- IND for IVIG filed with the FDA
- License / Milestone fees secured to contribute $9 million to Q4 2014
- Enrolment of DKD patients in PBI-4050 clinical program ongoing – no serious adverse events (“SAE”) reported in the initial phase 1b/II trial
- Enrolment of patients in the Plasminogen clinical program ongoing
LAVAL, QUEBEC, CANADA, – January 6, 2015 – ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX:PFSCF)
(“ProMetic” or the “Corporation”) provided today an update on its clinical development and commercial milestones scheduled for completion in Q4 2014.
The Investigational New Drug (“IND”) application for ProMetic’s intravenous immunoglobulin (“IVIG”) was filed in December 2014 with the American Food and Drug Administration (“FDA”) and patients’ enrolment is expected to commence during this quarter.
The enrolment of patients for the Plasminogen Phase 1 clinical trial is progressing as expected. No serious adverse events were reported in the initial part of the PBI-4050 phase 1b/II trial in patients with Diabetic Kidney Disease (“DKD”).
“2014 was a year rich in product development and regulatory activities, several of which culminated in the achievement of stated milestones late in December”, stated Mr. Pierre Laurin, President and CEO of ProMetic. “This sets the stage for the clinical programs for these three drugs to advance as anticipated during 2015”, concluded Mr. Laurin.
Dr. John Moran, Chief Medical Officer of ProMetic, also commented: “The PBI-4050 Phase 1b trial is progressing as planned, and there have been no serious adverse events reported in the single dose study in these patients with moderate to severe kidney impairment. This bodes well as the clinical program for PBI-4050 is expected to expand to a multicentre study in DKD patients, as well as to include patients suffering from idiopathic pulmonary fibrosis and patients with metabolic syndrome.”
Finally, the completion of the previously announced license and strategic agreement with Generium on December 21, 2014 as well as the achievement of a development milestone in late December 2014 alone contributed approximately $ 9 Million to Q4 2014.
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.