Update on ICA-105665 clinical development plans for treatment of epilepsy and pain

Icagen, Inc. (Nasdaq:ICGN) today provided an update on clinical development plans for ICA-105665, the Company's novel drug candidate for the treatment of epilepsy and pain.

As previously reported, ICA-105665 demonstrated positive results in a recent Phase IIa study in patients with photosensitive epilepsy. At the top dose studied (400 mg as a single dose), two of four patients demonstrated a positive response to treatment, as specified by standard pre-defined criteria. In all studies to date, the pharmacokinetics of ICA-105665 suggest twice per day dosing without the need for titration to reach doses which can be tolerated. Based upon the efficacy demonstrated in the recent study of photosensitive epilepsy patients, coupled with a favorable clinical safety profile, consistent pharmacokinetics and the lack of a maximal tolerated dose in all clinical studies to date, the Company proposed, and the FDA approved, a study of up to two additional cohorts of photosensitive epilepsy patients at higher doses of ICA-105665. In addition, subject to review of a finalized protocol, the FDA agreed to a second study of higher doses of ICA-105665 in a multiple ascending dose trial of healthy volunteers. The objective of both of these studies is to evaluate higher doses of ICA-105665 in order to optimize dose selection for subsequent larger clinical trials. 

The Company currently expects that these clinical studies at higher doses may be completed during the second half of 2010, subject to available funding. If the completion of the currently planned studies is successful, the Company plans to initiate a Phase IIb study in patients with treatment-resistant, partial-onset epilepsy.  As currently planned, the Phase IIb trial is expected to be a double blind, placebo controlled study in patients who have seizures despite treatment with optimal medical therapy. The primary endpoint is expected to be a reduction in seizure frequency. The Phase IIb will be designed with input from the FDA, but will likely enroll 60 to 120 patients and be similar to other studies that have been utilized at this stage of the development of other anti-epileptics.

"We are pleased that the FDA has supported our plans to study higher doses of ICA-105665. While we are encouraged with the efficacy we have seen to date, given that ICA-105665 has been well-tolerated by both healthy volunteers and patients up to the highest dose tested without dose-limiting side effects, we believe that it is prudent to investigate higher doses. These data will provide a stronger rationale for dose selection in future trials, both for epilepsy and for other indications such as pain," noted P. Kay Wagoner, Icagen's President and CEO.