ProMetic Life Sciences Inc.
TSX : PLI
OTCQX : PFSCF

ProMetic Life Sciences Inc.

May 20, 2015 07:00 ET

ProMetic Provides Update on PBI-4050 for the Treatment of Idiopathic Pulmonary Fibrosis ("IPF")

- PBI-4050 compares favorably to Nintedanib in lung fibrosis pre-clinical model

- PBI-4050 shown to reduce key pro-fibrotic markers in lung fibrosis

- PBI-4050 currently in phase II clinical trial in Canada for IPF

- IPF Orphan Drug Designation secured in the USA for PBI-4050

LAVAL, QUEBEC--(Marketwired - May 20, 2015) - ProMetic Life Sciences Inc. (TSX:PLI)(OTCQX:PFSCF), ("ProMetic" or the "Corporation") presented new pre-clinical data at the American Thoracic Society 2015 International Conference held in Denver, USA, on PBI-4050, its orally active anti-fibrotic drug candidate in phase II clinical trials for the treatment of IPF.

In the gold standard animal model used to emulate pulmonary fibrosis in humans, PBI-4050 performed favorably compared to Nintedanib, one of the two FDA-approved products for such medical use. PBI-4050 significantly reduced the amount of tissue scarring observed in the lungs of non-treated animals. In this model, the combination of PBI-4050 and Nintedanib did not provide a synergistic superior outcome, in contrast to the previously reported synergistic and positive effect on reduction of fibrotic markers seen with the combination of PBI-4050 and Pirfenidone.

"IPF is a complex medical condition involving multiple redundant pathways leading to fibrosis, making it difficult to address by relying on a traditional "single bullet" pharmacological approach", stated Mr. Pierre Laurin, President and Chief Executive Officer of ProMetic. "PBI-4050's positive effects observed on all of these known fibrotic pathways offers great promise for a significant improvement and stabilization in lung function in these patients", added Mr. Laurin.

The study results presented at the ATS annual conference demonstrated that the oral administration of PBI-4050 significantly reduced:

  • histological lesions and scars in the lungs
  • inflammatory / profibrotic cytokines (TGF-β1, CTGF, MCP-1, IL-23p19 & IL-6)
  • fibrotic markers (collagen 1, iNOS & fibronectin)
  • remodeling markers (LOX, MMP13, PAI-1, TIMP3 & ILK)
  • growth factors expression (VEGFA, EGF, PDGFα, TGF-β2, EDN1)

Dr. John Moran, Chief Medical Officer, welcomed these latest additions to ProMetic's extensive pre-clinical program. "Our in vitro studies have shown that PBI-4050 acts at multiple sites in several of the known cell pathways which lead to organ fibrosis. In pre-clinical studies, it has been effective in all animal models of fibrosis tested, and most importantly, this includes models of fibrosis affecting different organs, including the liver, kidney, heart, and lung. This greatly increases our confidence that the animal results will translate to human disease".

The posters presented at the ATS annual conference can be found on the ProMetic website at:
http://www.prometic.com/en/therapeutics/conferences.php

About Idiopathic Pulmonary Fibrosis ("IPF")

Idiopathic pulmonary fibrosis (IPF) is a chronic, devastating, and ultimately fatal disease characterized by a progressive decline in lung function. It is a specific type of interstitial lung disease in which the small air sacs of the lung, the "alveoli," gradually become replaced by fibrotic (scar) tissue and is the cause of worsening dyspnea (shortness of breath). IPF is usually associated with a poor prognosis. The term 'idiopathic' is used because the cause of pulmonary fibrosis is still unknown. IPF usually occurs in adult individuals of between 50 and 70 years of age, particularly those with a history of cigarette smoking, and affects men more often than women. IPF affects about 130,000 people in the United States, with about 48,000 new cases diagnosed annually. Approximately 40,000 people die each year with IPF, a similar number of deaths to those due to breast cancer. The 5-year mortality rate for patients with IPF is estimated to range from 50% to 70%.

More on PBI-4050

PBI-4050 is an orally active lead drug candidate with excellent safety and efficacy profiles confirmed in several in vivo experiments targeting fibrosis. Fibrosis is a very complex process by which continuing inflammation causes vital organs to lose their function as normal tissue is replaced by fibrotic scar tissue. The proof of concept data generated to date confirms our lead drug candidates' anti-fibrotic activity in several key organs including the kidneys, the heart, the lungs and the liver.

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 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.

Contact Information

  • Pierre Laurin
    President and CEO
    ProMetic Life Sciences Inc.
    p.laurin@prometic.com
    +1.450.781.0115

    Frederic Dumais
    Director, Communications and Investor relations
    ProMetic Life Sciences Inc.
    f.dumais@prometic.com
    +1.450.781.0115