RESEARCH TRIANGLE PARK, N.C., April 23, 2009 (GLOBE NEWSWIRE) -- Icagen, Inc. (Nasdaq:ICGN) today reported the completion of enrollment in the Company's Phase II proof-of-concept study of senicapoc in patients with allergic asthma. Initial results from this study are expected during the second half of this year.
As previously reported, the allergen challenge trial is a double-blind, placebo-controlled, parallel group study that is designed to assess the safety and efficacy of senicapoc administered orally on pulmonary function in patients with allergic asthma following exposure to a known antigen. Approximately 30 patients at two research centers in the United Kingdom were randomized in a 1:1 ratio to senicapoc or placebo. The primary efficacy analysis 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.
In addition to the allergen challenge study, Icagen is also conducting a Phase II proof-of-concept study in patients with exercise-induced asthma. This study will enroll approximately 60 patients at multiple centers throughout the United States. Enrollment is proceeding according to expectations, with approximately one-half of the study subjects enrolled to date. Initial results from this study are expected during the second half of the year.
Senicapoc is a novel orally available small molecule inhibitor of the KCa3.1 potassium ion channel. Literature data suggests a potential role for inhibitors of KCa3.1 in the treatment of a wide variety of inflammatory and immune-mediated diseases, including asthma. Results from preclinical studies demonstrated the ability of senicapoc to reverse antigen-induced increases in airway resistance and airway hyper-reactivity.
"We are very pleased to have achieved another important 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. "With its novel mechanism of action, senicapoc represents a potential new oral therapy for asthma patients, and we look forward to having the results of this trial, which we expect to be available later this year."
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. Senicapoc has previously been studied in multiple Phase I and nonclinical studies, including two year carcinogenicity studies. Two separate Phase II proof-of-concept clinical trials of senicapoc as a treatment for asthma are currently ongoing, one focused on allergic asthma and the second focused on exercise-induced asthma.
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 and 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 nine 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 a number of disease areas, including epilepsy, pain and inflammation. The Company has clinical stage programs in epilepsy and asthma.
The Icagen Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=5735
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 Annual Report on Form 10-K, filed with the SEC on March 16, 2009. 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; general economic and financial market conditions; 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.