In a recognized gold-standard preclinical model, PBI-4050 was shown to significantly:
- Protect against progression of diabetic nephropathy
- Improve survival
- Decrease fibrosis and scarring in the kidney
LAVAL, QUEBEC, CANADA, – November 13, 2014 – ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX:PFSCF)
(“ProMetic” or the “Corporation”) disclosed today during the Annual Meeting of the American Society of Nephrology (ASN) held in Philadelphia, USA, new preclinical data on PBI-4050, an orally active anti-fibrotic drug currently in clinical trial stages. Dr. Raymond Harris and Dr. Ming-Zhi Zhang from the Department of Nephrology, Vanderbilt University School of Medicine performed studies in a very severe model of accelerated type II diabetes, (eNOS -/- db/db mice). The animals in this model have concomitant type II diabetes and hypertension which mimic the conditions of several patients affected with Chronic Kidney Disease.
The authors concluded that PBI-4050 attenuates the development of diabetic nephropathies in type II diabetes through the improvement of glycemic control and the inhibition of renal TGFβ-mediated fibrotic pathways, in association with decrease in macrophage infiltration, oxidative stress and increase in autophagy. Dr. Harris and Dr. Zhang have shown in their model that PBI-4050 prevented further increase in proteinuria and decreased fibrosis, as measured by collagen deposition and confirmed by histology.
Dr Harris, Chief of Nephrology at Vanderbilt commented; “The animals treated with PBI-4050 not only showed improvement of their renal function compared to the non-treated group but also had an improved survival. This bodes well for the potential of this drug candidate in patients with DKD, who present a myriad of complications in addition to the progression of fibrosis in the kidney.”
“We are very pleased that Dr. Harris’ team confirmed our results obtained in several other animal models”, stated Dr. Lyne Gagnon, Head of Immunology & Biology Research at ProMetic who added: “Their results also validate our observation that PBI-4050 promotes a self-repair process, and helps to explain why we see a major improvement in the renal function in treated animals”.
Dr. John Moran, Chief Medical Officer, noted several important points regarding this study. First, this is a very challenging model since the mice are bred to develop severe high blood pressure in addition to their diabetes. Second, the treatment was begun late in the course of the disease, yet was able to substantially improve the outcome. Third, the treated animals had significant protection of the pancreas itself, so that serum insulin and blood glucose levels were stabilised for the duration of treatment.
The Vanderbilt University poster presented at the ASN annual meeting is available on the ProMetic corporate website: Click here
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. Twenty six million patients in the U.S. alone are diagnosed with chronic kidney diseases (“CKD”). Patients with severe CKD stages (3 and 4) suffer from a gradual and accelerated loss of their renal function (end-stage renal disease or ESRD) leading to the need for hemodialysis. Cardiovascular complications for ESRD patients on hemodialysis are a common cause of death.
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 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, 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.