- Clinical Trial Application (“CTA”) clearance received from Health Canada
- Enrollment of first patients to begin this month
LAVAL, QUEBEC, CANADA, – November 11, 2014 – ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX:PFSCF)
(“ProMetic” or the “Corporation”) reported today that its small molecule lead compound PBI-4050 has been approved to commence clinical trials in patients suffering from Diabetic Kidney Disease (“DKD”) following the CTA clearance by Health Canada.
In the initial phase of the clinical program scheduled to commence this month, eight (8) DKD patients will be enrolled. The objectives of this double blind, placebo controlled, multi-dose study are to demonstrate the safety and tolerability of PBI-4050 and to compare the pharmacokinetic profile of the drug in DKD patients with severely impaired kidney function to that demonstrated in healthy volunteers.
“Based on our extensive preclinical studies, we do not expect to see a difference in the pharmacokinetics of PBI-4050 DKD patients when compared to healthy volunteers”, commented Dr. John Moran, Chief Medical Officer of ProMetic, “This cohort will complete our pharmacokinetic studies and will serve to define the doses we will use in the follow-on phase II studies”, added Dr. Moran.
This short study will immediately be followed by a placebo-controlled multicentre trial in DKD patients. The Corporation also expects to initiate a clinical program this quarter in patients suffering from Idiopathic Pulmonary Fibrosis.
“The acceptance of our Clinical Trial Application by Health Canada represents an important milestone in the PBI-4050 clinical development program”, said Mr. Pierre Laurin, President and Chief Executive Officer of ProMetic. “PBI-4050 shows great promise in diabetic patients with kidney diseases, as well as for orphan medical conditions where diabetes and/or fibrosis co-exists and affect key organs such as the liver, heart and lungs. We anticipate to shortly disclose one additional orphan indication targeted by PBI-4050”, added Mr. Laurin.
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 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.
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, 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.