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Icagen Initiates Pediatric Clinical Development of ICA-17043 for Sickle Cell Disease

Posted on: Wednesday, 31 May 2006, 09:00 CDT

Icagen, Inc. (NASDAQ: ICGN) today announced that a safety, pharmacokinetics and pharmacodynamics study of ICA-17043 in pediatric sickle cell disease patients has been initiated. This pediatric study will be an open label, parallel group trial involving a total of 28 patients, ages six to 16, and will be conducted at up to eight academic medical centers across the U.S.

Patients will receive study medication according to one of three dosing schedules over a period of 21 days. The objective of this study is to evaluate the pharmacokinetics, pharmacodynamics and tolerability of ICA-17043 in pediatric patients with sickle cell disease. The data from this study will be used to select doses for subsequent clinical evaluations of the safety and efficacy of ICA-17043 in pediatric subjects. Pediatric patients comprise a significant portion of patients with sickle cell disease.

"We are pleased to have initiated the pediatric program," noted Greg Rigdon, Ph.D., Vice President, New Product Development, Icagen. "Sickle cell disease is a chronic, progressive illness, with manifestations of the disease appearing early in a patient's life. We look forward to fully studying the potential of ICA-17043 to improve the clinical course of patients with this disease. This initial pediatric study represents the first step in the development pathway for evaluating ICA-17043 in the pediatric population."

About ICA-17043

ICA-17043 is a novel small molecule ion channel inhibitor under development for the chronic prophylactic treatment of sickle cell disease. This novel drug candidate is taken orally and is being developed for once-a-day dosing. ICA-17043 has received both fast track designation and orphan drug designation from the U.S. Food and Drug Administration. ICA-17043 targets a particular potassium channel, called the Gardos channel, that is located on the membrane of red blood cells. In collaboration with the McNeil Pediatrics Division of McNeil-PPC, Inc., Icagen is currently conducting a pivotal Phase III clinical 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;

-- lead compounds for epilepsy and neuropathic pain, for which the Company is conducting preclinical studies;

-- a compound for atrial fibrillation, for which the Company's collaborator Bristol-Myers Squibb Company is conducting preclinical studies;

-- lead compounds for dementia, including Alzheimer's disease, for which the Company's collaborator Astellas Pharma Inc. is conducting preclinical studies, and lead compounds for attention deficit/hyperactivity disorder, which were derived from the collaboration and for which the Company is conducting preclinical studies; and

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

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, which is on file with the Securities and Exchange Commission. These risk factors include risks as to whether the Company's products 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 products, including ICA-17043, will receive approval from the U.S. Food and Drug Administration or equivalent regulatory agencies, and for which indications, and if such products receive approval, whether they will be successfully marketed; the Company's history of net losses and how long the Company will be able to operate on its existing capital resources; 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.

Source: Business Wire

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