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PBI-4050’s beneficial impact on inflammatory mediators drives Phase Ib/II clinical trial design
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PBI-4050 significantly reduces blood glucose in a type II diabetes animal model
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Significant reduction of fibrosis in the kidneys of PBI-4050 treated animals
LAVAL, Canada I April 3, 2014 I ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF), (“ProMetic” or the “Corporation”) presented new pre-clinical data at the 2014 International Society of Nephrology (“lSN”) : Nexus Symposium – New Era of Drug Discovery and Clinical Trials in Kidney Disease held in Bergamo, Italy on April 3-6, 2014.
PBI-4050 was shown to significantly reduce oxidative stress markers as well as inflammatory and profibrotic cytokines in animal models designed to emulate chronic kidney disease (CKD) and diabetic kidney disease (DKD). All of these mediators play a major role in the evolution of CKD and DKD, and some can be monitored in blood and in urine. In animal models designed to reproduce long term complications related to human Type II diabetes, PBI-4050 brought blood glucose levels back into the normal range. Ultimately the mice or rats treated with PBI-4050 displayed a significant improvement of their renal function and a significant reduction of fibrosis in their kidneys compared to the non-treated rats.
“Our Phase Ib/II clinical trial is designed to monitor the remarkable regulatory activity of PBI-4050 on biomarkers involved in the fibrosis process,” commented Dr John Moran, ProMetic’s Chief Medical Officer “while more time may be required to demonstrate reduction of fibrosis in the kidney in CKD and DKD patients, a reduction of any of these biomarkers in humans would strongly suggest that the long term beneficial effects observed in animals could also translate to patients. Moreover, the improvement in fibrosis may well be independent of the beneficial effect on blood glucose, since PBI-4050 has been shown to reduce fibrosis in multiple non-diabetic animal models.”
“These new findings underpin the strategic clinical positioning of PBI-4050 going forward”, stated Pierre Laurin President and Chief Executive Officer of ProMetic who added: “Early signs of clinical effects in diabetic patients with chronic kidney diseases may be observed in blood and urine of patients and used to set the optimal dose regimen for the long term anti-fibrotic effect in such patients”.
During the conference, Dr Lyne Gagnon and colleagues disclosed some aspects of the mechanism of action of PBI-4050. More information is available on ProMetic website: http://www.prometic.com/en/therapeutics/conferences.php
Dr. Lyne Gagnon presented an overview of all the pre-clinical data that demonstrates the ability of PBI-4050 to reduce fibrosis in the kidney and overall improve the renal function in various animal models; said models ranging from the uni-nephrectomised diabetic (db/db) mouse model simulating diabetic nephropathies (DKD) to the 5/6 nephrectomised rat model emulating chronic kidney disease (CKD) in humans.
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.
SOURCE: ProMetic Life Sciences
Post Views: 23
-
PBI-4050’s beneficial impact on inflammatory mediators drives Phase Ib/II clinical trial design
-
PBI-4050 significantly reduces blood glucose in a type II diabetes animal model
-
Significant reduction of fibrosis in the kidneys of PBI-4050 treated animals
LAVAL, Canada I April 3, 2014 I ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF), (“ProMetic” or the “Corporation”) presented new pre-clinical data at the 2014 International Society of Nephrology (“lSN”) : Nexus Symposium – New Era of Drug Discovery and Clinical Trials in Kidney Disease held in Bergamo, Italy on April 3-6, 2014.
PBI-4050 was shown to significantly reduce oxidative stress markers as well as inflammatory and profibrotic cytokines in animal models designed to emulate chronic kidney disease (CKD) and diabetic kidney disease (DKD). All of these mediators play a major role in the evolution of CKD and DKD, and some can be monitored in blood and in urine. In animal models designed to reproduce long term complications related to human Type II diabetes, PBI-4050 brought blood glucose levels back into the normal range. Ultimately the mice or rats treated with PBI-4050 displayed a significant improvement of their renal function and a significant reduction of fibrosis in their kidneys compared to the non-treated rats.
“Our Phase Ib/II clinical trial is designed to monitor the remarkable regulatory activity of PBI-4050 on biomarkers involved in the fibrosis process,” commented Dr John Moran, ProMetic’s Chief Medical Officer “while more time may be required to demonstrate reduction of fibrosis in the kidney in CKD and DKD patients, a reduction of any of these biomarkers in humans would strongly suggest that the long term beneficial effects observed in animals could also translate to patients. Moreover, the improvement in fibrosis may well be independent of the beneficial effect on blood glucose, since PBI-4050 has been shown to reduce fibrosis in multiple non-diabetic animal models.”
“These new findings underpin the strategic clinical positioning of PBI-4050 going forward”, stated Pierre Laurin President and Chief Executive Officer of ProMetic who added: “Early signs of clinical effects in diabetic patients with chronic kidney diseases may be observed in blood and urine of patients and used to set the optimal dose regimen for the long term anti-fibrotic effect in such patients”.
During the conference, Dr Lyne Gagnon and colleagues disclosed some aspects of the mechanism of action of PBI-4050. More information is available on ProMetic website: http://www.prometic.com/en/therapeutics/conferences.php
Dr. Lyne Gagnon presented an overview of all the pre-clinical data that demonstrates the ability of PBI-4050 to reduce fibrosis in the kidney and overall improve the renal function in various animal models; said models ranging from the uni-nephrectomised diabetic (db/db) mouse model simulating diabetic nephropathies (DKD) to the 5/6 nephrectomised rat model emulating chronic kidney disease (CKD) in humans.
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.
SOURCE: ProMetic Life Sciences
Post Views: 23
