ProMetic's PBI-4050 Shown to Reduce Blood Glucose & Kidney Fibrosis in Preclinical Models of Human Type II Diabetes & Kidney ...
April 03 2014 - 9:00AM
Marketwired
ProMetic's PBI-4050 Shown to Reduce Blood Glucose and Kidney
Fibrosis in Preclinical Models of Human Type II Diabetes and Kidney
Disease
- 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, QUEBEC--(Marketwired - Apr 3, 2014) - 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.
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 on page
26 of ProMetic's Annual Information Form for the year ended
December 31, 2012, 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.
Pierre LaurinPresident and CEOProMetic Life Sciences
Inc.p.laurin@prometic.com+1.450.781.0115Frederic DumaisDirector,
Communications andInvestor RelationsProMetic Life Sciences
Inc.f.dumais@prometic.com+1.450.781.0115