Press release from Marketwire
ProMetic's Lead Drug Candidate, PBI-4050, Enters Clinical Program
- Successful completion of GLP toxicology studies enabling commencement of clinical program - Safety profile confirmed
Thursday, September 26, 2013
ProMetic's Lead Drug Candidate, PBI-4050, Enters Clinical Program06:30 EDT Thursday, September 26, 2013
LAVAL, QUEBEC--(Marketwired - Sept. 26, 2013) - ProMetic Life Sciences Inc. (TSX:PLI)(OTCQX:PFSCF), ("ProMetic" or the "Corporation") announced today that it has successfully completed the required GLP toxicology studies performed by a certified contract research organization confirming that Prometic's lead drug candidate, PBI-4050, is safe to advance into clinical trial stages.
"These positive results enable us to commence the clinical program to confirm safety in humans" stated Pierre Laurin, President and CEO of ProMetic who added "this is expected to be initially performed in healthy volunteers this year with enrollment of patients expected to begin in early 2014 to demonstrate efficacy".
Preclinical data on PBI-4050 confirms its potential as a novel therapy to inhibit inflammation and fibrosis which underlies progressive chronic renal diseases and pulmonary fibrosis as well as fibrosis in other organs such as the liver and the heart. Additional data will be presented at the forthcoming American Association for the Study of Liver Diseases (AASLD) annual meeting and at the American Society of Nephrology (ASN) annual meeting, both occurring in early November.
Dr. Lyne Gagnon, head of biology at ProMetic commented: "We are very pleased with the fact that the significant anti-fibrotic effect of PBI-4050 has been demonstrated in several different animal models. The new data to be presented at AASLD and ASN will further highlight that PBI-4050's anti-fibrotic activity is not only limited to the kidney and lungs but also extend to the liver and heart".
"ProMetic's investments in this comprehensive preclinical program yielding these positive results increase the probability that the significant therapeutic improvements observed in animals could translate into meaningful clinical benefits in humans" commented Dr John Moran, a member of ProMetic's Board of Directors. "The clinical program will be designed to leverage these findings and apply them to the appropriate patient population taking into account an optimal regulatory pathway ", added Dr Moran.
More on PBI-4050
PBI-4050 is an orally active lead drug candidates with efficacy and high safety profiles confirmed in several in vivo experiments targeting fibrosis. Fibrosis is a very complex process by which inflammation leads to the deposit of fibrous material to repair the damaged area and whereby vital organs gradually lose their functionality as normal and functional tissue is replaced by fibrotic scarring 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. (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.
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.
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