RESEARCH TRIANGLE PARK, N.C., Oct. 9, 2008 (GLOBE NEWSWIRE) -- Icagen, Inc. (Nasdaq:ICGN) announced today the start of a Phase II proof-of-concept clinical trial to evaluate the safety and efficacy of senicapoc, the Company's novel orally available small molecule inhibitor of the KCa3.1 potassium ion channel, in patients with allergic asthma. Results from a preclinical study demonstrated the ability of senicapoc to reverse antigen-induced increases in airway resistance and airway hyper-reactivity. The objective of the current trial is to confirm these positive results in a clinical setting.
This Phase II trial is a double-blind, placebo-controlled, parallel group study that is designed to assess the safety and efficacy of senicapoc, administered once a day for two weeks, on pulmonary function in patients with allergic asthma following exposure to a known antigen. The study will enroll approximately 30 patients randomized in a 1:1 ratio to senicapoc or placebo at sites in the United Kingdom. The primary efficacy analysis of this Phase II study is the comparison between treatment arms of the late asthmatic response caused by inhalation of allergen, measured by percent change in Forced Expiratory Volume 1 (FEV1), the amount of air that can be forcefully exhaled in one second. FEV1 is a standard, commonly used test to measure lung function.
"We are very pleased to reach this significant milestone in the development of senicapoc for asthma," stated Seth V. Hetherington, M.D., Senior Vice President of Clinical Development and Regulatory Affairs at Icagen. "Senicapoc, with its novel mechanism of action, represents a potential new oral therapy for people suffering from asthma, and we look forward to having the top-line data from the trial, which we expect to be available in 2009."
In July 2008, Icagen reported favorable results from a multiple ascending dose study of senicapoc in healthy volunteers. Data showed that senicapoc was safe and well tolerated at all doses tested and in preliminary analyses exhibited predictable and dose proportional pharmacokinetics consistent with once-daily dosing. There were no serious adverse events and no dropouts from the study. Additionally, there were no dose-limiting toxicities in any subject.
About Senicapoc
Senicapoc is a potent and selective novel small molecule inhibitor of the potassium ion channel KCa3.1. This drug candidate is taken orally and is being developed for once-a-day dosing for the treatment of asthma. In July 2008, Icagen successfully completed a Phase I multiple ascending dose clinical trial of senicapoc.
About Asthma
Asthma is a chronic inflammatory disease of the airways characterized by excessive sensitivity of the lungs, or increased reaction of the airways, to various environmental stimuli or triggers. The inflammation results in narrowed, swollen airways, increased mucus, and frequently is accompanied by constriction of the smooth muscle in the airways, or bronchoconstriction, causing difficulty breathing and the familiar wheeze often associated with the disease. While asthma cannot be cured, most people with asthma can be treated so that they have few and infrequent symptoms and can live active lives. According to the National Heart Lung and Blood Institute, about 20 million people have been diagnosed with asthma in the United States, nearly 9 million of whom are children.
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 some cases in collaboration with leading pharmaceutical companies, in a number of disease areas, including epilepsy, pain and inflammation. The Company has clinical stage programs in epilepsy and asthma.
Forward-Looking Statements
This press release contains forward-looking statements that involve a number of risks and uncertainties. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words "believes," "anticipates," "plans," "expects," "intends," and similar expressions are intended to identify forward-looking statements. Important factors that could cause actual results to differ materially from the expectations described in these forward-looking statements are set forth under the caption "Risk Factors" in the Company's most recent Quarterly Report on Form 10-Q, filed with the SEC on August 6, 2008. These risk factors include risks as to the Company's history of net losses and how long the Company will be able to operate on its existing capital resources; the Company's ability to raise additional funding; the Company's ability to maintain compliance with NASDAQ's continued listing requirements; whether the Company's product candidates will advance in the clinical trials process; the timing of such clinical trials; whether the results obtained in preliminary studies will be indicative of results obtained in clinical trials; whether the clinical trial results will warrant continued product development; whether and when, if at all, the Company's product candidates, including ICA-105665 and the Company's other lead compounds for epilepsy and neuropathic pain and senicapoc for asthma, will receive approval from the U.S. Food and Drug Administration or equivalent regulatory agencies, and for which indications, and if such product candidates receive approval, whether such products will be successfully marketed; and the Company's dependence on third parties, including manufacturers, suppliers and collaborators. We disclaim any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.