- Over 5 million Americans suffer from heart failure, the majority having HFrEF
- The presence of pulmonary hypertension (“PH”) with HFrEF significantly increases mortality rate
- No approved treatment exists for PH with left heart disease (“Group 2 PH”)
- New data from research conducted at the Montreal Heart Institute presented at the American Heart Association Annual Meeting in New Orleans
LAVAL, QUEBEC, CANADA, – November 14, 2016 – ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF)(“ProMetic” or the “Corporation”) today presented new results at the American Heart Association’s (AHA) Annual Meeting in New Orleans from preclinical studies performed at the Montreal Heart Institute, as well as new results on the positive effects of PBI-4050 on cardiovascular biomarkers in patients with Metabolic Syndrome and Type 2 Diabetes.
Dr. Jocelyn Dupuis, MD, PhD, Professor, Department of Medicine, Université de Montréal and a leader in PH from the Montreal Heart Institute research performed an extensive preclinical study to test the potential benefits of PBI-4050 on cardiac and lung fibrosis, respiratory function, and lung structural remodeling following a myocardial infarction (“MI”) induced by coronary artery ligation. Beginning two weeks after the MI, the animals were treated with PBI-4050 for three weeks.
Dr. Dupuis commented: “PBI-4050 effectively reduced pulmonary hypertension and right ventricular hypertrophy by reducing lung fibrosis and lung remodeling. These results strongly suggest that PBI-4050 has the potential to effectively treat the lung remodeling process in patients with Group 2 pulmonary hypertension and improve the right ventricular function. Moreover, PBI-4050 did not adversely affect the healing of the left ventricle and, in fact, we observed some improvement in left ventricular function.”
Pulmonary hypertension (PH) associated with left heart disease (known as Group 2 PH) is the most prevalent form of PH, yet there is currently no approved treatment. HFrEF, which commonly follows MI, often leads to lung remodeling characterized by myofibroblast proliferation and fibrosis, with progressive worsening of PH and with right ventricular (RV) dysfunction. The presence of PH following MI is associated with significantly worse clinical outcomes.
“The data from this study and several other experiments performed at the Montreal Heart Institute, along with the positive effects of PBI-4050 on several cardiovascular biomarkers in patients with Metabolic Syndrome, convince me that PBI-4050 may greatly benefit patients suffering from this form of pulmonary hypertension”, stated Dr. John Moran, Chief Medical Officer of ProMetic, who added: “We will be presenting more results during our forthcoming analyst day on November 21 in New York City”.
More than 5 million Americans suffer from heart failure, the majority being HFrEF. The incidence of PH in HFrEF varies from 20% to 60% according to the definition used and the sampled population. Once present, PH carries a very poor prognosis in HFrEF and there are no effective therapies. The main cause of HFrEF is coronary artery disease. The incidence increases with age and with co-morbidities such as hypertension, diabetes and renal failure, and it is common in patients with Metabolic Syndrome.
Posters presentations at the conference:
Dr Dupuis, Monday Nov 14, 2016, 2:00 PM – 3:15 PM:
PBI-4050 Therapy Selectively Improves Pulmonary Hypertension, Lung Remodeling and Right Ventricular Function in Heart Failure with Reduced Ejection Fraction
Dr Gagnon, Tuesday Nov 15, 2016, 1:30 PM – 2:45 PM
PBI-4050 Reduces Cardiovascular Biomarkers in Type II Diabetic Patients with Metabolic Syndrome
More About 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. Twenty six million patients in the U.S. alone are believed to suffer from chronic kidney diseases (“CKD”). Patients with severe CKD stages (3 and 4) suffer from a progressive loss of their renal function leading to end-stage renal disease and the need for dialysis or kidney transplant. Cardiovascular complications are the most common cause of death in dialysis patients.
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 commercial activities in the U.S., Canada, 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.