LAVAL, QUEBEC, CANADA – February 9, 2016 – Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (“Prometic” or the “Corporation”) provided today its 2016 milestones outlook at the BIO-CEO 2016 conference.
Pierre Laurin, President and Chief Executive Officer of ProMetic announced that 2016 would be: “Another pivotal year for ProMetic with key milestone accomplishments around product development and regulatory activities aimed at driving shareholder value and long-term revenues.” He added, “As well as developing the therapeutic products already disclosed, ProMetic also intends to disclose new orphan indications, and continue to focus on business development initiatives”.
With regards to Plasminogen, the Corporation expects to:
- Further confirm the Plasminogen’s safety profile and dose regimen for congenital deficiency;
- Complete the phase II/III clinical trial for congenital deficiency;
- File a BLA (Biologic License Application) with the FDA for congenital deficiency, in H2 2016; and
- File a CTA (Clinical Trial Application) for wound healing in H2 2016.
For IVIG, ProMetic plans to complete the enrollment of all adult patients, into its clinical trial before year end.
Mr. Laurin also disclosed plans to use the Laval and Winnipeg plasma processing facilities to manufacture product to support the filing of INDs for other plasma derived products and to prepare for the commercial launch of Plasminogen.
ProMetic also expects to provide further clinical data, during 2016, from its clinical programs associated with its small-molecule lead drug candidate, PBI-4050. The anticipated disclosures include:
- additional clinical data in Q1 2016 from the ongoing type 2 diabetes clinical trial;
- preliminary data, in Q2 2016, from the ongoing Canadian open label IPF clinical trial; and
- preliminary data, in H2 2016, from the UK multi-organ fibrosis trial.
Furthermore, the Corporation expects to initiate double-blind placebo controlled clinical trials in:
- Patients with Cystic Fibrosis and related diabetes;
- Patients affected with Chronic Kidney Disease associated with diabetes (CKD)
- Patients with Idiopathic Pulmonary Fibrosis (IPF).
“We have already disclosed compelling data from our PBI-4050 open-label clinical trial in patients with Type 2 diabetes and metabolic syndrome and anticipate further clinical results, in different indications, in the coming months”, concluded Mr. Laurin.
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 commercial activities in the U.S., Canada, 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.