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To: Richard Huth who wrote (1397)10/13/1998 9:03:00 AM
From: NeuroInvestment  Read Replies (1) | Respond to of 1491
 
FWIW, I was sufficiently concerned by what I feel was the excessively gloomy slant taken by BioCentury (a publication that I respect and enjoy greatly) that I contacted David Flores and Ilan Zipkin (the publisher and writer respectively). Regarding the points abstracted here from the article:
1)the article implied that previous PhII studies were equally appealing, only to collapse in PhIII. In fact, the studies tended to be smaller and not as well constructed (e.g. the Cambridge Neuroscience Cerestat PhII involved 38 pts, no control group, no statistical analysis possible...the first Cortech PhII involved 20 pts in a single hospital in Africa...). By comparison the PARS study was much more rigorously constructed and carried out; the results thus deserve more credence than those earlier studies.
2)the comment by Mr. Huth suggests that one less placebo death would have left the drug group with more deaths--not true, it was 5/3. I would agree that the small n, and the infrequent incidence of death, makes this a highly unstable measure in this study.
3) The BioCentury article quoted the press release regarding 'no difference in the highest outcome groups', which referred to the lack of difference between drug and placebo when it comes to the proportion falling into the good outcome and mild disability categories, the two GOS categories lumped together. It made no mention of the three month figures, the 6 month 45-37% contrast for the highest 'good outcome' category, nor did it mention the 38-13% contrast for the severely injured subgroup. To me, it seemed a selective reporting of results that was excessively negative. After all, the PARS release mentioned the lack of contrast using the two category criterion only to avoid appearing excessively positive.

Big Pharma suitors will not be swayed by the tenor of the BioCentury article, so ultimately it matters little. But it was unfortunate that even a normally astute observer of the biotech scene could end up viewing this study through a skeptical lens so darkened by the legacy of other companies failures, failures from which Pharmos tried very hard to learn and improve in the design of this trial. NeuroInvestment (www.neuroinv.com)



To: Richard Huth who wrote (1397)10/13/1998 12:45:00 PM
From: yosi s  Read Replies (1) | Respond to of 1491
 
I would like to point out that in Phase 2 study in all groups hu211
showed improvement. However it was much more distinct in the more severe group.

Let me explain why I feel it is important.

In the more severe group there is a greater injury thus more chance for hu 211 to show its effectiveness.

In the less afflicted group even doing nothing some people will recover eventually. so it is harder to show that medication is effective, but hu211 sped up recovery. so it is working, they just need a bigger study.
Let me eleborate. If you get the common cold it is disabling but it will resolve no matter the treatment. but a medication is effective it it will help you get over your cold sooner.

Same here in 3 month you could see those that gotten better sooner.

What is important is the study design of phase3 to show significance difference in faster healing in the group that were to get better anyway. and more healing in the severe group.. numbers that are seen in phase 2.