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Icagen Initiates Enrollment in Pivotal Phase III Trial of ICA-17043 for the Treatment of Sickle Cell Disease

Posted on: Tuesday, 22 February 2005, 09:00 CST

RESEARCH TRIANGLE PARK, N.C., Feb. 22 /PRNewswire-FirstCall/ -- Icagen, Inc. today announced the initiation of enrollment in its pivotal Phase III trial of ICA-17043 for the treatment of sickle cell disease. The ASSERT study, or "A Stratified Sickle Event Randomized Trial," is a randomized, double-blind, placebo-controlled study in 300 patients. The study will be conducted at approximately 60 sites across the U.S. and in selected other countries.

"We are pleased to have initiated enrollment in the ASSERT study," stated P. Kay Wagoner, President and CEO of Icagen. "We look forward to working with the clinical investigators and others involved in this study to evaluate the safety and efficacy of ICA-17043 as a potential therapeutic agent for the chronic treatment of this serious disease."

Patients will be eligible for the ASSERT study if they have a diagnosis of sickle cell disease, are between the ages of 16 and 65 and have a history of at least two vaso-occlusive crises requiring a visit to a medical facility in the year prior to enrollment. The protocol provides for patients to be randomized into either a treatment arm or a placebo arm, each consisting of approximately 150 patients. Under the study protocol, patients are to be treated for a period of one year. The primary endpoint for this study is vaso- occlusive crisis rate. In addition, a number of secondary endpoints will be evaluated, including many of those, such as hemoglobin level, analyzed in the Phase II trial of ICA-17043.

About Sickle Cell Disease

Sickle cell disease is a chronic and debilitating genetic blood disorder, primarily affecting individuals of African descent, resulting in a variety of disease complications and a significantly shortened lifespan in the majority of patients. Sickle cell disease is the most common genetic disease among individuals of African descent and is prevalent worldwide. According to the American Medical Association, there are approximately 100,000 patients with sickle cell disease in the United States.

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's four most advanced programs are:

- ICA-17043 for sickle cell disease, for which the Company is conducting a

pivotal Phase III clinical trial;

- ICA-69673 for epilepsy and neuropathic pain, for which the Company is

conducting Phase I clinical trials;

- a compound for atrial fibrillation, which is being developed by the

Company's collaborator Bristol-Myers Squibb Company and is in Phase I

clinical trials; and

- a compound for dementia, including Alzheimer's disease, which is being

developed by the Company's collaborator Yamanouchi Pharmaceutical Co.,

Ltd. and is undergoing advanced preclinical testing.

Icagen is also conducting ongoing drug discovery programs focused on new therapeutics for pain disorders, inflammatory disorders and glaucoma.

Contacts:

Richard D. Katz, M.D. Thomas Smith

SVP, Finance and Corporate Development; Ogilvy PR Worldwide

Chief Financial Officer 909 Third Avenue

Icagen, Inc. New York, NY 10022

(919) 941-5206 (212) 880-5269

rkatz@icagen.com thomas.smith@ogilvypr.com

Icagen, Inc.

CONTACT: Richard D. Katz, M.D., SVP, Finance and Corporate Development,Chief Financial Officer of Icagen, Inc., +1-919-941-5206, rkatz@icagen.com;Thomas Smith of Ogilvy PR Worldwide, +1-212-880-5269,thomas.smith@ogilvypr.com, for Icagen, Inc.

Source: PRNewswire-FirstCall

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