ProMetic Successfully Completes its PBI-4050 Phase I Clinical Trial
June 18 2014 - 6:00AM
Marketwired
ProMetic Successfully Completes its PBI-4050 Phase I Clinical Trial
- PBI-4050 well tolerated; no serious adverse events
reported
- PBI-4050 set to target orphan conditions in addition to
diabetic patients with chronic kidney disease
LAVAL, QUEBEC--(Marketwired - Jun 18, 2014) - ProMetic Life
Sciences Inc. (TSX:PLI) (OTCQX:PFSCF), ("ProMetic" or the
"Corporation") reported today that it has successfully completed
its PBI-4050 Phase I clinical trial in 40 healthy volunteers.
ProMetic's PBI-4050 was found to be safe and very well tolerated
without any serious adverse events reported in any of the 5 cohorts
tested.
The objectives of this oral, double blind, placebo controlled,
single ascending dose study were to demonstrate the safety and
tolerability of PBI-4050 and to establish the pharmacokinetic
profile of the drug candidate at different doses. The study design
also included a component looking at food effect on drug
absorption. The trial was conducted in 5 cohorts of 8 subjects. In
each cohort, 6 subjects received PBI-4050 and 2 subjects received
matching placebo.
"This bodes very well for the clinical program as the
therapeutic dose is expected to be at the low end of the range
tested in this clinical trial", commented Dr John Moran, Chief
Medical Officer of ProMetic, "With this excellent safety profile,
we can now test this very promising drug candidate in
patients".
Dr. Lyne Gagnon stated, "This study also confirms that PBI-4050
does not appear to have any bioavailability concerns following oral
administration. The absorption and elimination of PBI-4050 in
humans is similar to that observed in preclinical models".
"PBI-4050 is now set to move into clinical development in
diabetic patients with kidney diseases, as well as other orphan
medical conditions where diabetes and/or fibrosis is affecting key
organs such as liver, kidney, heart and lungs. We will disclose
such selected additional indications over the coming months", said
Mr. Pierre Laurin, President and Chief Executive Officer of
ProMetic.
More on PBI-4050
PBI-4050 is an orally active lead drug candidate with efficacy
and excellent safety profiles confirmed in 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 gradually 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 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 in
ProMetic's Annual Information Form for the year ended December 31,
2013, 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 and Investor relationsProMetic Life Sciences
Inc.f.dumais@prometic.com+1.450.781.0115