- Enrollment of Phase I patients to start in Q4 2014.
- Agreement for the proposed Phase II/III clinical program to follow an accelerated approval pathway.
- First PPPSTM generated plasma-derived therapeutic to enter clinical trial stages .
ROCKVILLE, MARYLAND, USA: LAVAL, QUEBEC, CANADA – October 28, 2014 – ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF)
(“ProMetic” or the”Corporation”) announced today that the US Food and Drug Administration (“FDA”) has completed its review and has cleared the Investigational New Drug (“IND”) application for ProMetic’s IV plasminogen for the treatment of hypoplasminogenemia, or type I plasminogen deficiency. When approved, this product will provide replacement therapy for patients with this condition, 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.
The FDA has also accepted that ProMetic’s proposed Phase II / III clinical program for the IV Plasminogen provides an adequate surrogate endpoint for licensure using the accelerated approval pathway. 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.
“We are very pleased with the FDA’s decision and welcome their support to bring an innovative and tangible medical solution for patients affected by this severe condition that has no adequate treatment”, declared Mr. Pierre Laurin, President and Chief Executive Officer of ProMetic. “Seeing our first PPPSTM plasma-derived therapeutic enter the clinical trial stages also represents an important milestone achievement for ProMetic as we get ready to proceed with additional plasma-derived products targeting other orphan indications”, added Mr. Laurin.
The Phase I clinical trial is an open label, single ascending dose study that will investigate the safety, tolerability and pharmacokinetics of ProMetic’s plasma purified human plasminogen in 6 patients suffering from hypoplasminogenemia. The Corporation expects enrollment to commence this quarter and to progress to Phase II / III in H1 2015, and to enroll a total of 15 to 18 patients. Under the current program the Corporation expects to be in a position to be ready to file a Biological License Application (BLA) for plasminogen commercialization in Q4 2015.
Dr John Moran, Chief medical Officer of Prometic commented: “This is a significant gain for the patients and their families as it will make available for the first time an effective replacement therapy. We are committed to aggressively progressing our clinical program for the benefit of all stakeholders.”
Hypoplasminogenemia is a rare autosomal recessive disorder that 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. There is no effective replacement therapy currently available for this disease.
Plasminogen Conference Call
ProMetic will be holding a plasminogen update conference call and webcast on Wednesday October 29, 2014 at 11:00am (ET). ProMetic will also review its ongoing clinical programs and will provide a corporate update during the conference call / webcast.
The telephone numbers to access the conference call are 647-788-4922 (International) and 1-877-223-4471 (North America Toll-Free). A live audio webcast of the conference call will be available via: http://www.gowebcasting.com/6110
An audio replay of the call will be available as of Wednesday October 29, 2014, at 2:00pm (E T). The numbers to access the audio replay are (416) 621-4642 (international) and 1 (800) 585-8367 (North America Toll Free) using access code: 27393265.
About the Accelerated Approval Pathway:
To find out more about the accelerated approval pathway, please refer to the Guidance for Industry, Expedited Programs for Serious Conditions – Drugs and Biologics for more details at: FDA.gov
Plasminogen is a naturally occurring protein that is synthesized by the liver and circulates in the blood. Activated plasminogen, plasmin, is an enzymatic 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 involved in wound healing, cell migration, tissue remodeling, angiogenesis and embryogenesis.
About Hypoplasminogenemia or Type 1 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 actually a multisystem 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, 2013, 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.