Positive results from Phase IIa epilepsy study of ICA-105665

Mar 16 2010

Icagen, Inc. (Nasdaq:ICGN) today reported positive results in its Phase IIa epilepsy study of ICA-105665, the Company's novel orally available small molecule KCNQ potassium channel agonist.

The photosensitive epilepsy study was a placebo-controlled, single blind study conducted at two clinical research centers in the United States with specialized expertise in the conduct of this study. The study was designed in collaboration with a group of international experts including members of the Epilepsy Study Consortium, and followed a standardized protocol that has been utilized in the development of several anti-epileptic agents. The photosensitive epilepsy model is considered by experts in the field to be useful in establishing proof-of-concept for the treatment of epilepsy.   Many currently marketed anti-epileptics have been shown to be effective in these patients.

Eligible subjects were those patients with demonstrated epileptiform activity by electroencephalogram (EEG) in response to photic stimulation and represent a small subset of the epilepsy population. All subjects continued background therapy with their concomitant anti-epileptic medications through the testing period. The study measured the ability of ICA-105665 to reduce the photic-induced epileptiform EEG response by comparing the response to a single administration of ICA-105665 with the response to placebo. All EEGs were reviewed by a centralized reader on a blinded basis.

At the top dose studied (400mg/day), two of four patients demonstrated a positive response to treatment with ICA-105665, as specified by standard pre-defined criteria. At all dose levels tested, ICA-105665 was well tolerated, with no serious adverse events, no dose limiting toxicities, and no dropouts from the study. There were also no clinically significant changes in laboratory values and no effects on any electrocardiogram parameters, including the QT interval. Adverse events related to the central nervous system were mild and consistent with those of other anti-epileptic drugs. 

"The trial met its endpoints," noted Jacqueline A. French, M.D., Professor and Director of the Clinical Trials Consortium at the NYU Comprehensive Epilepsy Center. "While more studies will be required to establish the potential utility of this compound in the treatment of epilepsy, the results of this photosensitive epilepsy model provide important proof-of-concept data for this novel drug candidate." 

In light of the results of this study as well as those of previously reported studies, the Company plans to consult with the FDA to determine next steps for the development of ICA-105665. The Company plans to report the complete results of this study at an appropriate medical conference.