RESEARCH TRIANGLE PARK, N.C., Sept. 24, 2009 (GLOBE NEWSWIRE) -- Icagen, Inc. (Nasdaq:ICGN) today announced the initiation of a proof-of-concept study of ICA-105665 in patients with photosensitive epilepsy. ICA-105665 is a novel, orally available opener of subtypes of KCNQ channels, which have been validated by both genetic and physiologic evidence as playing an important role in certain conditions characterized by abnormal neuroexcitability, such as seizures, and potentially also chronic pain disorders.
The photosensitive epilepsy study was designed with international experts including members of the Epilepsy Study Consortium and will be conducted at up to four clinical research centers in the United States with specialized expertise in the conduct of this study. Eligible subjects are those patients with demonstrated epileptiform activity by electroencephalogram (EEG) in response to photic stimulation (also called a "photoparoxysmal response to light") and represent a small subset of all patients with epilepsy. Successive cohorts consisting of four patients each will be studied at each dose level, beginning at 100mg. In accordance with a standardized protocol, patients receive single doses of placebo or ICA-105665 on successive days followed by photic stimulation with EEG monitoring. The study measures the ability of ICA-105665 to reduce the photic-induced epileptiform EEG responses, with the response observed in each cohort used to determine the subsequent dose for the next cohort. The study is expected to be completed by mid-2010.
"We are pleased to announce the initiation of the photosensitivity study," noted Seth V. Hetherington, M.D., SVP of Clinical Development and Regulatory Affairs of Icagen. "This study design has been successfully employed in the development of several antiepileptic drugs. Because of the direct correlations that can be made between plasma levels of ICA-105665 and EEG activity, we expect to collect important information regarding both the efficacy and therapeutic dose range of this novel compound. We believe that the data provided by this focused, cost-effective study will be very useful in planning for a subsequent larger Phase IIb trial in patients with chronic treatment-resistant epilepsy."
About ICA-105665
ICA-105665 is a selective opener of certain subtypes of KCNQ potassium channels. KCNQ channels have been validated by both genetic and physiologic evidence as playing an important role in certain conditions characterized by abnormal neuroexcitability, such as seizures, and potentially also chronic pain disorders. In preclinical testing, ICA-105665 has demonstrated a broad spectrum of activity in seizure models, including models of treatment-resistant seizures, as well as efficacy in certain models of pain. Both single ascending dose and multiple ascending dose Phase I studies of ICA-105665 have been completed.
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.
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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 7, 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 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.