ProMetic's Lead Drug Candidate, PBI-4050, Enters Clinical Program
September 26 2013 - 6:30AM
OTC Markets
ProMetic's Lead Drug Candidate, PBI-4050, Enters Clinical
Program
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--(Marketwired - Sep 26, 2013) - ProMetic
Life Sciences Inc. (TSX:PLI)(OTCQX:PFSCF), ("ProMetic" or the
"Corporation") announced today that it has successfully
completed the required GLP toxicology studies performed by a
certified contract research organization confirming that Prometic's
lead drug candidate, PBI-4050, is safe to advance into clinical
trial stages.
"These positive results enable us to commence the clinical
program to confirm safety in humans" stated Pierre Laurin,
President and CEO of ProMetic who added "this is expected to be
initially performed in healthy volunteers this year with enrollment
of patients expected to begin in early 2014 to demonstrate
efficacy".
Preclinical data on PBI-4050 confirms its potential as a novel
therapy to inhibit inflammation and fibrosis which underlies
progressive chronic renal diseases and pulmonary fibrosis as well
as fibrosis in other organs such as the liver and the heart.
Additional data will be presented at the forthcoming American
Association for the Study of Liver Diseases (AASLD) annual meeting
and at the American Society of Nephrology (ASN) annual meeting,
both occurring in early November.
Dr. Lyne Gagnon, head of biology at ProMetic commented: "We are
very pleased with the fact that the significant anti-fibrotic
effect of PBI-4050 has been demonstrated in several different
animal models. The new data to be presented at AASLD and ASN will
further highlight that PBI-4050's anti-fibrotic activity is not
only limited to the kidney and lungs but also extend to the liver
and heart".
"ProMetic's investments in this comprehensive preclinical
program yielding these positive results increase the probability
that the significant therapeutic improvements observed in animals
could translate into meaningful clinical benefits in humans"
commented Dr John Moran, a member of ProMetic's Board of Directors.
"The clinical program will be designed to leverage these findings
and apply them to the appropriate patient population taking into
account an optimal regulatory pathway ", added Dr Moran.
More on PBI-4050
PBI-4050 is an orally active lead drug candidates with efficacy
and high safety profiles confirmed in several in vivo experiments
targeting fibrosis. Fibrosis is a very complex process by which
inflammation leads to the deposit of fibrous material to repair the
damaged area and whereby vital organs gradually lose their
functionality as normal and functional tissue is replaced by
fibrotic scarring 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 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.