- Over 100,000 surgeries performed annually in the USA alone for persistent tympanic perforations
- New Plasminogen formulation optimized for wound healing indications
- Global patent protection for this new indication secured through Omnio partnership
LAVAL, QUEBEC, CANADA – September 6, 2016 – ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (“ProMetic” or the “Corporation”) today announced that it will be pursuing tympanic membrane perforations (“TMP”), as one of its new plasma-derived plasminogen targeted clinical indications. ProMetic expects to file its clinical trial application (“CTA”) in Q4 2016 and to initiate the clinical trial in Sweden in patients suffering from chronic tympanic membrane perforations in H1 2017.
Over 100,000 surgeries are performed annually in the USA alone to repair chronic TMP which can result from disease (particularly middle ear infection), trauma, or failure to heal after removal of tympanostomy tubes placed to ventilate the middle ear when infected. Omnio scientists in Sweden have clearly demonstrated the remarkable effect of a local plasminogen micro-injection around the perforation on the eardrum in multiple preclinical models.
“Tympanic repair represents a niche market opportunity and is just one of the new clinical indications we intend to pursue with our plasma-derived plasminogen drug candidate”, stated Mr. Pierre Laurin, ProMetic’s President and Chief Executive Officer. “The clinical efficacy demonstrated in our ongoing clinical program combined with the proof of concept data generated by Omnio on chronic wound healing and our global patent protection allows us to confidently pursue this new indication”.
Dr Sten Hellström, Senior Professor in Otorhinolaryngology at the Karolinska Institute, Stockholm, Sweden: “Based on promising preclinical investigations it is time to consider plasminogen as a more efficient treatment than the current surgical procedures. We have demonstrated in gold standard models how plasminogen treatment efficiently promotes the closure of chronic non-healing TMP. Plasminogen micro-injections provide a simple approach expected to greatly simplify treatment and so reduce morbidity and costs”.
Dr. John Moran, Chief Medical Officer of ProMetic, commented: ““It is well-established that plasminogen is critical to the normal process of healing as we also clearly demonstrated in the patients with hypoplasminogenemia who have received intravenous plasminogen during our Phase 2/3 studies. We have now successfully developed an optimal micro-injection formulation for local injection to repair chronic wounds such as persistent tympanic membrane perforations and diabetic foot ulcers. Preclinical models suggest that such injections “kick-start” a de novo healing process in chronic wounds which, for various reasons, have failed to heal. We are excited to commence the clinical development program. I am especially pleased to be working with Dr. Hellström, a world-renowned expert in this field, who will be supervising the clinical trials”.
Plasminogen is a naturally occurring protein that is synthesized by the liver and circulates in the blood. Activated plasminogen, plasmin, is a fundamental component of the fibrinolytic system and is the main enzyme involved in the lysis of blood clots and clearance of extravasated fibrin. Plasminogen is therefore vital in wound healing, cell migration, tissue remodeling, angiogenesis and embryogenesis.
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 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.