Icagen Provides Update on Status of Enrollment in Pivotal Phase III Trial of ICA-17043.RESEARCH TRIANGLE PARK Research Triangle Park, research, business, medical, and educational complex situated in central North Carolina. It has an area of 6,900 acres (2,795 hectares) and is 8 × 2 mi (13 × 3 km) in size. Named for the triangle formed by Duke Univ. , N.C. -- Icagen, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : ICGN ICGN International Corporate Governance Network ) today announced that the Company has recently met the seventy five percent point of enrollment in the Company's pivotal Phase III trial of ICA-17043 for the chronic oral treatment of sickle cell disease sickle cell disease or sickle cell anemia, inherited disorder of the blood in which the oxygen-carrying hemoglobin pigment in erythrocytes (red blood cells) is abnormal. , with 225 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 and that it expects that the interim efficacy analysis will occur during the third quarter of 2006. "We are very pleased to have achieved this seventy five percent point of enrollment," said P. Kay Wagoner, Ph.D., CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Icagen "We greatly appreciate the efforts of the dedicated group of investigators who have made the conduct of this study possible. We look forward to the completion of enrollment in this pivotal Phase III trial studying the effect of ICA-17043, a novel Gardos channel inhibitor, on the rate of vaso-occlusive crisis vaso-occlusive crisis Painful crisis Hematology A 'crisis' common in sickle cell anemia, in which 'sludged' sickled RBCs cause capillary stasis and infarction, and incapacitating musculoskeletal pain or 'referral'-type organ pain, hemoptysis, hematuria, melena, CNS in patients with sickle cell disease." About ICA-17043 ICA-17043 is a novel small molecule ion channel ion channel n. See channel. inhibitor under development for the chronic prophylactic treatment prophylactic treatment n. The institution of measures to protect a person from a disease to which he or she has been, or may be, exposed. Also called preventive 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 Red blood cells Cells that carry hemoglobin (the molecule that transports oxygen) and help remove wastes from tissues throughout the body. Mentioned in: Bone Marrow Transplantation red blood cells . In collaboration with the McNeil Pediatrics Division of McNeil-PPC, Inc., Icagen is currently conducting a pivotal Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the of ICA-17043. About Sickle Cell Disease Sickle cell disease is a chronic and debilitating de·bil·i·tat·ing adj. Causing a loss of strength or energy. Debilitating Weakening, or reducing the strength of. Mentioned in: Stress Reduction 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 American Medical Association (AMA), professional physicians' organization (founded 1847). Its goals are to protect the interests of American physicians, advance public health, and support the growth of medical science. , 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 Attention deficit/hyperactivity disorder A persistent pattern of inattention, hyperactivity and/or impulsiveness; the pattern is more frequent and severe than is typically observed in people at a similar level of development. , 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. |
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