Positive response in kidney and urinary tract to ProMetic's plasminogen treatment in a plasminogen deficient patient under an expanded access (compassionate use) protocol in the USA

  • Left kidney blocked by fibrous material despite 7 surgeries
  • Patient chose plasminogen treatment in lieu of 8th kidney surgery
  • Significant amount of fibrous material eliminated in urine within a few days of plasminogen infusion
  • Follows previously announced rapid healing of multiple 4 month old surgical wounds in the hand of same patient

LAVAL, QC, May 11, 2016 /CNW/ - ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) ("ProMetic" or the "Corporation") announced today that the plasminogen deficient patient treated under a compassionate use IND in the USA has shown an additional significant positive response to the treatment; in this case, in his kidney and urinary tract. The Corporation has previously reported the rapid healing of this patient's multiple 4 month old surgical wounds on his hand.

This patient also has a long history of kidney stones and fibrous material formation in his left kidney and ureter related to his plasminogen deficiency.  The excess fibrous material causes obstructions and also provides a nucleus for stone formation. Seven or more previous surgeries to relieve obstructions over the years were always followed by relapses in the absence of normal plasminogen blood levels.  Therefore, the patient decided to defer any further surgery without first receiving plasminogen replacement therapy.

In addition, this patient was in continuous pain, and was 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, thus enabling him to receive a treatment regimen similar to that used in the Phase 2/3 plasminogen congenital deficiency trial, and plasminogen was administered by hematologists in Los Angeles, California.

Dr. John Moran, ProMetic's Chief Medical Officer commented, "We are very pleased to see this first evidence of response in the kidney and urinary tract. Within a few days of receiving plasminogen infusion, fibrous material blocking the kidney was breaking down and appeared in the urine. He has passed collections of very small stones ("gravel") as well as three larger stones. With repeated infusions the anticipation is that the kidney and the urinary tract will heal itself with plasminogen replacement therapy", concluded Dr. Moran.

"We are very proud to be able to provide relief to this patient who has already undergone so many surgeries for this painful condition", stated Mr. Pierre Laurin, Chief Executive Officer of ProMetic. "We know there are many other patients out there who will eventually be able to benefit from our Plasminogen replacement therapy and avoid the need for recurring surgeries", added Mr. Laurin.

About Plasminogen

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.

About ProMetic      

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.

For further information: Pierre Laurin, President and CEO, ProMetic Life Sciences Inc, p.laurin@prometic.com, 450.781.0115; Frederic Dumais, Senior Director, Communications & Investor Relations, ProMetic Life Sciences Inc., f.dumais@prometic.com, 450-781-0115

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