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Thursday, September 21, 2006

Failed Airports

From Biospace:

Sept. 20 /PRNewswire-FirstCall/ - NUCRYST Pharmaceuticals Corp. (NASDAQ: NCST - TSX: NCS) today announced preliminary top line results from the company's Phase 2 clinical trial examining the safety and efficacy of drug candidate, NPI 32101 in a topical cream formulation, in children and adolescents with atopic dermatitis. NPI 32101 is NUCRYST's patented active pharmaceutical ingredient.

Treatment success was defined as "total clearance" or "almost total clearance" of disease signs. An intent-to-treat analysis with 387 patients demonstrated no significant difference in disease clearance among the three treatment groups.

Analysis of the data demonstrated that 35.8% of patients receiving 2% NPI 32101 cream, 35.1% of patients receiving 1% NPI 32101 cream and 34.6% of patients receiving placebo cream achieved success in almost clearing or totally clearing their disease after 12 weeks of treatment. The success rates of both 2% and 1% NPI 32101 creams were statistically identical to that of the placebo. Although the study did not meet its primary efficacy endpoint, the higher than expected placebo response rate may have made it difficult to discern efficacy of NPI 32101. A more detailed analysis of the study is underway.

"NUCRYST is continuing to analyze data from this study so that we can evaluate options for our atopic dermatitis program with a complete understanding of the study results," said Scott H. Gillis, President & CEO, NUCRYST Pharmaceuticals. "Based on our preclinical results in a variety of in vitro and in vivo models and the consistently favorable safety data generated in all clinical studies, we believe that NPI 32101 has the potential to treat various inflammatory and infectious conditions. Therefore, we plan to continue our efforts to develop NPI 32101 for a variety of disease conditions."

This is science in the Pharmaceutical world. If at first you don't succeed try try again. Sheesh! Note the "higher than expected response rate" in the placebo group. Expectations trump actual data.

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