Petites nouvelles ! 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