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FDA LIFTS PARTIAL CLINICAL HOLD OF ICA-105665.


Icagen, Inc. (Nasdaq:ICGN ICGN International Corporate Governance Network ), Research Triangle Park Research Triangle Park, research, business, medical, and educational complex situated in central North Carolina. It has an area of 6,900 acres (2,795 hectares) and is 8 × 2 mi (13 × 3 km) in size. Named for the triangle formed by Duke Univ. , N.C., has reported that the FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 has lifted the partial clinical hold related to the development of ICA-105665, the company's novel orally available small molecule KCNQ KCNQ Potassium Channel, Voltage-Gated, KQT-like subfamily  potassium channel agonist, for the treatment of epilepsy. Accordingly, the company is planning to initiate a proof-of-concept study in patients with photosensitive epilepsy.

The photosensitive epilepsy study was designed with international experts including members of the Epilepsy Study Consortium and will be conducted at multiple clinical research centers in the U.S. Eligible subjects are those patients with demonstrated epileptiform activity by electroencephalogram electroencephalogram /elec·tro·en·ceph·a·lo·gram/ (EEG) (-en-sef´ah-lo-gram?) a recording of the potentials on the skull generated by currents emanating spontaneously from nerve cells in the brain, with fluctuations in potential seen as  (EEG EEG: see electroencephalography. ) in response to photic photic /pho·tic/ (fo´tik) pertaining to light.

pho·tic
adj.
1. Of or relating to light.

2. Penetrated by or receiving light.

3.
 stimulation (also called a "photoparoxysmal response to light") and represent a small subset of all patients with epilepsy. 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. The duration of an observed effect will also be measured over time. A range of doses of ICA-105665 will be studied in successive cohorts, and the response observed in each cohort will determine the subsequent dose for the next cohort. The objective of the study is to determine a potential dose range to study in subsequent, more advanced clinical trials. The study is anticipated to be completed by mid-2010 but interim results may be available earlier.

In addition, the company continues preparations for a proof-of-concept pain study, which is also expected to be initiated during the third quarter. This study will be conducted at a single clinical research site in the United Kingdom. The pain trial involves the study of healthy volunteers exposed to mildly painful stimuli under controlled conditions. The study will employ a triple cross-over design comparing the ability of ICA-105665, ibuprofen and placebo to decrease the sensation of pain in response both to the injection of a small amount of capsaicin capsaicin /cap·sa·i·cin/ (kap-sa´i-sin) an alkaloid irritating to the skin and mucous membranes, the active ingredient of capsicum; used as a topical counterirritant and analgesic.

cap·sa·i·cin
n.
 under the skin and to a simulated sunburn sunburn, inflammation of the skin caused by actinic rays from the sun or artificial sources. Moderate exposure to ultraviolet radiation is followed by a red blush, but severe exposure may result in blisters, pain, and constitutional symptoms. . Initial results from this study are expected by early 2010.

"We are pleased to be able to proceed with the development of ICA-105665 in patients with epilepsy," noted Seth V. Hetherington, M.D., SVP SVP S'il Vous Plaît (French: Please)
SVP Senior Vice President
SVP Schweizerische Volkspartei (Swiss People~s Party)
SVP Society of Vertebrate Paleontology
SVP Social Venture Partners
SVP St Vincent de Paul
 of Clinical Development and Regulatory Affairs of Icagen. "This compound is a highly selective agonist of KCNQ channel subtypes, and has demonstrated excellent activity in a broad range of preclinical epilepsy models. Additionally, in a single dose Phase I study as well as a multi-dose Phase I study comprised of both healthy volunteers and patients with epilepsy, ICA-105665 has been well tolerated at doses ranging from 30 to 400mg per day, the highest dose tested. We look forward to conducting both the photosensitive epilepsy trial and the pain trial with the goal of establishing proof-of-concept for this novel compound in epilepsy and pain."

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.

For more information, call 919/941-5206 or visit http://www.icagen.com.
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Publication:Biotech Business
Date:Sep 1, 2009
Words:562
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