ProMetic Life Sciences Inc.
TSX : PLI
OTCQX : PFSCF

ProMetic Life Sciences Inc.

October 29, 2015 06:30 ET

ProMetic's PBI-4050 Cleared to Commence Clinical Trial in Patients With Type 2 Diabetes and Multi-Organ Fibrosis in Europe

- Clinical Trial Application clearance received from MHRA in the UK

- Enrollment of patients to commence in Q4 2015

LAVAL, QUEBEC--(Marketwired - Oct. 29, 2015) - ProMetic Life Sciences Inc. (TSX:PLI)(OTCQX:PFSCF), ("ProMetic" or the "Corporation") announced today that the clinical trial application ("CTA") for its anti-fibrotic lead drug candidate PBI-4050 in patients suffering from a condition associated with type 2 diabetes and severe multi-organ fibrosis has been cleared by the Medicines and Healthcare Products Regulatory Agency ("MHRA") in the United Kingdom.

PBI-4050 is currently in a phase II clinical trial in Canada in patients with metabolic syndrome and associated type 2 diabetes. Aside from having already demonstrated safety and tolerability of PBI-4050 in these patients, the Canadian study was also designed to detect early signs of improvement in their metabolic status and to demonstrate that the pharmacological effects observed in preclinical models translate to humans. The Corporation expects to provide preliminary results on the effect of PBI-4050 on metabolic disorders in these patients by year-end.

Dr. Lyne Gagnon, Vice-President preclinical R&D at ProMetic commented: "PBI-4050's performance was particularly remarkable in preclinical models involving both diabetic and fibrotic conditions. Patients in this group develop severe fibrosis in part because of the complications arising from these combined conditions".

"PBI-4050 has demonstrated anti-fibrotic activity in multiple organs in several different models as well as a positive effect on insulin resistance and on preservation of insulin production by the pancreas in gold standard preclinical diabetic models" said Dr. John Moran, ProMetic's Chief Medical Officer. "The trial in the UK will monitor several biomarkers of diabetes and of fibrosis and will also study the effect and function of the affected organs, including the liver, heart, and pancreas".

"These patients experience a very fast progression of fibrosis in their vital organs, which in turn affect their quality of life and life expectancy" said Mr. Pierre Laurin, President and Chief Executive Officer of ProMetic. "Demonstration of efficacy in this trial would not only provide a much needed therapeutic solution for these patients, but would also bode very well for all other fibrotic conditions".

This is an open-label, single-arm, Phase II study initially recruiting 20 patients. Each patient will be evaluated against their respective baseline which is very well documented given the severity of their medical conditions. The initial treatment period is 6 months with a possibility to extend the study. The objectives of the study are to evaluate the safety and tolerability of PBI-4050, and the effects of PBI-4050 on key organ function, disease progression and inflammatory/fibrotic markers.

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.

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 commercial activities in the U.S., Europe, Russia, Australia 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.

Contact Information

  • Pierre Laurin
    President and CEO
    ProMetic Life Sciences Inc.
    +1.450.781.0115
    p.laurin@prometic.com

    Frederic Dumais
    Senior Director, Communications and Investor relations
    ProMetic Life Sciences Inc.
    +1.450.781.0115
    f.dumais@prometic.com