- PBI-4050’s unique mechanism of action shown to keep insulin-producing pancreatic beta cells alive
- PBI-4050 reduces endoplasmic reticulum (“ER”) stress and enables self-repair of the islets otherwise downregulated in diabetic patients
- PBI-4050’s effect translates into better blood glucose control in patients with type 2 diabetes and metabolic syndrome
LAVAL, QUEBEC, CANADA – June 9, 2016 – ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (“ProMetic” or the “Corporation”) reported today that Dr. Lyne Gagnon, Vice-President of Preclinical R&D at ProMetic will be giving an oral presentation at the American Diabetic Association’s upcoming annual meeting on PBI-4050’s effect on keeping insulin-producing pancreatic beta cells alive.
Dr. Gagnon will explain how PBI-4050’s unique mechanism of action enables the pancreatic cells to self-regenerate, a natural mechanism that is otherwise downregulated in diabetic patients. This presentation is scheduled to be given during the session entitled, “Keeping Beta Cells Alive” on Monday, June 13 at 15:45.
PBI-4050’s mechanism of action involves the reduction of ER stress, which is at the core of clinical complications in organs and tissues of diabetic patients, including the pancreas, the kidney and liver. ER stress is known to promote a fibrotic healing process instead of natural tissue regeneration. PBI-4050 has been shown to regulate this pathway, leading to the restoration of normal healing and restoration of function in key organs.
ProMetic previously reported a significant reduction on biomarkers related to cardiovascular and renal complications when elevated in patients with type 2 diabetes and metabolic syndrome. This reduction provides indirect evidence that the clinical benefits observed in these patients treated with PBI-4050 go beyond the control of blood glucose; they also evidence a reduction of inflammation in the heart and kidney in these patients.
- Oral presentation: PBI-4050 protects against pancreatic fibrosis by reducing macrophage and lymphocyte infiltration, increasing AMPK, reducing ER stress, and enhancing autophagy in the islets. (Session entitled: Keeping Beta Cells Alive – Monday, June 13, 3:45 pm)
In addition to Dr Gagnon’s oral presentation, Dr. Peter Senior, Professor of Medicine and Director of the Department of Endocrinology at the University of Alberta, will be presenting:
- “Safety and Effectiveness of PBI-4050 in Type 2 Diabetic Subjects with Metabolic Syndrome: Results of an Open-Label Study”. The poster will be displayed for 3 days in the poster Hall (June 11 – 13) under the category 12-E Clinical Therapeutics/New Technology–Oral Agents.
Two other posters will also be presented for 3 days at the ADA (June 11-13):
- PBI-4425, a novel anti-inflammatory/fibrotic compound, improves pancreatic and kidney function in the diabetic db/db mouse model.
- Oral treatment with PBI-4547, a novel anti-diabetic and anti-fibrotic compound, ameliorates pancreatic and kidney functions in the diabetic db/db mouse model.
Copy of all the presentations will become available on the ProMetic’s website on June 11, 2016.
More about ER stress
In cells, the endoplasmic reticulum (ER) is a multifunctional organelle essential for the synthesis, folding, and processing of secretory and transmembrane proteins. However physiological or pathological stimuli can disrupt this ER homeostasis resulting to an accumulation of misfolded and unfolded proteins, a condition known as ER stress. ER stress activates a complex signaling network referred as the Unfolded Protein response (UPR) to reduce ER stress and restore homeostasis. However, if the UPR fails to restore the ER to normality, ER stress causes cell dysfunction and death. Recent evidence further indicates that ER stress-mediated cell dysfunction and death is involved in the pathogenesis of multiple human chronic disorders, including diabetes and neurodegeneration.
More on PBI-4050
PBI-4050 is an orally active lead drug candidate with excellent safety and efficacy profiles confirmed in phase 2 clinical trials and 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 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. ProMetic is also active in developing its own novel small-molecule therapeutic products targeting unmet medical needs in the field of fibrosis, anemia, neutropenia, cancer and autoimmune diseases/inflammation as well as certain nephropathies Headquartered in Laval (Canada), ProMetic has R&D facilities in the UK, the U.S. and Canada, manufacturing facilities in the UK and commercial activities in the U.S., Canada, Europe, Russia, Asia and Australia.
Forward Looking Statements
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, 2015, 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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