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".
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