image: University Hospitals Cleveland Medical Center
Credit: University Hospitals
CLEVELAND, Ohio – Promising results from a pivotal Phase 3 clinical trial of an investigational heart-attack drug were announced this week as part of the late-breaking sessions at the American Heart Association Scientific Sessions in New Orleans. The CeleBrate study of zalunfiban (DisaggproTM), from CeleCor Therapeutics, met its efficacy and safety endpoints in the treatment of STEMI (heart attack) patients. This achievement was reached, in part, with support from Harrington Discovery Institute at University Hospitals, a philanthropic organization with a mission to create new medicines for unmet need.
Zalunfiban is a next-generation investigational GPIIb/IIIa inhibitor specifically designed for use by medical first responders and emergency room personnel. It acts on the platelet GPIIb/IIIa receptor to reduce clot formation or re-open the artery. The drug is administered subcutaneously, and its antiplatelet effects wear off in about two hours, to help avoid potential interference with subsequent interventional procedures.
The vast majority of discoveries in academia fail to advance into new therapies. Barry Coller, MD, vice president for medical affairs, David Rockefeller Professor, head of the Allen and Frances Adler Laboratory of Blood and Vascular Biology, and physician-in-chief at The Rockefeller University, and co-founder of CeleCor, was the lead inventor of zalunfiban and needed support to take the investigational drug into clinical testing. Dr. Coller received Harrington’s physician-scientist award in 2015, which helped advance the goal of developing and testing zalunfiban in the pre-hospital setting.
Harrington Discovery Institute supports physician-scientists and scientists in advancing discoveries from academic labs into clinical practice by providing advanced drug and business development support, grant funding, and the opportunity to compete for acceleration funds and qualify for investment funds. Since its founding, Harrington has supported 217 drugs-in-the-making, 74 academic institutions, 43 company launches, 23 clinical candidates, and 15 licenses to pharma.
“My therapeutics development advisory team at Harrington Discovery Institute played a crucial role in where we are today,” said Dr. Coller. “They offered access to experts in multiple disciplines, which led us to reconsider the route of administration, and initiate much-needed reimbursement strategies. This positioning was instrumental in attracting new funding to advance the medication into clinical trials.”
“Harrington Discovery Institute was created to propel promising academic discoveries into medicines for patients,” said Jonathan S. Stamler, MD, President and Co-Founder, Harrington Discovery Institute, Distinguished University Professor, Robert S. and Sylvia K. Reitman Family Foundation Chair of Cardiovascular Innovation, and Professor of Medicine and of Biochemistry at University Hospitals and Case Western Reserve University. “Dr. Coller’s work is an excellent example of our mission being accomplished. We are privileged to have been able to contribute.”
CeleBrate was a pivotal Phase 3 prospective, blinded, randomized, placebo-controlled trial
designed to assess the safety and efficacy of a single subcutaneous injection of zalunfiban in STEMI (heart attack) patients in the pre-hospital setting. It enrolled 2,467 patients at 45 sites in the United States, Canada, Mexico, and Europe. Eligible STEMI patients were enrolled in the ambulance or in a hospital emergency department.
More information about the study results can be found here.
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About University Hospitals / Cleveland, Ohio
Founded in 1866, University Hospitals serves the needs of patients through an integrated network of 21 hospitals (including five joint ventures), more than 50 health centers and outpatient facilities, and over 200 physician offices in 16 counties throughout northern Ohio. The system’s flagship quaternary care, academic medical center, University Hospitals Cleveland Medical Center, is affiliated with Case Western Reserve University School of Medicine, Northeast Ohio Medical University, Oxford University, the Technion Israel Institute of Technology and National Taiwan University College of Medicine. The main campus also includes the UH Rainbow Babies & Children's Hospital, ranked among the top children’s hospitals in the nation; UH MacDonald Women's Hospital, Ohio's only hospital for women; and UH Seidman Cancer Center, part of the NCI-designated Case Comprehensive Cancer Center. UH is home to some of the most prestigious clinical and research programs in the nation, with more than 3,000 active clinical trials and research studies underway. UH Cleveland Medical Center is perennially among the highest performers in national ranking surveys, including “America’s Best Hospitals” from U.S. News & World Report. UH is also home to 19 Clinical Care Delivery and Research Institutes. UH is one of the largest employers in Northeast Ohio with more than 30,000 employees. Follow UH on LinkedIn, Facebook and Twitter. For more information, visit UHhospitals.org.
About Harrington Discovery Institute
Harrington Discovery Institute at University Hospitals in Cleveland, Ohio aims to advance academic discoveries into medicines to address unmet need. It was created in 2012 with a $50 million founding gift from the Harrington family and has supported more than 200 scientists throughout the US, UK, and Canada. Harrington Discovery Institute uses an innovation model that surrounds scientists with drug development and business expertise and employs both philanthropic funding and catalytic investment capital to advance projects into the clinic and through commercialization. For more information, visit: HarringtonDiscovery.org| LinkedIn | X