One of the largest clinical studies ever led by Canadian scientists will follow 11,000 patients in 20 countries for five years

HAMILTON, ON, June 15, 2011 /CNW Telbec/ - A major international study of 11,000 elderly persons with high blood pressure (hypertension) will be led and managed by the Population Health Research Institute (PHRI) of Hamilton Health Sciences and McMaster University, thanks to a $40-million investment in Ontario by Novartis, it was announced today.

This long-term study, called APOLLO (Aliskiren Prevention of Later Life Outcomes), with a total global budget of more than $100 million, is one of the largest ever to be led by Canadian scientists. The study is being led by Dr. Salim Yusuf, Executive Director of the PHRI, Professor of Medicine at McMaster University and Vice-President of Research at Hamilton Health Sciences. APOLLO will initially follow patients in 20 countries over five years to determine the long-term benefits of aliskiren, the first of a unique new class of blood-pressure-lowering drugs known as direct renin inhibitors. Aliskiren is marketed by Novartis Pharmaceuticals Canada Inc. as Rasilez®.

APOLLO will evaluate whether lowering blood pressure with aliskiren and other drugs (diuretics and calcium channel blockers) will reduce the risk of mortality and of major cardiovascular events, such as heart attacks, strokes or heart failure in elderly patients. A novel aspect of the study is a functional ability assessment to determine if participants can continue to carry out the various complex tasks associated with independent and productive living.

The study was launched in January 2011 and is expected to be completed by mid-2017.

Novartis, the fourth-largest life sciences company in the world, has been facilitated in making this investment in Ontario by the Ontario Life Sciences Commercialization Strategy. This Ontario government program includes funding to upgrade infrastructure in the province necessary to allow such major projects to take place. The government has made an investment of $1 million in facilities at the PHRI, part of a $4-million provincial program to help promote and attract global R&D investment.

"We're supporting innovation to strengthen our healthcare system, create new jobs, and move our economy forward," said Hon. Glen Murray, Minister of Research and Innovation, who attended the study launch announcement and announced the government's investment. "The McGuinty government is ensuring that Ontario's world-class researchers have the tools they need to make new discoveries and attract new investment."

"Novartis is proud to be launching the APOLLO trial, a strategic global investment in clinical development across 20 countries, which will be led by Dr. Yusuf at the Population Health Research Institute based in Hamilton, Ontario. Of Novartis' $100-million investment, $40 million will remain in the province. This investment would not have happened without the partnership of Dr. Yusuf, an international visionary leader in cardiovascular research, and the Ontario government.  APOLLO will provide further insights on the long-term health of hypertensive patients," said Dr. Riad Sherif B, President of Novartis Pharmaceuticals Canada Inc.

"The PHRI is a world leader in conducting cutting-edge research into the prevention of heart disease and stroke," said Dr. Yusuf. "We are delighted to work on this exciting opportunity with Novartis on this major study. The findings from APOLLO have major potential to improve the health and well-being of the elderly in all parts of the world."

The partners in the PHRI see this major investment as a tribute to the strengths of their institutions and people. "Dr. Yusuf over many years has built a strong, world-class research team at PHRI, which is justly deserving of taking on this important global mandate," said Murray T. Martin, President and CEO of Hamilton Health Sciences.

Added Dr. John G. Kelton, Dean and Vice-President, Faculty of Health Sciences at McMaster University: "The APOLLO study is an important next step for Dr. Yusuf and his team who are well-known for large, international medical research studies that make a difference in people's lives."

The APOLLO study
APOLLO (Aliskiren Prevention Of Later Life Outcomes) evaluates a novel blood pressure lowering agent, aliskiren, that belongs to a unique new class of drugs called direct renin inhibitors.  Aliskiren is now approved in a large number of countries, including Canada, for the lowering of blood pressure. The APOLLO study will be conducted in 11,000 elderly individuals from over 20 countries and will investigate whether lowering blood pressure with aliskiren and with additional drugs such as diuretics or calcium channel blockers, will reduce the risk of major cardiovascular events, such as cardiovascular death, heart attacks, strokes or heart failure. A novel aspect of the study is the functional ability assessment to determine participants' ability to continue to carry out the various complex tasks associated with independent and productive living. A number of embedded studies link anatomical changes in the brain (through serial MRI measurements) with cognitive decline and ability to perform complex tasks of daily living such as banking, shopping, etc. over five years. The study will evaluate whether aliskiren modifies these changes favourably. APOLLO started in January 2011 and is expected to be completed by mid-2017. The study is led globally by the Population Health Research Institute at Hamilton Health Sciences and McMaster University in Hamilton, Canada.

Dr. Salim Yusuf
Dr. Salim Yusuf is Executive Director of the Population Health Research Institute, which he founded in 1999. He was previously the Director of the Preventive Cardiology and Therapeutics Research Program at the Hamilton Civic Hospitals Research Centre founded in 1992 from which the PHRI evolved. Dr. Yusuf is currently a Professor of Medicine at McMaster University as well as the endowed Chair for Cardiovascular Research for the Heart and Stroke Foundation of Ontario. Formerly the Director of Cardiology at Hamilton Health Sciences, Dr. Yusuf is now the Vice-President of Research. Dr. Yusuf holds a highly distinguished medical degree from St. John's Medical College and a Doctor of Philosophy from the University of Oxford which he attended as a Rhodes Scholar. Dr. Yusuf's long list of awards and accomplishments include being elected a Fellow of the Royal Society of Canada, the Prix Galien Research Award, the Louis and Artur Lucian Award for Research, the Gold Medal of the European Society of Cardiology, and the Clinical Research Prize of the American Heart Association. He has also published over 650 publications many of which are considered to be citation classics.

Novartis Pharmaceuticals Canada Inc.
Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well-being of all Canadians. In 2010, the company invested close to $100 million in research and development in Canada. Novartis Pharmaceuticals Canada Inc. employs more than 600 people in Canada. It was named for the seventh time as one of the "50 Best Employers in Canada" for 2011. For further information, please consult www.novartis.ca.

The Population Health Research Centre
The Population Health Research Institute (PHRI) was founded in 1999 as a joint Institute of Hamilton Health Sciences (HHS) and McMaster University; it is now the largest and most cited academic cardiovascular research group in Canada.  The PHRI vision is to conduct large simple studies to address questions of international importance and relevance. PHRI has conducted more than 50 global trials and epidemiological studies in more than 1500 centres in 85 countries, involving about 1 million individuals.  The PHRI research programs explore the causes and prevention of cardiovascular disease, diabetes, obesity and societal influences on health, perioperative vascular complications, and stroke. PHRI is home to about 300 researchers, physicians, scientists, epidemiologists, biostatisticians, rehabilitation experts, nutrition scientists, research coordinators, allied health professionals, and quality assurance personnel, as well as research and administrative support personnel.  PHRI also has highly-experienced operational support teams in information and communication technologies, financial and contract services, and human resources. www.phri.ca.



For further information:

Lillian Badzioch
Population Health Research Institute
905-521-2100 ext. 76090
c: 905-730-1836
        Silvie Letendre
Novartis Pharmaceuticals Canada Inc.


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