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Icagen Provides Update on Status of Enrollment in Pivotal Phase III Trial of ICA-17043 Print E-mail
06 Mar 2006
RESEARCH TRIANGLE PARK, N.C, USA | Mar 06, 2006 | Icagen, Inc. (NASDAQ: ICGN) today announced that the Company has recently met the midway point of enrollment in the Company's pivotal Phase III trial of ICA-17043, which is being conducted in collaboration with McNeil Consumer & Specialty Pharmaceuticals, for the chronic oral treatment of sickle cell disease, with 150 of the total expected study population of 300 patients now enrolled. The Company today also reaffirmed its prior guidance that it is targeting the second half of 2006 for the completion of enrollment.

Enrollment of half the study population in this trial is noteworthy in that the data collection for the one planned interim efficacy analysis is scheduled to be performed when at least three months of data are available for approximately half of the total study population. The interim efficacy analysis will be conducted on an unblinded basis by an independent data monitoring committee ("DMC"). Allowing time for continued treatment of those patients recently enrolled, as well as for subsequent data collection, analysis and meeting of the DMC, the Company's expectation is that the interim efficacy analysis will occur during the third quarter of 2006.

"We are very pleased to have achieved the midpoint of enrollment," said Heyward Hull, Pharm.D., Senior Vice President, Clinical Development and Regulatory Affairs of Icagen. "We look forward to continuing to enroll patients in this important Phase III, placebo-controlled trial studying the effect of ICA-17043 on the rates of vaso-occlusive crisis in subjects with sickle cell disease. In this endeavor, we greatly appreciate the efforts of the large and dedicated group of clinical investigators who are making the conduct of this study possible."

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;

-- a compound for atrial fibrillation, which is being developed by the Company's collaborator BMS and for which an initial Phase I safety study has been completed;

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

-- lead compounds for dementia, including Alzheimer's disease, for which the Company's collaborator Astellas is conducting preclinical studies, and lead compounds for attention deficit/hyperactivity disorder ("ADHD"), 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 "Certain Factors That May Affect Future Results" in the Company's most recent Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission on November 7, 2005. 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, Inc.




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