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ProMetic Reports Successful PBI-4050 Pre-IND Meeting with the FDA
|By Marketwired .
|September 3, 2014 06:30 AM EDT
LAVAL, QUEBEC -- (Marketwired) -- 09/03/14 -- ProMetic Life Sciences Inc. (TSX: PLI)(OTCQX: PFSCF), ("ProMetic" or the "Corporation") announced today it had a successful Pre-Investigational New Drug ("Pre-IND) meeting with the US Food and Drug Administration ("FDA") for its anti-fibrotic, lead drug candidate, PBI-4050.
This Pre-IND meeting with the FDA focused on ProMetic's proposed phase II clinical program, for PBI-4050, in patients with diabetic kidney disease ("DKD"), other rare diseases as well as the manufacturing and pre-clinical package that ProMetic intends to include in the IND submission.
ProMetic has already completed a Phase I clinical trial in forty (40) healthy volunteers under a Canadian Clinical Trial Application ("CTA") where PBI-4050 was found to be safe and very well tolerated without any serious adverse events reported.
Dr. John Moran, ProMetic's Chief Medical Officer, commented: "Based on this FDA meeting ProMetic now has a clear path forward regarding the design of the clinical trial to be performed in DKD patients. This is an important milestone as we move forward with this multi-center study in Canada and the USA, as we have now received valuable input and favorable comments as to how to proceed from both the FDA and Health Canada".
"As a result of these successful Pre-IND meetings with both the FDA and Health Canada, we now plan to file a series of CTAs and INDs. These will target two orphan indications in addition to DKD. We aim to initiate these trials in the fall", stated Pierre Laurin, President and Chief Executive Officer of ProMetic.
The multi-center study for DKD will be 3-arm, double-blind, placebo-controlled involving 2 different doses of PBI-4050. The trial will be performed at sites already identified across Canada and in the USA. The clinical trials targeting the orphan indications will be open label in order to monitor progress against well-established disease state baselines. The trials will monitor safety and tolerability in patients as well as the effect of PBI-4050 on recognized biomarkers for fibrosis and diabetes in blood and urine.
More on DKD
Diabetic nephropathy is a complication of long-standing diabetes mellitus, of both Type 1 and Type 2. It is increasing in incidence throughout the world, and in many countries, including the United States and Canada, is the leading cause of end-stage renal disease requiring maintenance dialysis and/or kidney transplantation.
More on PBI-4050
PBI-4050 is an orally active lead drug candidate with efficacy and excellent safety 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 gradually 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. (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 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.
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