LAVAL, QUEBEC–(Marketwired – July 11, 2013) – 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.
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