- PBI-4050 confirmed to be safe and well tolerated in the first 12 metabolic syndrome patients
- Positive safety review by the Data Safety Monitoring Board (“DSMB”) triggers enrolment of 24 additional patients to the clinical trial
LAVAL, QUEBEC, CANADA – August 27, 2015 – ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF)
(“ProMetic” or the “Corporation”) reported today that its PBI-4050 has been confirmed to be safe and well tolerated in the first 12 metabolic syndrome with associated type 2 diabetes patients, following review of the safety data by the Data Safety Monitoring Board. ProMetic is now proceeding with the enrollment of an additional 24 patients, as planned in the study protocol design.
Dr John Moran, Chief Medical Officer of ProMetic, commented: “We are well on our way to meeting the primary endpoint of this trial, which is to confirm that PBI-4050 is safe and well tolerated by patients. The study is also investigating the effects of the drug on pro-inflammatory, pro-fibrotic and metabolic biomarkers in patients suffering from metabolic syndrome and associated type 2 diabetes”
Since the beginning of the metabolic syndrome Phase II clinical trial, the first 12 patients have received on average the equivalent of more than 2 months of dosing per patient. PBI-4050 has now therefore exceeded more than 24 months of patients/product exposure and the Corporation anticipates having partial read out on biomarkers available before the end of this year.
“The confirmation of the good safety and tolerability profiles in patients following prolonged exposure to PBI-4050 bodes very well for not only the metabolic patients but all other patients in other PBI-4050 related clinical trials as well”, mentioned Mr. Pierre Laurin, President and Chief Executive Officer of ProMetic. “The data generated so far supports the filing of additional INDs to further advance the CKD/DKD and IPF clinical trials in the US and an orphan disease clinical trial in Europe”, added Mr. Laurin.
Metabolic syndrome is a major risk factor for cardiovascular disease and for Type 2 diabetes. It consists of the constellation of central (truncal) obesity, high blood triglycerides, low HDL (“good”) cholesterol, elevated blood pressure, and elevated blood glucose.
More on Metabolic Syndrome
Metabolic syndrome is a major risk factor for cardiovascular disease and for Type 2 diabetes, and consists of the constellation of central (truncal) obesity, high blood triglycerides, low HDL (“good”) cholesterol, elevated blood pressure, and elevated blood glucose. Obesity is believed to cause a chronic inflammatory state, which leads to insulin resistance and so may in turn result in cardiovascular disease and/or Type 2 diabetes. Given the global epidemic of obesity, both in the developed and developing world, the metabolic syndrome and its consequences present a devastating public health problem. It is difficult to grasp the numbers and the overwhelming public health issues presented by the global epidemic of obesity, the metabolic syndrome, and Type 2 diabetes. The International Diabetes Federation estimates that in 2013 there were 300 million diabetics world-wide, and that that number will increase to 600 million by the year 2035. The Centers for Disease Control estimates that 34% of US adults have the metabolic syndrome, and that 1 of 3 children born in the U.S. during the year 2000 will develop diabetes during their lifetime.
More on PBI-4050
PBI-4050 is an orally active lead drug candidate with excellent safety and efficacy profiles confirmed in several in vivo experiments targeting fibrosis. Fibrosis is a very complex process by which continuing inflammation causes vital organs to lose their function as normal tissue is replaced by fibrotic scar tissue. The proof of concept data generated to date confirms our lead drug candidates’ anti-fibrotic activity in several key organs including the kidneys, the heart, the lungs and the liver. Twenty six million patients in the U.S. alone are diagnosed with chronic kidney diseases (“CKD”). Patients with severe CKD stages (3 and 4) suffer from a gradual and accelerated loss of their renal function (end-stage renal disease or ESRD) leading to the need for hemodialysis. Cardiovascular complications for ESRD patients on hemodialysis are a common cause of death.
About ProMetic Life Sciences Inc.
ProMetic Life Sciences Inc. (prometic.com) is a long established biopharmaceutical company with globally recognized expertise in bioseparations, plasma-derived therapeutics and small-molecule drug development. ProMetic offers its state of the art technologies for large-scale purification of biologics, drug development, proteomics and the elimination of pathogens to a growing base of industry leaders and uses its own affinity technology that provides for highly efficient extraction and purification of therapeutic proteins from human plasma in order to develop best-in-class therapeutics. ProMetic is also active in developing its own novel small-molecule therapeutic products targeting unmet medical needs in the field of fibrosis, anemia, neutropenia, cancer and autoimmune diseases/inflammation as well as certain nephropathies Headquartered in Laval (Canada), ProMetic has R&D facilities in the UK, the U.S. and Canada, manufacturing facilities in the UK and business development activities in the U.S., Europe and Asia.
Forward Looking Statements
This press release contains forward-looking statements about ProMetic’s objectives, strategies and businesses that involve risks and uncertainties. These statements are “forward-looking” because they are based on our current expectations about the markets we operate in and on various estimates and assumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate. Such risks and assumptions include, but are not limited to, ProMetic’s ability to develop, manufacture, and successfully commercialize value-added pharmaceutical products, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of ProMetic to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. You will find a more detailed assessment of the risks that could cause actual events or results to materially differ from our current expectations in ProMetic’s Annual Information Form for the year ended December 31, 2014, under the heading “Risk and Uncertainties related to ProMetic’s business”. As a result, we cannot guarantee that any forward-looking statement will materialize. We assume no obligation to update any forward-looking statement even if new information becomes available, as a result of future events or for any other reason, unless required by applicable securities laws and regulations. All amounts are in Canadian dollars unless indicated otherwise.