ProMetic Completes Adult Patients' Enrolment in Pivotal IVIG Phase 3 Clinical Trial
- Milestone achieved five months ahead of schedule
- ProMetic well positioned to become first Canadian provider of locally manufactured IVIG to serve rapidly growing Canadian market
LAVAL, QC, Aug. 9, 2016 /CNW Telbec/ - ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) ("ProMetic" or the "Corporation") announced today that it has completed the enrolment of the adult patient population (50 adult patients) in its pivotal IVIG phase III clinical trial for the treatment of primary immunodeficiency diseases ("PIDD").
The ongoing pivotal Phase III clinical trial is an open label, single arm, two-cohort multicenter study investigating the safety, tolerability, efficacy and pharmacokinetics of ProMetic's plasma derived IVIG in a total of 75 patients suffering from PIDD, including 50 adults (cohort 1) and 25 children (cohort 2). ProMetic anticipates the completion of enrollment of cohort 2 to rapidly follow having now completed the enrolment of adult patients.
"Canadian patients are amongst the largest consumers of IVIG on a per capita basis worldwide and the demand continues to grow at a rapid pace. As a Canadian based company, we intend to play an important role in facilitating the pursuit of national self-sufficiency by being the first Canadian based provider to locally manufacture and provide access to mainstream plasma derived therapeutics such as IVIG and orphan drug candidates such as plasminogen", declared Mr. Pierre Laurin, President and Chief Executive Officer of ProMetic. "Self-sufficiency for the production and distribution of key plasma derived therapeutics represent a growing concern in a number of both established and emerging markets around the world. The manufacturing advantages provided by our proprietary PPPSTM technology can help alleviate dependence on foreign plasma derived therapeutics and align local production with local demand", added Mr. Laurin.
According to Mr. Bill Bees, Vice-President, Plasma Technology at ProMetic Plasma Resources, "We intend to leverage our Winnipeg plasma center expertise for the collection of Source Plasma by expanding our capacity in North America so that supply of IVIG for Canadians can be ensured in the future".
ProMetic anticipates completing the IVIG pivotal phase 3 clinical trial in H2 2017 and rapidly submit thereafter a Biologics License Application ("BLA"), making IVIG the second plasma derived therapeutic targeted for commercialization after its orphan disease plasminogen drug candidate currently in final clinical trial stages for the treatment of plasminogen congenital deficiency.
According to recent market data, Canada is ranked as the second country in the world after the United States for the average consumption of IVIG (kilograms per million people). The global IVIG market CAGR is expected to reach 5-6% between 2016 and 2025 with Canada having one of the lowest IVIG self-sufficiency ratios (less than 25%).
Intravenous immunoglobulin is a preparation of antibodies purified from plasma donations from normal individuals. It is indicated for the maintenance treatment of patients with primary immunodeficiencies (PID) including common variable immunodeficiency, X-linked agammaglobulinemia, severe combined immunodeficiency. It is also indicated for the treatment of immune thrombocytopenic purpura (ITP). It is also used for the treatment of many other autoimmune diseases, including Guillain-Barré syndrome, Kawasaki disease
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. 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, 2015, 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.
SOURCE ProMetic Life Sciences Inc.