- ProMetic’s plasminogen confirmed to be safe, well tolerated and without drug-related adverse events .
- Clinical trial to expand to Europe .
LAVAL, QUEBEC, CANADA – August 10, 2015 – ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF)
(“ProMetic” or the “Corporation”) reported today that is has successfully completed the first round of dosing of plasminogen deficient patients. ProMetic’s IV plasminogen was found to be safe, very well tolerated and there were no drug-related adverse events.
The Phase I clinical trial is an open label, single ascending dose study that is investigating the safety, tolerability and pharmacokinetics of ProMetic’s plasma purified human plasminogen in a cohort of patients suffering from plasminogen deficiency. As a result of the successful first dosing in patients, ProMetic is now proceeding with the administration of a higher dose in order to complete the pharmacokinetic profile of the drug before year-end as planned.
The clinical program will then cross-over to the phase II-III of the program where plasminogen patients will be administered multiple doses to define the optimal treatment regimen to achieve the primary end point. The FDA has agreed to an accelerated regulatory approval pathway given the rarity of the condition and the unmet medical need. To secure an accelerated pathway approval, a drug must treat a serious condition, provide a meaningful advantage over available therapies and demonstrate an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit.
“Having now confirmed the expected safety and tolerability and obtained the initial PK profiles in patients, we can now concentrate our efforts on optimizing the dosage regimen”, said Dr. John Moran, Chief Medical Officer of ProMetic. “This initial demonstration of safety and tolerability combined with the expansion of the trials in Europe will further accelerate the development program”.
This product is designed to provide replacement therapy for patients who suffer from a congenital lack of the normal plasminogen protein and/or its functional activity, and are subject to life-long medical problems, which currently have no effective treatment. Plasminogen deficiency leads to severe clinical manifestations, primarily associated with fibrous depositions on mucous membranes throughout the body. It is a multisystem disease that affects the eyes, ears, sinuses, tracheobronchial tree, genitourinary tract and gums.
ProMetic has been granted an orphan drug designation status for its human plasma derived plasminogen drug by both the FDA and the EMA for the treatment of plasminogen deficiency.
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 children with severe hypoplasminogenemia, apparently related to the deposition of fibrin in the cerebral ventricular system.
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. 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 business development activities in the U.S., Europe and Asia.
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, 2014, 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.