- Multiple 4 month-old open surgical wounds healed
- First signs of efficacy seen within 24 hours, healing within 2 weeks
- Patient recovering range of motion of scarred finger
- Rapid healing of chronic wounds supports ProMetic’s previously announced plasminogen wound healing program
LAVAL, QUEBEC, CANADA – May 3, 2016 – ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF)(“ProMetic” or the“Corporation”) announced today the successful treatment of another plasminogen deficient patient, in the USA, under a compassionate use IND.
Last December, the patient suffered a minor accident causing a puncture wound on his right middle finger. The wound subsequently became infected with Staphylococcus aureus and the infection spread widely within the hand. The patient required urgent surgery involving multiple surgical incisions in the fingers, palm and the back of the hand to drain the infection and preserve the function of his hand. This surgery was followed by treatment with intravenous antibiotics for 1 month followed up with oral antibiotics. As of April 12, 4 months after the initial accident, his surgical wounds had still not healed.
Other medical complications caused by the patient’s plasminogen deficiency made him unable to travel to participate in ProMetic’s ongoing Phase 2/3 plasminogen deficiency clinical trial. Therefore he was treated under an Expanded Access protocol, enabling him to receive a similar treatment regimen to that used in the Phase 2/3 trial, and plasminogen was administered by hematologists in Los Angeles, California.
“We observed a progressive and systematic healing of all the wounds on the patient’s hand over a period of 2 weeks from his first plasminogen infusion. Within 3 hours after that first infusion, we saw minor bleeding from the wounds which stopped spontaneously, – the first sign of plasminogen’s effectiveness. This was followed by the formation of scabs on the wounds which started to fall off after 12 days, just as in the normal healing process”, said Dr. John Moran, ProMetic’s Chief Medical Officer. “We are all very impressed with the speed of healing of this patient’s wounds. What is even more remarkable is that the patient has reported a significant increase in the range of motion of his middle finger, which was contracted due to the infection. In fact, from needing to write using only his thumb and index finger, he can now bend his middle finger enough to write as normal”, added Dr. Moran.
“We are very pleased that we could provide plasminogen to this patient and of the remarkable demonstration of its clinical efficacy. The speed of recovery and scope of healing observed in this plasminogen deficient patient matches those generated by our Swedish colleagues at Omnio in their hard-to-treat wounds program”, commented Mr. Pierre Laurin, President and Chief Executive Officer of ProMetic. “This latest data reconfirms our belief that the potential clinical uses of plasminogen provides multiple product opportunities for ProMetic”.
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 Plasminogen Deficiency
The most common condition associated with plasminogen deficiency is ligneous conjunctivitis, which is characterized by thick, woody (ligneous) growths on the conjunctiva of the eye, and if left untreated, can lead to blindness. The growths tend to recur after surgical excision, thereby requiring multiple surgeries.
While ligneous conjunctivitis is the best characterized lesion of plasminogen deficiency, hypoplasminogenemia is a multiorgan disease that can also affect the ears, sinuses, tracheobronchial tree, genitourinary tract, and gingiva. Tracheobronchial lesions including hyperviscous secretions can result in respiratory failure. Hydrocephalus has also been reported in children with severe hypoplasminogenemia, apparently related to the deposition of fibrin in the cerebral ventricular system.
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.