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Saturday, March 26, 2016 12:26:17 AM
You and biodoc appear concerned about the company decision to target a specific lesion since most psoriasis studies don't do this. And, it appears in conflict with the primary outcome measure of the trial.
Leo's comment follows:
https://www.thelifesciencesreport.com/pub/na/16918?utm_source=delivra&utm_medium=email&utm_campaign=TLSR+final+3-14-16
Nearly all biotechs developing a psoriasis drug target the moderate-to-severe patient class, but not Cellceutix in its Phase 2 study. Ehrlich explained that the company's confidence in Prurisol led to the decision to evaluate the drug under some of the most difficult situations, and that meant a short-duration study evaluating only one particular lesion in patients being treated with an oral drug (Prurisol). "It doesn't get much more difficult than that," Ehrlich said. "But, by going with a short study, we saved money, challenged our drug, and will have plenty of data for a late-stage trial."
https://clinicaltrials.gov/ct2/show/NCT02494479?term=prurisol&rank=2
Primary Outcome Measures:
• The primary efficacy endpoint will be the percentage of subjects with ≥ 2 point improvement in IGA rating as defined by visual inspections of patient lesions [ Time Frame: 84 days ] [ Designated as safety issue: No ]
In looking back at the trial again and going beyond just the primary outcome I see the single lesion test in the secondary outcome measures. I don't believe this focus invalidates or takes away from the primary measure. I just think Leo was focusing on the secondary single lesion measures in the interview. I look forward to seeing top line data in May.
![](http://investorshub.advfn.com/uimage/uploads/2016/3/26/cyurgpsoriasis_secondary_efficacy_endpoints.jpg)
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