New company DalCor to sponsor global phase III clinical trial
DalCor Pharmaceuticals (DalCor) and the Montreal Heart Institute (MHI) announced today a collaboration in principle to conduct an international Phase III clinical trial which could result in a major clinical advance in cardiovascular personalised medicine.
The trial will seek to validate the clinical efficacy of dalcetrapib, an investigational medicine that according to a recently published analysis by the MHI could reduce cardiovascular morbidity and mortality by as much as 39% in patients with a documented recent Acute Coronary Syndrome and with the appropriate genetic profile. This Phase III clinical study will screen more than 30,000 patients across 30 countries in order to identify 5,000 patients having the appropriate genetic profile that is expected to benefit from dalcetrapib.
DalCor estimates that $250 million (USD) will be required to complete the project. MHI will be retained by DalCor as the lead academic Clinical Research Organization for the Phase III trial. The trial will be conducted in collaboration with the Montreal Health Innovations Coordinating Centre (MHICC), a division of the MHI, and other international Contract Research Organizations. Of the approximately 1,000 clinical trial sites, close to 300 will be located in the United States.
Cardiovascular disease, including coronary atherosclerosis, is the leading cause of death in the world. Recent results published this past January by MHI researchers led by Drs Jean-Claude Tardif and Marie-Pierre Dubé in Circulation: Cardiovascular Genetics indicated that patients with certain genotypes exhibited a benefit in terms of reduced cardiovascular risk when treated with dalcetrapib as compared to placebo. "Our Dal-GenE study is prospectively testing dalcetrapib in patients with a documented recent acute coronary syndrome and a specific genetic profile," said Dr. Jean-Claude Tardif, Director of the Research Center at MHI, Professor of Medicine at the University of Montreal and holder of the Canada Research Chair in personalized medicine. Typically, precision therapy results in better patient outcomes combined with potential cost reductions. "As part of this project, DalCor also funds MHI to further investigate this investigational drug's activity and increase the potential of personalised medicine options for our patients beyond the scope of this initial Phase III trial," Dr Tardif added.
The Study Executive Committee, chaired by Dr Tardif, includes the notable U.S.-based researcher Marc Pfeffer, M.D., Ph.D., Dzau Professor of Medicine at Harvard Medical School and Senior Physician in the Cardiovascular Division at the Brigham and Women's Hospital in Boston.
"If the Dal-GenE trial demonstrates that identifying and treating a specific genotype of people recovering from a heart attack can lead to an improved prognosis with use of dalcetrapib, over and above optimal therapy, then the principle of personalized medicine will be proven for the cardiovascular community," said Dr. Pfeffer.
DalCor, a company developed by San Mateo, California-based Sanderling Ventures, LLC, has licensed dalcetrapib from Roche. DalCor is a part of a Sanderling program dedicated to help bolster the biomedical industry in Quebec. This program has plans to form as many as eight companies in Quebec, representing a potential investment of more than $500 million (USD). "DalCor is the fifth new company to be formed in Quebec by Sanderling Ventures since September 2013 representing a major portion of our investment strategy for Quebec," stated Dr. Robert McNeil, Managing Director of Sanderling and DalCor's CEO. "MHI's recent new genetic discovery significantly improves the probability of a successful Phase III study. We are confident in the ability of MHI to lead this important international clinical trial."
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