Repligen Clinical Investigator Testifies at Congressional Hearings on Autism

Apr 25, 2001, 01:00 ET from Repligen Corporation

    NEEDHAM, Mass., April 25 /PRNewswire/ -- Repligen Corporation
 (Nasdaq: RGEN) noted today the appearance of Dr. Cindy Schneider at
 Congressional hearings on autism research.  The hearings were conducted by the
 House Committee for Reform chaired by Representative Dan Burton (R, IN),
 grandfather of an autistic child.  Dr. Schneider is Co-Medical Director of the
 Southwest Autism Research Center in Phoenix, Arizona, one of five clinical
 sites in Repligen's Phase 2 clinical trial of secretin for autism.
     In her testimony Dr. Schneider stated: "Three doses of secretin produced a
 significant decrease in the symptoms of autism in 42% of children in the
 treatment group, while 27% in the placebo group improved as measured by the
 parental Clinical Global Impression scale, with a p value of 0.02."
 
     (Click here for an excerpt from Dr. Schneider's written statement for the
 record of the Congressional hearings on autism.)
 http://www.repligen.com/News/PressReleases/pr010425.html
 
     Dr. Schneider noted the principal accomplishments of the Phase 2 trial:
 
     1. The activity of secretin in young children with gastrointestinal
 symptoms was observed with a parental assessment of global change in symptoms.
 
     2. A biological marker was identified which identified a subset of
 patients in whom the ability to measure the effects of secretin was improved.
 The use of this marker may improve the ability to demonstrate the effects of
 secretin in future trials.
 
     3. No serious "adverse events" were observed in any patient and the number
 of  "adverse events" related to behaviors associated with the symptoms of
 autism (hyperactivity, aggressiveness, or agitation) were equal in the
 secretin and placebo-treated groups.
 
     4. The sensitivity of several symptom assessment tools to changes in the
 symptoms of autism was established and several tools were identified which may
 be useful in future trials.
 
     "We are pleased that these hearings are increasing the awareness that
 there is an urgent need to accelerate biological research in autism," stated
 Walter Herlihy, President and CEO of Repligen.  "We believe that our clinical
 trial will provide new discoveries on the biology of autism and ways to
 improve the design and execution of future trials of any potential new
 therapy."
 
     The Phase 2 clinical trial of secretin enrolled 136 children 3 to 6 years
 of age at five U.S. clinical centers: the Southwest Autism Research
 Center/Phoenix Children's Hospital (Phoenix, AZ), the Rochester Institute for
 Digestive Diseases and Sciences (Rochester, NY), the University of Maryland
 Medical Center (Baltimore, MD), the Mayo Clinic (Rochester, MN) and the MIND
 Institute/University of California, Davis (Sacramento, CA).
 
     Repligen Corporation develops new drugs for debilitating pediatric
 diseases including autism, cancer, and immune and metabolic disorders.
 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 timelines for clinical activity, required
 regulatory approvals, 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.
 
                     MAKE YOUR OPINION COUNT -  Click Here
                http://tbutton.prnewswire.com/prn/11690X32327842
 
 

SOURCE Repligen Corporation
    NEEDHAM, Mass., April 25 /PRNewswire/ -- Repligen Corporation
 (Nasdaq: RGEN) noted today the appearance of Dr. Cindy Schneider at
 Congressional hearings on autism research.  The hearings were conducted by the
 House Committee for Reform chaired by Representative Dan Burton (R, IN),
 grandfather of an autistic child.  Dr. Schneider is Co-Medical Director of the
 Southwest Autism Research Center in Phoenix, Arizona, one of five clinical
 sites in Repligen's Phase 2 clinical trial of secretin for autism.
     In her testimony Dr. Schneider stated: "Three doses of secretin produced a
 significant decrease in the symptoms of autism in 42% of children in the
 treatment group, while 27% in the placebo group improved as measured by the
 parental Clinical Global Impression scale, with a p value of 0.02."
 
     (Click here for an excerpt from Dr. Schneider's written statement for the
 record of the Congressional hearings on autism.)
 http://www.repligen.com/News/PressReleases/pr010425.html
 
     Dr. Schneider noted the principal accomplishments of the Phase 2 trial:
 
     1. The activity of secretin in young children with gastrointestinal
 symptoms was observed with a parental assessment of global change in symptoms.
 
     2. A biological marker was identified which identified a subset of
 patients in whom the ability to measure the effects of secretin was improved.
 The use of this marker may improve the ability to demonstrate the effects of
 secretin in future trials.
 
     3. No serious "adverse events" were observed in any patient and the number
 of  "adverse events" related to behaviors associated with the symptoms of
 autism (hyperactivity, aggressiveness, or agitation) were equal in the
 secretin and placebo-treated groups.
 
     4. The sensitivity of several symptom assessment tools to changes in the
 symptoms of autism was established and several tools were identified which may
 be useful in future trials.
 
     "We are pleased that these hearings are increasing the awareness that
 there is an urgent need to accelerate biological research in autism," stated
 Walter Herlihy, President and CEO of Repligen.  "We believe that our clinical
 trial will provide new discoveries on the biology of autism and ways to
 improve the design and execution of future trials of any potential new
 therapy."
 
     The Phase 2 clinical trial of secretin enrolled 136 children 3 to 6 years
 of age at five U.S. clinical centers: the Southwest Autism Research
 Center/Phoenix Children's Hospital (Phoenix, AZ), the Rochester Institute for
 Digestive Diseases and Sciences (Rochester, NY), the University of Maryland
 Medical Center (Baltimore, MD), the Mayo Clinic (Rochester, MN) and the MIND
 Institute/University of California, Davis (Sacramento, CA).
 
     Repligen Corporation develops new drugs for debilitating pediatric
 diseases including autism, cancer, and immune and metabolic disorders.
 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 timelines for clinical activity, required
 regulatory approvals, 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.
 
                     MAKE YOUR OPINION COUNT -  Click Here
                http://tbutton.prnewswire.com/prn/11690X32327842
 
 SOURCE  Repligen Corporation