Healthcare Industry News:  fast track designation 


 News Release - September 12, 2006

Icagen Reports Results of Data Monitoring Committee Meeting in Phase III Assert Trial of ICA-17043

RESEARCH TRIANGLE PARK, N.C.--(HSMN NewsFeed)--Sept. 12, 2006--Icagen, Inc. (NASDAQ:ICGN ) today announced that following a recent meeting of the independent Data Monitoring Committee ("DMC") of the Company's Phase III clinical trial for the treatment of sickle cell disease, the DMC recommended that the ASSERT trial continue its enrollment of patients on concurrent hydroxyurea therapy. This second meeting followed a review of an updated data set as requested by the DMC at a meeting earlier this year.

"We are pleased that following review of the currently available, updated data the DMC recommended continuation of the study for patients receiving concurrent hydroxyurea therapy. Few effective therapies are available for patients with sickle cell disease and none provide complete relief from complications. As in the treatment of many diseases, combination therapy may prove to be an effective approach in treating patients with sickle cell disease," said Seth Hetherington, M.D., Senior Vice President, Clinical and Regulatory Affairs of Icagen. "We plan to meet with the FDA in the near future to discuss the implications of the DMC's recommendations on our plans for clinical trials of ICA-17043. Additionally, the DMC will continue to monitor the progress of patients throughout the conduct of the ASSERT trial."

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 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 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; and
  • 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.

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: Icagen

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.

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