LAVAL, QUEBEC -- (Marketwired) -- 07/11/13 -- ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF), ("ProMetic" or the "Corporation") announced today that its lead drug candidate PBI-4050, is on track to enter the clinical trial program starting in September 2013. During the first half of 2013, the Corporation has systematically executed on all key activities required to enable the initiation of the clinical trials.
The manufacturing process for its orally active anti-fibrotic lead drug candidate has been successfully scaled up in an FDA and EMA approved facility. The required GMP material has been delivered to advance the toxicology program necessary to enable the commencement of the clinical trials. Throughout the preclinical program, PBI-4050 has demonstrated efficacy with a remarkable safety profile. This is expected to be further confirmed in the on-going toxicology studies being performed by a certified contract research organisation ("CRO").
"The recently presented data on PBI-4050 confirms its potential as a novel therapy to inhibit inflammation and fibrosis which underlies most progressive chronic renal diseases" stated Dr Raymond Hakim, MD, PhD, a kidney specialist who until recently was the Chief Medical Officer of one of the largest provider of renal services in the US and a new member of ProMetic's Board of Directors. "Diabetes further accelerate the loss of kidney function in patients with CKD, and the extensive PBI-4050 preclinical data generated suggest that this patient population would greatly benefit from this therapeutic approach" added Dr Hakim.
In a well-recognized animal model designed to study the long term effect of diabetes on organs, PBI-4050 reduced kidney hyperfiltration, proteinuria, and the expression of inflammatory/fibrotic markers in kidney. These results and new data that further confirms PBI-4050's ability to reduce fibrosis in kidney were recently presented at the European Renal Association in Istanbul (http://www.prometic.com/en/therapeutics/scientific-library.php) and at the world congress in nephrology in Hong Kong (http://www.prometic.com/en/therapeutics/scientific-library.php). New results demonstrating the efficacy of PBI-4050 in a challenging pulmonary fibrosis model will be presented at the forthcoming European Respiratory Society 2013 Meeting to be held in Barcelona in September.
"Following the initial phase clinical program to confirm safety in humans to be performed in Q4 this year, we expect to start enrolling patients in early 2014 to demonstrate efficacy" commented Dr John Moran, also a member of ProMetic's Board of Directors "Patients affected by CKD cost Medicare nearly 75 billion dollars a year. Needless to say an effective therapy would greatly benefit patients and reduce the ever-growing costs to the healthcare system" added Dr Moran.
"While renal indications may represent the highest value on a long term basis, the development strategy pursued may also target other fibrotic indications as point of initial commercial entry" mentioned Pierre Laurin, CEO of ProMetic, who added "Pulmonary fibrosis for instance, is a good example of an interesting target indication for which PBI-4050 has demonstrated superior efficacy compared to the only other commercially available therapy".
More on PBI-4050
PBI-4050 is one of ProMetic 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.
The positive effects of PBI-4050 observed in several different animal models designed to reproduce chronic kidney diseases can be summarized as follows:
Increase in GFR (improvement of the renal function)
Decrease in Proteinuria (reduction of protein found in urine)
Decrease in Serum creatinine (reduction of creatinine in blood)
Decrease in Serum urea (reduction of urea in blood)
Decrease in Histological lesions (reduction of fibrosis & lesions, leading to a more functional and normal renal tissue)
Decrease of collagen deposition in the tissue
Decrease in several biomarkers confirming the reduction of inflammation and fibrosis
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.
President and CEO
ProMetic Life Sciences Inc.
Director, Communications and Investor relations
ProMetic Life Sciences Inc.
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