Achieving stat sig (95%)for a P II trial is asking for a lot IMO especially since most p II trials normally have small patient samples, and patients are given a variety of doses. In this case the sample size is only 34. If you were to read a similar title for a P III trial then what you say is absolutely true.
Icagen Reports Top-line Results of Phase IIa Study of Senicapoc in Exercise-Induced Asthma
RESEARCH TRIANGLE PARK, N.C., Oct. 26, 2009 (GLOBE NEWSWIRE) -- Icagen, Inc. (Nasdaq:ICGN - News) today reported that in a proof-of-concept, Phase IIa exercise-induced asthma study, senicapoc failed to demonstrate improvement in the primary study endpoints, including maximum decrease in FEV1, time to recovery of FEV1 after exercise and area under the FEV1 curve for sixty minutes. In this double blind placebo-controlled study, 69 patients were randomized to receive either senicapoc at a maintenance dose of 40 mg/day or placebo. All subjects were tested for pulmonary function following a standardized treadmill exercise regimen at baseline, two and four weeks after treatment. The results of the pulmonary function tests were compared between the treatment groups, adjusting for differences in baseline values.
Although the Company will continue to evaluate the data from this trial, it does not anticipate continuing clinical development of senicapoc at this time. "We completed two small, cost-effective, proof-of-concept clinical studies testing the potential of senicapoc in the treatment of asthma. While we were encouraged by the results in our first study of allergic asthma, we were disappointed by the lack of effects in this second study of exercise-induced asthma," noted Seth V. Hetherington, M.D., SVP of Clinical Development and Regulatory Affairs of Icagen.
P. Kay Wagoner, President and CEO continued, "Going forward we will focus on our lead program, the novel KCNQ opener ICA-105665, which is in Phase IIa proof-of-concept trials in epilepsy and in pain, as well as on our preclinical programs, especially our collaboration with Pfizer for novel treatments for pain. Enrollment is going well in both the epilepsy and pain trials, and we are making progress in identifying clinical candidates in our Pfizer collaboration."
About Icagen
Icagen, Inc. is a biopharmaceutical company based in Research Triangle Park, North Carolina, focused on the discovery, development and commercialization of novel orally-administered small molecule drugs that modulate ion channel targets. Utilizing its proprietary know-how and integrated scientific and drug development capabilities, Icagen has identified multiple drug candidates that modulate ion channels. The Company is conducting research and development activities in a number of disease areas, including epilepsy, pain and inflammation. The Company has a clinical stage program in epilepsy and pain.
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