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Clinical Trial of Secretin Initiated in Obsessive-Compulsive Disorder

WALTHAM, Mass., Sept. 24 /PRNewswire-FirstCall/ -- Repligen Corporation (Nasdaq: RGEN - News) announced today that it has initiated a Phase 1 clinical trial to evaluate RG1068, synthetic human secretin, in patients with obsessive- compulsive disorder (OCD). This trial will evaluate two dose levels of a subcutaneous formulation of RG1068, administered three times a week for one month. This open-label, dose escalation, study will enroll up to sixteen patients with OCD and will evaluate the safety, tolerability and potential impact of RG1068 on the symptoms of OCD including obsessive thoughts and compulsive behaviors. Repligen is currently conducting a Phase 2 clinical trial of RG1068 in patients with refractory schizophrenia.

"The objective of this trial is to assess the safety, tolerability and potential efficacy of RG1068 in patients with OCD," stated Walter C. Herlihy, President and Chief Executive Officer of Repligen. "It will also allow us to confirm the safety and bioavailability of our subcutaneous formulation of RG1068."

This Phase 1 trial is based on preclinical results, published in Psychopharmacology, that demonstrated that secretin is active in a well- recognized animal model of anxiety. These data are consistent with the discovery that secretin activates the amygdala, a brain region identified as the center of the fear and anxiety response. The subjects in the Phase 1 study will be outpatients with a DSM-IV diagnosis of OCD with moderate to severe symptoms, aged 18 to 40 years old. Patients will be evaluated with standardized instruments for the assessment of the symptoms of OCD and the Clinical Global Impression of Change. The subcutaneous formulation of RG1068 has been evaluated in a clinical trial of healthy volunteers that established the subcutaneous dose of secretin that is necessary to achieve the equivalent blood levels that are achieved when administered by intravenous injection. Subcutaneous dosing has the potential advantage of being administered in the home or in a community-based setting.

About Obsessive-Compulsive Disorder
Anxiety disorders are serious medical illnesses that affect approximately 20 million adults in the United States. These disorders include generalized anxiety disorder, social anxiety disorder, post traumatic stress disorder, panic disorder and obsessive-compulsive disorder. Obsessive-compulsive disorder affects approximately 3.3 million adults in the United States, causing patients to experience obsessive thoughts and perform repetitive rituals (e.g. checking, hoarding, hand washing) that interfere with normal life. The obsessive thoughts and compulsions are often irrational and cause significant stress and anxiety, leading to isolation of the individual from work or society, or impaired productivity. Individuals with OCD often recognize their behaviors as excessive or unreasonable. OCD is a chronic condition that usually begins in adolescence or early adulthood. Although patients can be treated with cognitive behavioral therapy and conventional antidepressant or antianxiety drugs, approximately 20% of patients achieve full remission. Secretin may provide an alternative for patients who are refractory to other drug therapies.

Source: Repligen Corporation

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