Icagen’s Phase III Clinical Trial of ICA-17043 on Course Following Planned Safety Review
Icagen, Inc. (NASDAQ: ICGN) today announced that, following the first per protocol interim safety review, an independent data monitoring committee (“DMC”) recommended that Icagen continue its pivotal Phase III clinical trial of ICA-17043 for the treatment of sickle cell disease as planned. The DMC meets approximately every six months to review unblinded safety data from the pivotal Phase III clinical trial.
The pivotal Phase III clinical trial of ICA-17043 for the chronic treatment of sickle cell disease, called the ASSERT study, or “A Stratified Sickle Events Randomized Trial,” is a randomized, double-blind, placebo-controlled study in 300 patients. The primary endpoint for this study is vaso-occlusive crisis rate. The protocol provides for patients to be randomized into one of two arms, consisting of approximately 150 patients each: (i) an ICA-17043 treatment arm, in which patients receive an oral loading dose of 160 mg administered over a four-day period followed by a 10 mg oral daily dose; or (ii) a placebo arm. The protocol allows for the enrollment of up to 150 patients who are concurrently taking hydroxyurea and for equal distribution of patients taking hydroxyurea between the ICA-17043 and placebo arms. Patients are to be treated for a period of one year. In addition to interim safety reviews by the DMC, the study design also includes one interim efficacy analysis by the DMC. The study is being conducted at approximately 65 sites across the U.S. and in selected other countries in collaboration with McNeil Consumer & Specialty Pharmaceuticals.
“We are pleased that the DMC, after review of safety data from patients enrolled in our Phase III trial, recommended that Icagen continue with the trial as planned,” said P. Kay Wagoner, Ph.D., Chief Executive Officer of Icagen. “We are also pleased that this important program, which represents a potential breakthrough in the treatment of this very serious illness, remains very much on track.”
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 Bristol-Myers Squibb Company 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
— compounds for dementia, including Alzheimer’s disease, which are being developed by the Company’s collaborator Astellas Pharma, Inc., formerly Yamanouchi Pharmaceutical Co., Ltd., and are undergoing preclinical testing.
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.
