background info for Reuters letter writing campaign

[Guest guest]

Several folks have written me privately to say that they want to help out,

but don't have access to the Reuters report. Please find both the negative

Reuters and the positive Dow coverage of the Repligen Phase 2 trial

results below. I've included a copy of my own letter for your convenience.

Please " bcc " me when you write... or send by separate cover as it's very good

to know if/how the community is responding!

Thanks to all, LeGendre

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

Is the glass half full or half empty? What happened to the parent's opinion

in the Reuters interpretation? I guess they don't count?!! One of the many

important lessons learned from this trial is that current autism diagnostic

tools (CARS was designed to diagnose autism) are inadequate for assessing

change over the time course of a clinical drug trial. LeGendre

PS. We STILL believe that the glass is half full!

Wednesday April 4, 11:29 am Eastern Time

" Repligen says autism drug misses main goal "

NEW YORK, April 4 (Reuters) - Repligen Corp. (NasdaqNM:RGEN - news) on

Wednesday said its experimental treatment for autism failed to meet its

primary goal in a Phase II trial of children with moderate to severe symptoms

of the condition, sending shares falling.

Stock of the Needham, Mass.-based biotech firm fell 72 cents, or about 25

percent, to $1.94 on Nasdaq after the company reported initial results of the

U.S. study.

Autism is a condition in which a child is unable to develop normal social

relationships, behaves compulsively and usually fails to develop normal

intelligence. The cause of autism is unknown, but it is believed to have a

genetic link.

Repligen said its study involved children aged 3 to 6, with 66 receiving its

drug -- human synthetic secretin -- and 60 receiving a placebo.

The primary goal of the trial was to see how patients scored on a standard

evaluation called the Childhood Autism Rating Scale, which helps diagnose the

condition. Repligen said score changes in the children taking its drug ``were

not significantly different compared to the placebo group.''

Although failing to achieve its primary goal, the company said favorable

trends were seen in a subset of autistic children taking secretin. The

company said there were no serious adverse side effects seen in either of the

patient groups.

Repligen said it planned to present detailed results from the Phase II trial

at future scientific meetings. Moreover, it said data from the trial would

help the firm plan additional clinical trials ``with far greater precision

than previously possible.''

Repligen: Initial Secretin Phase 2 Results Positive

Dow Newswires

NEEDHAM, Mass. -- Repligen Corp. (RGEN) said initial results from a Phase 2

clinical trial of human synthetic secretin in young children with autism

indicate the drug produced a statistically significant improvement in autism

symptoms.

In a press release Wednesday, the company said the double-blind, randomized,

placebo-controlled trial evaluated the safety and efficacy of three

administrations of secretin or a placebo at three-week intervals in autistic

children.

The trial enrolled 136 children three to six years of age at five U.S.

clinical centers, Repligen said. The children who participated had moderate

to severe symptoms of autism and reported gastrointestinal symptoms. There

were 66 evaluable patients in the secretin group and 60 in the placebo group.

The company said the study showed that three doses of secretin produces a

statistically significant clinical response in a subset of autistic children.

The trial also indicates that in this patient population parental

observations over eight weeks were more sensitive to change than observations

based on a clinical visit.

The study also evaluated the safety of secretin, showing no " serious adverse

events " in either the secretin or placebo-treated groups.

Repliben said the data obtained in this trial will enable the company to plan

and execute additional clinical trials in this patient population with far

greater precision than previously possible.

The company expects to complete additional analysis of the Phase 2 data as

quickly as possible, and to discuss the future development program with the

Food and Drug Administration.

Repligen develops new drugs for pediatric diseases including autism, cancer,

and immune and metabolic disorders. The company also makes and markets

patented products based on Protein A, which are used by the pharmaceutical

industry to produce therapeutic antibodies.

Company Web site: http://www.repligen.com

To: .Howell@... and .Luxenberg@...

RE: Repligen Phase 2 trial on Secretin in Autism

Dear Mr. Howell and Mr. Luxenberg;

Is the glass half full or half empty? My glass WAS half full before Reuters

stepped in.

What happened to the parent's rating (p = 0.02) in the Reuters interpretation

of the Repligen Phase 2 trial in autism? What about secretin's perfect

safety record or the professional rater's CGI report (p = 0.06)? Your spin

on these trial results (negative, negative, negative) is one of the more

extreme examples of sloppy reporting and/or gross misinterpretation of

clinical trial findings that I have ever witnessed.

Your report has stunned all of us in the autism community.

If you think that parent's opinion should not matter in this trial, you

should spend a few days living with a family with an autistic spectrum child.

Or better, find a family with two or more affected children; it is NOT

difficult to find such families.

One of the many important lessons learned from this trial is that current

autism diagnostic tools (CARS was designed to DIAGNOSE autism) are inadequate

for assessing change in autistic symptomology over the time course of a

clinical drug trial. By clearly articulating the problem, Repligen has

already put the first foot forward in ameliorating this deficit for future

clinical trials in this population. Of course, your sloppy and malicious

reporting may have stopped this effort short.

Sincerely,

LeGendre, Ph.D. (NLeGendre@...)

Mother to 2 Autistic Spectrum daughters