorder
Bipolar disorder, also known as manic depression is an illness marked byextreme changes in mood, thought, energy and behavior in which a person's moodcan alternate between the "poles" of mania and depression. Bipolar disorderaffects more than two million adults in the United States and is usuallydiagnosed in late adolescence or early adulthood. Bipolar disorder is achronic illness associated with substantial morbidity and mortality, rankingworldwide behind only unipolar depression and alcohol abuse among psychiatricillnesses for related disabilities and overall economic burden of illness.The lifetime financial burden of bipolar disorder in the United States isabout $625,000 per patient, depending on resistance to treatment andpersistence of symptoms. Although lithium and anticonvulsants such asvalproic acid have substantially improved the prognosis of bipolar disorder,many individuals are unable to tolerate treatment-related side effects, andincomplete clinical response, relapse, and recurrence remain common clinicalproblems.
About The Stanley Medical Research Institute
The Stanley Medical Research Institute (SMRI) is a nonprofit organizationthat supports research on the causes and treatment of schizophrenia andbipolar disorder (manic-depressive illness), both through work carried out inits own laboratories and through support of researchers worldwide who areworking on these diseases. SMRI is the largest nonprofit provider of researchfunding for schizophrenia and bipolar disorder in the United States and hasprovided over $200 million in funding since 1989.
About Repligen Corporation
Repligen Corporation is a biopharmaceutical company focused on thedevelopment of novel therapeutics for