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Repligen Initiates Clinical Trial of Secretin in Obsessive-Compulsive Disorder
Friday September 24, 11:15 am ET
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.
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"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.
About Repligen Corporation
Repligen Corporation is a biopharmaceutical company committed to being the leader in the development of novel therapeutics for profound neuropsychiatric disorders and autoimmune disease with particular emphasis on applications for children. Repligen has a Specialty Pharmaceuticals business comprised of rProtein A(TM) and SecreFlo(TM), the profits from which will be used to partially support the development of our proprietary products. Repligen's corporate headquarters are located at 41 Seyon Street, Building #1, Suite 100, Waltham, MA 02453. Additional information may be requested from http://www.repligen.com.
This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements in this press release do not constitute guarantees of future performance. Investors are cautioned that statements in this press release which are not strictly historical statements, including, without limitation, statements regarding current or future financial performance, management's strategy, plans and objectives for future operations, clinical trials and results, litigation strategy, product research, intellectual property, development and manufacturing plans, constitute forward-looking statements. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including, without limitation, risks associated with: the success of current and future collaborative relationships, the success of our clinical trials and our ability to develop and commercialize products, our ability to obtain required regulatory approvals, our compliance with all Food and Drug Administration regulations, our ability to obtain, maintain and protect intellectual property rights for our products, the risk of current and future litigation regarding our patent and other intellectual property rights, the risk of litigation with collaborative partners, our limited sales and marketing experience and capabilities, our limited manufacturing capabilities and our dependence on third-party manufacturers and value-added resellers, the market acceptance of our products, our ability to compete with larger, better financed pharmaceutical and biotechnology companies that may develop new approaches to the treatment of our targeted diseases, our history of losses and expectation of incurring continued losses, our ability to generate future revenues, our ability to raise additional capital to continue our drug development programs, and other risks detailed in Repligen's filings with the Securities and Exchange Commission. Repligen assumes no obligation to update any forward- looking information contained in this press release or with respect to the announcements described herein.
Lisaks veel: Repligen Corporation Financials
http://finance.yahoo.com/q/is?s=rgen
