Repligen Announces Open Label Extension of Phase 3 Clinical Trials of Synthetic Human Secretin in Children with Autism

25 марта, 2003
WALTHAM, Mass., March 25 /PRNewswire-FirstCall/ -- Repligen Corporation announced today plans to initiate an open label extension of its ongoing Phase 3 clinical trials of synthetic human secretin in children with autism. PR via NewsEdge Corporation : WALTHAM, Mass., March 25 /PRNewswire-FirstCall/ -- Repligen Corporation (Nasdaq: RGEN) announced today plans to initiate an open label extension of its ongoing Phase 3 clinical trials of synthetic human secretin (RG1068) in children with autism. In the extension phase of the study, all patients who complete the Phase 3 trials will be offered the option of treatment with RG1068 once every three weeks for 1 year. The goal of the Phase 3 Extension Study is to provide patients access to RG1068 and to collect additional, longer-term safety data. Each patient will be monitored for Adverse Events and changes in a variety of blood parameters throughout the Extension Study. "We are pleased to receive approval from the FDA for this open label extension of our Phase 3 clinical trials which was initiated at the request of some of the clinical investigators in our study," stated Walter C. Herlihy, President and CEO of Repligen. "This study will provide patients, including those who may have received the placebo in the Phase 3 study, access to RG1068 prior to the completion of the Phase 3 study." Data from the Phase 3 Extension Study will add to the extensive safety data already collected in the Phase 2 clinical trial, the Phase 2 Extension Study and the on-going Phase 3 clinical trials. To date there have been more than 1,000 administrations of RG1068 in children with autism without a serious adverse event. Extensive analyses of blood and urine chemistries have shown no indication of toxicity associated with administration of RG1068 and no patient has developed an antibody response to RG1068. About Repligen's Phase 3 Clinical Trial of RG1068 Repligen is currently enrolling children aged 2 years 8 months to 4 years 11 months with moderate to severe symptoms of autism into two Phase 3 clinical trials. Each patient is comprehensively evaluated at baseline, receives six injections of RG1068 or a placebo over 18 weeks, and is then reevaluated for improvements in the symptoms of autism. The primary endpoints for the trial are improvements in reciprocal social interaction as measured with the Autism Diagnostic Observation Schedule and the Clinical Global Impression of Change. Secondary endpoints include improvements in language and improvements in behavior. The trials are currently being carried out at approximately 20 medical centers in the United States. Information concerning participation in the Phase 3 clinical trials may be found on www.autismtrial.com. About Repligen Corporation Repligen Corporation is a biopharmaceutical company committed to being the leader in the development of new drugs for pediatric developmental disorders including autism, immune and metabolic disorders. Repligen has a Specialty Pharmaceuticals business comprised of rProtein A(tm) and SecreFlo(tm), the profits from which will be used to support the development of our proprietary products. rProtein A(tm) is a consumable reagent used by the pharmaceutical industry to produce a class of drugs called monoclonal antibodies and SecreFlo(tm), secretin for injection, is marketed to gastroenterologists for pancreatic assessment and for use during a gastrointestinal procedure called ERCP. Repligen's corporate headquarters are located at 41 Seyon Street, Building #1, Suite 100, Waltham, MA 02453. Additional information may be requested from www.repligen.com. This release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934. The forward-looking statements in this 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 and product plans and performance such as the anticipated growth in the monoclonal antibody market and projected growth in product sales, 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 market acceptance of our products, our ability to compete with larger, better financed pharmaceutical and biotechnology companies, new approaches to the treatment of our targeted diseases, our expectation of incurring continued losses, our uncertainty of product revenues and profits, our ability to generate future revenues, our ability to raise additional capital to continue our drug development programs, the success of our clinical trials, 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 litigation regarding our intellectual property rights, our limited sales and manufacturing capabilities, our dependence on third-party manufacturers and value added resellers, our ability to hire and retain skilled personnel, our volatile stock price, 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. Walter C. Herlihy, Ph.D. President and Chief Executive Officer (781) 250-0111, ext. 2000 David Walsey EURO RSCG Life NRP (212) 845-4257 SOURCE Repligen Corporation -0- 03/25/2003 /CONTACT: Walter C. Herlihy, Ph.D., President and Chief Executive Officer of Repligen, +1-781-250-0111, ext. 2000; or David Walsey of EURO RSCG Life NRP, +1-212-845-4257/ /Web site: http://www.repligen.com/ (RGEN) CO: Repligen Corporation ST: Massachusetts IN: MTC BIO SU: EO-CR -- NETU005 -- 0765 03/25/2003 07:59 EST http://www.prnewswire.com <> << Copyright ©2003 PR Newswire >>
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