Press release from Marketwire
ProMetic's PBI-4050 Shown to Reduce Blood Glucose and Kidney Fibrosis in Preclinical Models of Human Type II Diabetes and Kidney Disease
- PBI-4050's beneficial impact on inflammatory mediators drives Phase Ib/II clinical trial design - PBI-4050 significantly reduces blood glucose in a type II diabetes animal model - Significant reduction of fibrosis in the kidneys of PBI-4050 treated animals
Thursday, April 03, 2014
ProMetic's PBI-4050 Shown to Reduce Blood Glucose and Kidney Fibrosis in Preclinical Models of Human Type II Diabetes and Kidney Disease09:00 EDT Thursday, April 03, 2014
LAVAL, QUEBEC--(Marketwired - April 3, 2014) - ProMetic Life Sciences Inc. (TSX:PLI) (OTCQX:PFSCF), ("ProMetic" or the "Corporation") presented new pre-clinical data at the 2014 International Society of Nephrology ("lSN") : Nexus Symposium - New Era of Drug Discovery and Clinical Trials in Kidney Disease held in Bergamo, Italy on April 3-6, 2014.
PBI-4050 was shown to significantly reduce oxidative stress markers as well as inflammatory and profibrotic cytokines in animal models designed to emulate chronic kidney disease (CKD) and diabetic kidney disease (DKD). All of these mediators play a major role in the evolution of CKD and DKD, and some can be monitored in blood and in urine. In animal models designed to reproduce long term complications related to human Type II diabetes, PBI-4050 brought blood glucose levels back into the normal range. Ultimately the mice or rats treated with PBI-4050 displayed a significant improvement of their renal function and a significant reduction of fibrosis in their kidneys compared to the non-treated rats.
"Our Phase Ib/II clinical trial is designed to monitor the remarkable regulatory activity of PBI-4050 on biomarkers involved in the fibrosis process," commented Dr John Moran, ProMetic's Chief Medical Officer "while more time may be required to demonstrate reduction of fibrosis in the kidney in CKD and DKD patients, a reduction of any of these biomarkers in humans would strongly suggest that the long term beneficial effects observed in animals could also translate to patients. Moreover, the improvement in fibrosis may well be independent of the beneficial effect on blood glucose, since PBI-4050 has been shown to reduce fibrosis in multiple non-diabetic animal models."
"These new findings underpin the strategic clinical positioning of PBI-4050 going forward", stated Pierre Laurin President and Chief Executive Officer of ProMetic who added: "Early signs of clinical effects in diabetic patients with chronic kidney diseases may be observed in blood and urine of patients and used to set the optimal dose regimen for the long term anti-fibrotic effect in such patients".
During the conference, Dr Lyne Gagnon and colleagues disclosed some aspects of the mechanism of action of PBI-4050. More information is available on ProMetic website: http://www.prometic.com/en/therapeutics/conferences.php
Dr. Lyne Gagnon presented an overview of all the pre-clinical data that demonstrates the ability of PBI-4050 to reduce fibrosis in the kidney and overall improve the renal function in various animal models; said models ranging from the uni-nephrectomised diabetic (db/db) mouse model simulating diabetic nephropathies (DKD) to the 5/6 nephrectomised rat model emulating chronic kidney disease (CKD) in humans.
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, cancer and autoimmune diseases/inflammation. 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.
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 on page 26 of ProMetic's Annual Information Form for the year ended December 31, 2012, 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.
FOR FURTHER INFORMATION PLEASE CONTACT:
President and CEO
ProMetic Life Sciences Inc.
Director, Communications and
ProMetic Life Sciences Inc.