To: Cheryl Galt who wrote (199 ) 3/29/2000 6:57:00 PM From: LLCF Read Replies (2) | Respond to of 395
Phase2 for autism, glad to see the patient ages here vs the other studies: Wednesday March 29, 6:59 am Eastern Time Company Press Release SOURCE: Repligen Corporation Repligen Initiates Phase II Trial of Secretin Largest Clinical Trial in Autism to Be Conducted at Four U.S. Sites NEEDHAM, Mass., March 29 /PRNewswire/ -- Repligen Corporation (Nasdaq: RGEN - news) today announced it has initiated a Phase II clinical trial with the hormone secretin in children with autism. The double-blind, placebo- controlled study will involve up to 140 autistic children aged 3 to 6. After extensive documentation of their autistic and gastrointestinal symptoms, each patient will receive three treatments and a thorough follow-up evaluation over a 10-week period. The primary objective of the study is to determine if secretin improves the social and communicative deficits of autism. These symptom changes will be evaluated with multiple assessment tools including video taping of structured play sessions, clinical and parent evaluations using accepted tools and a daily diary of symptoms. A secondary objective is to assess changes in the patients' gastrointestinal symptoms following treatment. The trial will include an endoscopic examination of the gastrointestinal tract for patients for whom this evaluation is deemed appropriate. The Phase II trial sites will include the Mayo Clinic, the University of Rochester Medical Center and the Southwest Autism Research Center in collaboration with Phoenix Children's Hospital. The study is expected to be completed by year's end. Repligen has also initiated a significant research effort to better understand the biology of secretin and its mechanism of action in autistic patients. Analysis of patient samples to date has demonstrated physiological changes in some children treated with secretin. Similar analyses will be conducted on patients enrolled in the clinical trial which will be correlated with changes in autism symptomatology. ``We believe this to be the largest and most comprehensive clinical trial ever carried out in autism,' commented Walter C. Herlihy, Ph.D., President and CEO of Repligen. ``By correlating changes in physiology with changes in the symptoms of autism, we hope to define the biological characteristics associated with response to secretin.' Secretin is currently approved by the FDA to diagnose gastrinoma and assess pancreatic function. Anecdotal reports from ``off-label' use of secretin in pediatric autism suggest that it may improve both physiological and behavioral symptoms associated with autism, a disorder characterized by severely impaired communication, social skills and development. There are no drugs currently approved for the treatment of autism. Repligen Corporation develops new drugs for autism, organ transplant and cancer. Repligen also manufactures and markets a set of patented products based on Protein A which are used by the pharmaceutical industry to produce therapeutic antibodies. Its corporate headquarters are located at 117 Fourth Avenue, Needham, MA 02494. Additional information may be requested from www.repligen.com. This press release contains forward-looking statements based on current management expectations. There are certain key factors which could cause future results to differ materially from those anticipated by management. Such factors include, but are not limited to: uncertainty in the realization of future revenues, the uncertain timeline for clinical activity, results of pending or future clinical trials, the Company's ability to continue to establish collaborative arrangements with third parties; the Company's ability to maintain financial stability; the technical risks associated with development and manufacture of clinical products; the fact that there can be no assurances that patents relating to the Company's potential products will afford adequate protection to the Company, the risks of technological change and competition, and the competitive environment of the biotechnology and pharmaceutical industries. These factors are more fully discussed in the Company's periodic filings with the Securities and Exchange Commission. SOURCE: Repligen Corporation DAK