Lilly, Sankyo Announce Start of Phase 3 Clinical Trial of Antiplatelet Agent
INDIANAPOLIS, Ind., and TOKYO, Japan, Oct. 25 /PRNewswire-FirstCall/ — A Phase 3 clinical trial will begin later this year to compare the effects of prasugrel (CS-747), an investigational antiplatelet agent, with the antiplatelet market leader Plavix(R), in patients undergoing a procedure to open clogged arteries.
The study, TRITON-TIMI 38, will include 13,000 patients worldwide with acute coronary syndrome (heart attacks and/or unstable angina), who are to undergo percutaneous coronary intervention (PCI), a procedure to open a clogged heart artery. Approximately 850 hospitals in 25 countries are targeted for participation in this study.
Prasugrel is being developed by Eli Lilly and Company and Sankyo Company, Ltd. for the treatment of patients who have suffered a heart attack or heart-related chest pain.
The primary focus of the study is to compare the agents’ ability to prevent heart attack, stroke and death in patients who undergo PCI. The secondary focus will be to look at the impact on bleeding, recurrent heart- related chest pain (ischemia) or the need for additional procedures to restore blood flow (urgent target revascularization).
The study will be conducted by Lilly and Sankyo in conjunction with the TIMI Study Group, led by Eugene Braunwald, M.D., at Harvard Medical School and Brigham and Women’s Hospital in Boston, Mass. Lead investigators in the trial from TIMI will include Elliott Antman, M.D., and Stephen Wiviott, M.D. The TIMI group conducts studies on different treatment regimens for patients with heart attacks, unstable angina and other cardiovascular diseases.
“This is an exciting trial that hopefully will give us the opportunity to make an advancement in the treatment of cardiovascular disease,” said Bernhardt Zeiher, M.D., medical director of the prasugrel product team for Lilly. “Given the prevalence of heart disease around the world, the lives of many patients could be affected.”
“It is gratifying to advance products into the Phase 3 stage, especially with a strong partner like Lilly,” said Fred Senatore, M.D., Sankyo’s executive director of clinical development. “Together we hope to develop an agent that can make a difference in the lives of patients with acute coronary syndrome who are undergoing PCI.”
About Prasugrel (CS-747)
Prasugrel is an investigational oral antiplatelet agent designed to prevent platelet activation by blocking adenosine diphosphate receptors on the platelet surface. The novel oral compound was discovered by Sankyo and Ube industries, Ltd. . It is being investigated for the treatment of patients with acute coronary syndrome who undergo percutaneous coronary intervention.
About Lilly
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers — through medicines and information — for some of the world’s most urgent medical needs. Additional information about Lilly is available at http://www.lilly.com/ .
About Sankyo
Sankyo Co., Ltd. of Tokyo, one of Japan’s largest pharmaceutical companies, has a long history of discovering new classes of drugs, including the statin class of lipid-lowering drugs. Beginning with its discovery of the first statin, mevastatin, and the co-discovery of lovastatin, the first statin to be marketed, Sankyo has been a pioneer in the cardiovascular disease arena. Additionally, Sankyo discovered, developed, manufactures and markets pravastatin sodium and olmesartan medoximil, an angiotensin II receptor blocker (ARB). For further information about Sankyo and its products, log on to http://www.sankyo.co.jp/english/ .
This press release contains forward-looking statements about the potential of the investigational compound prasugrel (CS-747) and reflects Lilly’s current beliefs. However, as with any pharmaceutical product under development, there are substantial risks and uncertainties in the process of development and regulatory review. There is no guarantee that the product will receive regulatory approvals, or that the regulatory approval will be for the indication(s) anticipated by the company. There is also no guarantee that the product will prove to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly’s filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.
Plavix(R) is a registered trademark of Sanofi-Synthelabo Inc
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Eli Lilly and Company
CONTACT: Janice Chavers of Eli Lilly and Company, +1-317-651-6253(office), +1-317-332-1413 (mobile); Jo-ann Straat of Sankyo Pharma Inc. (NewJersey), +1-973-359-2602 (office); or Hiroki Hanashima of Sankyo (Tokyo),81-3-5255-7034 (office)