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Biotech / Medical : Stressgen (VSE: SSB)
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To: David Culver who wrote (224)2/26/2004 5:36:42 PM
From: Heat Shock  Read Replies (1) of 236
 
David,

The results in two trials were reported.

The RRP (recurrent respiratory papillomatosis) PII trial results are excellent and support going ahead with PIII for that indication.) Stressgen has both orphan drug status and fast track status for RRP. The GENZ-like strategy of going for low volume, orphan drug, high price indications is very enticing.

It's too bad that in the second of the two trials reported, AIN PII, the treatment did no better than placebo. The placebo rate was twice the placebo rate in the previous trial- 45%, I think it was. Wow. The high discordance rate of the pathologists reading of the HPV lesions was unfortunate also. Discordance is when 2 pathologists differ in their judgement of whether the lesion is high grade (worse) or low grade (better). The conference call pointed out that historically, the discordance rate is much greater when the pathologists are judging the lower grades. That's tough when a trial end point relies on them finding lower grade lesions.

The conference call also pointed out that placebo effects are much less likely in RRP. The end point of lengthening of time between surgeries is not as subject to surprises.

All of several findings on the RRP PII trial were positive and statistically significant. RRP is StressGen's first indication to market.

Heat.
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