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Repligen Starts Phase II of Largest Secretin Trial / Irish Times Letter / DC Aut Radio

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FEAT DAILY NEWSLETTER Sacramento, California http://www.feat.org

" Healing Autism: No Finer a Cause on the Planet "

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Repligen Starts Phase II of “Largest” Secretin Trial / Irish Times Letter /

DC Aut Radio

[secretin trials largest clinical trial in autism to be conducted at four US

sites. From a company press release.]

http://www.repligen.com

Repligen Corporation announced last week 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.

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Letter on MMR/Vaccinations: The Irish Times

http://www.ireland.com/newspaper/letters/2000/0404/index.htm#6

Sir, - Niall Dollard (March 25th) is incorrect on several issues

regarding MMR vaccination. DTP is a triple component vaccine just like MMR.

There is absolutely no evidence linking wild measles, mumps or rubella virus

to autism. The dilute, weakened measles, mumps and rubella vaccine viruses

do not cause autism. The temporal association between the administration of

MMR vaccine in the second year of life and the onset of autism at this time

in no way proves cause an effect.

Autism is a very profound disorder with a strong genetic component. Mr

Dollard should read the February 2000 issue of Scientific American, which

carries an important article on the origins of autism. - Yours, etc.,

Denis G. Gill Professor of Paediatrics Royal College of Surgeons in

Ireland, St 's Green, Dublin 2.

* * *

DC Radio on Autism Tomorrow

Wednesday, WAMU/NPR 88.5 FM will have the following on the Diane Rehm show

at 10:00 am:

http://www.wamu.org/drhi.html

Autism is the name given to a group of related, complex developmental

disorders that typically affect communication and social interaction skills.

Diane and her guests discuss the latest research being done into the causes

of and treatments for autism, and talk about the challenges faced by

families of autistic children *** WHY YOU MAY WANT TO

**********************************************

Rally for National Autism Awareness

April 8, 2000

Open Your Eyes to Autism & Hear~Their~Silence

www.littleangels.org www.ark-inc.org

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Editor: Lenny Schafer | Eastern Editor: | News Wire: Ron Sleith

schafer@... | PhD |

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