• PBI-4050 significantly reduces heart fibrosis in chronic kidney disease rat model
• Significant reduction of fibrosis in the kidney and liver re-confirmed
• Expands potential commercial opportunities for PBI-4050
LAVAL, QUEBEC, CANADA, – November 12, 2013 – ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF), ("ProMetic" or the "Corporation") presented new preclinical data at the 2013 American Society of Nephrology ("ASN") annual meeting held in Atlanta on November 7-10, 2013.
Cardiovascular diseases, in their broad spectrum, are collectively the major cause of death in patients
on dialysis. One of the studies performed was to determine the effect of a permanent vascular catheter on heart fibrosis and to investigate the potential protective effect of PBI-4050 on the kidneys and the heart of 5/6 nephrectomised rats. In this study, the nephrectomised rats with a catheter had 4 times more heart lesions (fibrosis, necrosis and inflammation) compared to those who did not have a catheter. The rats with catheter and treated with PBI-4050 had a significant reduction of heart lesions, fibrosis and collagen
compared to the non-treated animals. The nephrectomised rats treated with PBI-4050 also displayed a significant improvement of their renal function and a significant reduction of inflammation and fibrosis in their kidneys compared to the non-treated rats.
"This study is particularly important because it provides a potential mechanism for reducing the cardiac injury that many patients who use catheters as a vascular access while on dialysis may experience", stated Dr Raymond Hakim.
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.
"Patients with advanced CKD conditions, whether or not on dialysis, present a very complex medical
profile often involving hypertension, diabetic and cardiovascular complications. The pre-clinical data
strongly suggests that PBI-4050 could provide a novel approach to modulate the process that leads to a gradual loss of the renal function in these patients", commented Dr. Raymond Hakim.
"These new findings add significant weight to our ultimate strategic positioning of PBI-4050 going
forward", stated Dr John Moran, who added "any beneficial clinical effect in diabetic patients with chronic kidney diseases ought to be part of a new clinical mindset when evaluating the performance of a drug".
The Corporation expects to start enrolling patients in early 2014 to demonstrate efficacy.
The study results presented at the ASN conference are available on the Prometic website at: http://prometic.com/en/therapeutics/conferences.php
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, 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.
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 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.