Healthcare Industry News: cardiopulmonary
News Release - April 26, 2006
Inspire Announces Initiation of Phase 2 Clinical Trial of Platelet Aggregation InhibitorDURHAM, N.C.--(HSMN NewsFeed)--April 26, 2006--Inspire Pharmaceuticals, Inc. (NASDAQ:ISPH ) announced today the initiation of a Phase 2 clinical trial to evaluate Inspire's drug candidate, INS50589 Antiplatelet, in patients undergoing coronary artery bypass graft (CABG) surgery utilizing a cardiopulmonary bypass pump.
INS50589 is a selective and reversible inhibitor of the platelet P2Y12 adenosine diphosphate receptor. The Phase 2 clinical trial is a randomized, double-blind comparison of three doses of INS50589 (0.2, 0.5, and 1 mg/kg/hour) to placebo by intravenous infusion in approximately 160 subjects undergoing CABG surgery at approximately 20 clinical centers across the United States. There are multiple objectives of this dose-ranging trial, including measuring the reduction of postoperative bleeding and need for transfusions and monitoring the incidence of complications after surgery.
"From a clinical perspective, the ability to prevent platelet activation and aggregation in a controlled manner during cardiac surgery holds the potential to preserve platelet function, re-establish postoperative coagulation and reduce postoperative bleeding," stated Mark F. Newman, M.D., Chair, Department of Anesthesiology, Duke University Medical Center, and lead investigator of the trial. "It is exciting to study INS50589 in patients undergoing CABG surgery since the compound demonstrated in a recent Phase 1 trial the ability to modulate platelet function by binding to the P2Y12 receptor and blocking platelet aggregation."
"Our team continues to make progress in the development of INS50589, as marked by the initiation of this proof-of-concept trial," stated Christy L. Shaffer, Ph.D., President and CEO of Inspire. "We expect to have results of this trial in the first half of 2007. In addition, we recently were issued a patent for the composition and method for inhibiting platelet aggregation that covers INS50589."
INS50589 is a selective and reversible inhibitor of the platelet P2Y12 adenosine diphosphate receptor and is being developed to reduce complications in patients undergoing surgeries involving cardiopulmonary bypass. During cardiopulmonary bypass procedures, blood is diverted out of the body through a bypass pump, causing activation of platelets that results in subsequent platelet dysfunction following surgery. Platelets are components of the blood which, when activated, contribute to the formation of blood clots that help to stop bleeding. Platelet activation and post-operative platelet dysfunction may contribute to complications such as the need for blood transfusions, cognitive disorders, and pulmonary or renal dysfunction, among others. Unlike currently marketed products used for the prevention of blood clots, INS50589 has been shown in preclinical studies, including a study using a canine model of cardiopulmonary bypass surgery, and a Phase 1 clinical trial to both inhibit platelet aggregation and to be reversible. This unique profile could provide appropriate platelet aggregation inhibition and protection from activation during the bypass procedures and restoration of normal platelet function following the procedure when intravenous administration of the drug is stopped.
Inspire is a biopharmaceutical company dedicated to discovering, developing and commercializing prescription pharmaceutical products in disease areas with significant commercial potential and unmet medical needs. Inspire has significant technical and scientific expertise in the therapy areas of ophthalmology and respiratory and is a leader in the field of P2 receptors which are important drug targets in various therapeutic areas, including ophthalmology, respiratory disease and cardiovascular disease. Inspire's U.S. specialty sales force promotes Elestat® (epinastine HCl ophthalmic solution) 0.05% and Restasis® (cyclosporine ophthalmic emulsion) 0.05%, ophthalmology products developed by Inspire's partner, Allergan, Inc. Elestat and Restasis are trademarks owned by Allergan. For more information on Inspire, visit www.inspirepharm.com.
The forward-looking statements in this news release relating to management's expectations and beliefs are based on preliminary information and management assumptions. Such forward-looking statements are subject to a wide range of risks and uncertainties that could cause results to differ in material respects, including those relating to product development, revenue, expense and earnings expectations, the seasonality of Elestat, intellectual property rights, adverse litigation developments, adverse developments in the U.S. Securities and Exchange Commission (SEC) investigation, competitive products, results and timing of clinical trials, success of marketing efforts, the need for additional research and testing, delays in manufacturing, funding, and the timing and content of decisions made by regulatory authorities, including the U.S. Food and Drug Administration. Inspire cannot guarantee a positive outcome of this Phase 2 trial for INS50589 Antiplatelet, including the ability to inhibit platelet aggregation and restore normal platelet function. There can be no assurance that Inspire, either alone or with the support of any other third party, will be able to recruit sufficient patients for any clinical trial relating to INS50589. A significant amount of work will be required to advance INS50589 through clinical testing, including the completion of additional clinical trials and toxicology studies. This Phase 2 clinical trial of INS50589 may not be successful. Even if this Phase 2 clinical trial is successful, Inspire cannot, at this point, predict the timing or success of future trials, including additional Phase 2 or Phase 3 clinical trials, for INS50589. Further information regarding factors that could affect Inspire's results is included in Inspire's filings with the SEC. Inspire undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof.
Source: Inspire Pharmaceuticals
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