- Enrollment of patients in pivotal Phase 3 study to start in Q4 2015
- Second PPPSTM generated plasma-derived therapeutic to enter clinical trial stage
LAVAL, QUEBEC, CANADA – October 26, 2015 – ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF)
(“ProMetic” or the “Corporation”) announced today that the US Food and Drug Administration (“FDA”) has completed its review and has cleared the Investigational New Drug (“IND”) application for ProMetic’s IVIG for the treatment of primary immunodeficiency diseases (“PIDD”).
“We are pleased to have received regulatory clearance for our IVIG IND and now anticipate enrolment of the first patients to rapidly follow”, declared Mr. Pierre Laurin, President and Chief Executive Officer of ProMetic. “The yield advantage provided by our PPPSTM technology for more mainstream plasma-derived products such as IVIG is of great importance to our commercial strategy. The significant financial contribution from products like IVIG will greatly facilitate the pursuit of our strategy, namely the development of much needed and more affordable orphan products addressing rare diseases”, added Mr. Laurin.
The pivotal Phase III clinical trial is an open label, single arm, two-cohort multicenter study that will investigate the safety, tolerability, efficacy and pharmacokinetics of ProMetic’s plasma purified IVIG in a total of 75 patients suffering from PIDD, including 50 adults (cohort 1) and 25 children (cohort 2). The Corporation expects enrollment of patients to quickly follow as the majority of clinical sites are already prepared to proceed.
Dr John Moran, Chief Medical Officer of ProMetic, commented: “ProMetic now has a clear clinical and regulatory pathway towards the approval of its IVIG therapeutic, and we are confident that the product will meet all the requirements necessary for regulatory approval”.
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 commercial activities in the U.S., Europe, Russia, Asia and Australia.
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.