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ProMetic's Lead Drug Candidate, PBI-4050, Enters Clinical Program Join our daily free Newsletter
MENAFN - - 9/26/2013 6:31:07 AM
ProMetic's Lead Drug Candidate, PBI-4050, Enters Clinical Program
- Successful completion of GLP toxicology studies enabling commencement of clinical program - Safety profile confirmed
LAVAL, QUEBEC, Sep 26, 2013 (Menafn - Marketwired via COMTEX) --ProMetic Life Sciences Inc. (otcqx FSCF), (" roMetic"or the "Corporation") announced today that it has successfullycompleted the required GLP toxicology studies performed by acertified contract research organization confirming that Prometic'slead drug candidate, PBI-4050, is safe to advance into clinical trialstages.
"These positive results enable us to commence the clinical program toconfirm safety in humans" stated Pierre Laurin, President and CEO ofProMetic who added "this is expected to be initially performed inhealthy volunteers this year with enrollment of patients expected tobegin in early 2014 to demonstrate efficacy".
Preclinical data on PBI-4050 confirms its potential as a noveltherapy to inhibit inflammation and fibrosis which underliesprogressive chronic renal diseases and pulmonary fibrosis as well asfibrosis in other organs such as the liver and the heart. Additionaldata will be presented at the forthcoming American Association forthe Study of Liver Diseases (AASLD) annual meeting and at theAmerican Society of Nephrology (ASN) annual meeting, both occurringin early November.
Dr. Lyne Gagnon, head of biology at ProMetic commented: "We are verypleased with the fact that the significant anti-fibrotic effect ofPBI-4050 has been demonstrated in several different animal models.The new data to be presented at AASLD and ASN will further highlightthat PBI-4050's anti-fibrotic activity is not only limited to thekidney and lungs but also extend to the liver and heart".
"roMetic's investments in this comprehensive preclinical programyielding these positive results increase the probability that thesignificant therapeutic improvements observed in animals couldtranslate into meaningful clinical benefits in humans" commented DrJohn Moran, a member of ProMetic's Board of Directors. "The clinicalprogram will be designed to leverage these findings and apply them tothe appropriate patient population taking into account an optimalregulatory pathway ", added Dr Moran.
More on PBI-4050
PBI-4050 is an orally active lead drug candidates with efficacy andhigh safety profiles confirmed in several in vivo experimentstargeting fibrosis. Fibrosis is a very complex process by whichinflammation leads to the deposit of fibrous material to repair thedamaged area and whereby vital organs gradually lose theirfunctionality as normal and functional tissue is replaced by fibroticscarring tissue. The proof of concept data generated to date confirmsour lead drug candidates' anti-fibrotic activity in several keyorgans including the kidneys, the heart, the lungs and the liver.Twenty six million patients in the U.S. alone are diagnosed withchronic kidney diseases ("CKD"). Patients with severe CKD stages (3and 4) suffer from a gradual and accelerated loss of their renalfunction (end stage renal disease or ESRD) leading to the need forhemodialysis. Cardiovascular complications for ESRD patients onhemodialysis are a common cause of death.
About ProMetic Life Sciences Inc.
ProMetic Life Sciences Inc. (www.prometic.com) is a long establishedbiopharmaceutical company with globally recognized expertise inbioseparations, plasma-derived therapeutics and small-molecule drugdevelopment. ProMetic offers its state of the art technologies forlarge-scale purification of biologics, drug development, proteomicsand the elimination of pathogens to a growing base of industryleaders and uses its own affinity technology that provides for highlyefficient extraction and purification of therapeutic proteins fromhuman plasma in order to develop best-in-class therapeutics andorphan drugs. ProMetic is also active in developing its own novelsmall-molecule therapeutic products targeting unmet medical needs inthe field of fibrosis, cancer and autoimmune diseases/inflammation.Headquartered in Laval (Canada), ProMetic has R&D facilities in theUK, the U.S. and Canada, manufacturing facilities in the UK andbusiness development activities in the U.S., Europe and Asia.
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发表于 2013-9-29 19:21
似乎他们可能不会在2013 AASLD.