ProMetic's PBI-4050 Cleared to Commence Clinical Trials in Patients with Metabolic Syndrome and Associated Type 2 Diabetes
- Clinical Trial Application ("CTA") clearance received from Health Canada - Enrollment of patients commencing in Q1 2015
LAVAL, QUEBEC--(Jan 26, 2015) - ProMetic Life Sciences Inc. (PLI.TO)(PFSCF), ("ProMetic" or the "Corporation") reported today that its orally active lead drug candidate, PBI-4050, has been approved to commence the clinical trial in patients suffering from metabolic syndrome and resulting Type 2 diabetes, following the CTA clearance by Health Canada. 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.
"One of the key objectives of this trial is to see whether the significant improvements observed in diabetic animals when treated with PBI-4050 can be translated to humans", stated Mr. Pierre Laurin, President and Chief Executive Officer of ProMetic. "Our scientists and Dr Raymond Harris' team at Vanderbilt University have clearly demonstrated that PBI-4050 has a direct effect on the pancreas itself, and by reducing inflammation and macrophage infiltration, preserves insulin production in the islets. This trial will therefore monitor several biomarkers of diabetes and of inflammation in patients, which should enable us to quickly evaluate the ability of PBI-4050 to reproduce the same benefits in humans", added Mr. Laurin.
"This is a straightforward open label design where each patient's progress will be measured against their own respective baseline," said Dr. John Moran, ProMetic's Chief Medical Officer. "For instance, PBI-4050's positive effect on insulin resistance and on preservation of insulin production by the pancreas in the preclinical models is observed within a few weeks. Our hope here, in addition to demonstrating PBI-4050's safety and tolerability in these patients, is that we can also observe similar early signs of improvement in their metabolic status. The initial phase of this clinical program calls for the enrolment of a minimum of 12 patients and maximum of 36 patients", added Dr. Moran.
ProMetic has successfully completed its PBI-4050 Phase I clinical trial in 40 healthy volunteers, in which it was found to be safe and well tolerated, with no serious adverse events. The Corporation has also started enrolling patients with diabetic kidney disease (DKD) in the multi-dose part of the Phase Ib trial and is expected to report results thereon by the end of the first quarter of 2015.
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 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. (www.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 and orphan drugs. 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.
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, 2013, 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.
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