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Biotech / Medical : Repligen Corp (RGEN) -- Ignore unavailable to you. Want to Upgrade?

To: Curtis E. Bemis who wrote (181)	11/11/1999 9:05:00 AM
From: Curtis E. Bemis	Read Replies (1) \| Respond to of 395

And, Repligens News release--today Enhanced Response to Secretin in Autistic Children with Gastrointestinal Dysfunction Reported in Journal of Pediatrics PR Newswire - November 11, 1999 08:45 Repligen and University of Maryland Sign Research Agreement NEEDHAM, Mass., Nov. 11 /PRNewswire/ -- Repligen Corporation (Nasdaq: RGEN) today announced findings from a paper published in the November issue of the Journal of Pediatrics where researchers from the University of Maryland School of Medicine documented a series of gastrointestinal abnormalities in autistic children. It is one of few studies to specifically address gastrointestinal problems in autism patients, and the first published report to document effects of the hormone secretin when administered to autistic children. "Unrecognized gastrointestinal disorders may contribute to the behavioral problems of the non-verbal autistic patients," the study paper concluded. "Further studies are required to determine the possible association between the brain and gastrointestinal dysfunctions in children with autistic disorder." The journal paper described the endoscopic evaluation of 36 autistic children with gastrointestinal symptoms, including the administration of secretin to assess their pancreatic response. Researchers found that 75% of autistic children in the study showed a significantly greater response to secretin compared to children without autism matched by age and gastrointestinal symptoms. The authors suggest that this enhanced response to secretin among the autistic group may be the result of an upregulation of secretin receptors in the pancreas due to the absence of normal secretin stimulation. The journal study noted that children with chronic diarrhea who demonstrated a hypersensitive response to secretin also had improved stool consistency that was either sustained or lasted for at least a few weeks. Two of these children had been previously reported to have significant gastrointestinal and behavioral improvements in autism-associated symptoms following treatment with secretin. An accompanying commentary in the Journal noted that the study "demonstrates consistent physiologic abnormalities ... in autism that are not known to occur in any other specific gastrointestinal disorder. The correlation of these findings with a clinical symptom (chronic diarrhea) and its response to secretin administration provide further support for a true physiologic abnormality." Repligen, which owns patent applications for the development of secretin in the treatment of autism, also announced today it has entered into an agreement with the University of Maryland School of Medicine to support further research. The Company is planning FDA approved clinical trials to assess the use of secretin in autism patients. "This study represents the first report of an abnormal physiological response to secretin in pediatric autism and may define a subset of children for whom clinical evaluation of secretin for improvements in autistic symptoms is particularly warranted," said Walter C. Herlihy, Ph.D., President and CEO of Repligen. "We intend to extend these results through our research collaboration with the University of Maryland and in future clinical trials." The agreement gives Repligen access to extensive research data on the use of secretin based on studies previously conducted by the University. Over the past three years, researchers led by Dr. Karoly Horvath, a pediatric gastrointerologist, have evaluated the effects of secretin in over 70 patients. Repligen will provide the University financial support to continue these studies. In addition to the unusual secretin response, the Journal of Pediatrics study also documented a pattern of intestinal inflammation (esophagitis, gastritis and duodenitis) in a majority of the autistic patients. Examination of intestinal biopsies indicated an increased level of duodenal Paneth (immune) cells consistent with an on-going inflammatory or immune response. None of the 36 children had evidence of infection with H. pylori or fungal or bacterial overgrowth, including 12 patients with suspected yeast infections based on urinary organic acid test results. Secretin is a naturally-occurring hormone that is FDA approved for use in the diagnosis of certain gastrointestinal conditions. In March 1999 Repligen licensed the rights to patent applications for the treatment of autism with secretin. The Company is developing a synthetic human form of secretin for evaluation in clinical trials in pediatric autism. Autism is neurological disorder that typically appears during the first three years of life characterized by defect s in social interaction and communication and abnormal behavior. It is the third most common developmental disability in the U.S. today, and affects at least a half- million people. There is no FDA approved treatment for autism. The University of Maryland School of Medicine is dedicated to providing excellence in biomedical education, clinical research, quality patient care and service to improve the health of the citizens of Maryland. 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 /CONTACT: Walter C. Herlihy, Ph.D., President and Chief Executive Officer of Repligen Corporation, 781-449-9560, ext. 2000 or Brad Miles of BMC Communications, 212-477-9007, ext. 17/ /Web site: repligen.com