DalCor Pharma licenses a late-stage investigational cardiovascular drug following major discovery by Montreal Heart Institute (MHI) scientists

 
New company DalCor to sponsor global phase III clinical trial to be led by MHI   

MONTREAL, DalCor Pharmaceuticals Canada Inc. (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. This program is part of a major effort by DalCor and its backers, who include significant private capital, to bolster the economy of Quebec by investing in the region's health care capabilities. 

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 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. 

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 and potential reduction in costs. "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. 

"This is a landmark study which can shift the paradigm of personalized treatment for patients with cardiovascular disease based on genomics and demonstrates the leadership of the Montreal Heart Institute in the treatment of cardiovascular disease and its position of excellence in advancing precision medicine," said Dr. Denis Roy, Chief Executive Officer of the Montreal Heart Institute. 

DalCor, a company developed by 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. "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." 

Source:  Institut de Cardiologie de Montréal