Biotech Values

[mcbio]

ICGN reports "positive" Phase 2 data for senicapoc

[Can one consider a study as truly positive when none of the primary or secondary endpoints reached statistical significance?]

http://finance.yahoo.com/news/Icagen-Reports-Top-Line-pz-2551067157.html?x=0&.v=1

Icagen Reports Top Line Results of Phase IIa Study of Senicapoc in Allergic Asthma

RESEARCH TRIANGLE PARK, N.C., Sept. 1, 2009 (GLOBE NEWSWIRE) -- Icagen, Inc. (Nasdaq:ICGN - News) reported today top line results of a randomized, double-blind, placebo-controlled, proof-of-mechanism Phase IIa study of senicapoc in allergic asthma. Senicapoc reduced the late asthmatic response (LAR) to a challenge of inhaled allergen, the primary endpoint of the study, as determined by the decline in FEV1, the volume of air that can be forcibly exhaled in one second. The improvement in the average decline in FEV1 was 29% (p=0.06), in the maximum decline 18% (p=0.15), and in the area under the curve 28% (p=0.08) of FEV1. Compared to their respective baselines, patients receiving senicapoc demonstrated an improvement in all measures of the LAR, while those receiving only placebo treatments had no improvements in any measure of the LAR. The magnitude of the observed responses matched that anticipated in the study design, but the greater than expected inter and intra-patient variability resulted in a reduction of the power of the study.

A total of 34 patients with demonstrated asthmatic responses to inhaled allergen were enrolled at two clinical research centers in the United Kingdom. Patients were randomized equally to receive either senicapoc or placebo administered orally once daily following an initial loading dose for a treatment period of approximately two weeks. An allergen challenge was conducted at screening to evaluate the baseline LAR, and again at the completion of the treatment period to determine changes in LAR by measuring changes in FEV1. Thirty one patients were evaluable for the study endpoints.

A secondary endpoint, the fraction of exhaled nitric oxide, a measure of airway inflammation that is typically elevated in asthmatic patients, was reduced by 24% (p=0.10) among patients who received senicapoc, compared to patients who received placebo. An additional secondary endpoint, the early asthmatic response was unchanged, as expected from preclinical studies. Consistent with other studies conducted to date, senicapoc was found to be well tolerated, and there were no serious adverse events in the study. Additional analysis and review of the data are ongoing. The Company plans to present the complete results of the study at an upcoming scientific conference.

As previously reported, the Company has completed enrollment in a randomized, double-blind, placebo-controlled trial of senicapoc in patients with exercise-induced asthma. A total of 69 patients were enrolled at several clinical research centers across the U.S. The primary endpoint is a comparison across treatment arms of the change in FEV1 after exercise. Secondary endpoints include changes in pre-exercise pulmonary function and asthma control as assessed by a questionnaire. Results from this second proof of concept study are expected during the fourth quarter of this year.

"We are pleased with the results of this study, and believe that they justify further evaluation of senicapoc as a novel approach to the treatment of asthma," said Seth Hetherington, M.D., Senior Vice President of Clinical and Regulatory Affairs. "We believe that the combination of the reduction in LAR among the senicapoc-treated patients, along with the improvement in the fraction of exhaled nitric oxide, is consistent with the potential for an anti-inflammatory effect of senicapoc, a selective blocker of the KCa3.1 channel."

About Senicapoc

Senicapoc is a novel, orally administered compound that selectively blocks the KCa3.1 channel, which is present in cells important to the inflammatory process of asthma including mast cells, neutrophils, lymphocytes, epithelial cells and airway smooth muscle cells. Blocking the KCa3.1 channel limits the influx of calcium into these cells. Such calcium influx is a trigger for inflammation, including the release of cytokines (chemicals that mediate inflammation) from immune system cells. Senicapoc has been tested in multiple Phase I studies and has been well tolerated at all doses studied.

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 clinical stage programs in epilepsy and asthma.