WOODBRIDGE, ON, April 7, 2015 /PRNewswire/ - Pivotal
Therapeutics Inc. (OTCQX:PVTTF; CSE:PVO), ("Pivotal" or the
"Company"), a specialty pharmaceutical company with a focus on
Omega-3 therapies for cardiovascular disease ("CVD") and overall
health and the University Hospital of Strasbourg, are pleased to announce today
that POMEGA trial chief investigator Dr. Yannick Georg has been designated laureate of
the EUR 30,000 young researcher
French Interregional Clinical Research and Innovation (GIRCI Est)
Award.
Dr. Yannick Georg, surgeon in the
Department of Vascular Surgery and Kidney Transplantation of the
Cardiology Competence Centre of the University Hospital of
Strasbourg (Director: Prof.
Nabil Chakfé), is conducting the
POMEGA clinical trial jointly with Prof. Oliver Morel (Department of Cardiology), Prof.
Bernard Gény (Department of
Physiology and Functional Explorations of the Thoracic Pathology
Competence Centre) and Professors Valérie Schini-Kerth and
Florence Toti (Faculty of
Pharmacy).
The POMEGA Trial
The POMEGA trial is a prospective, randomized double blinded
clinical trial comparing the therapeutic impact of a novel omega-3
formulation (VASCAZEN®) vs. placebo in patients
diagnosed with asymptomatic stenosis scheduled for carotid
endarterectomy. Biochemical composition of atheromatous plaques and
changes in blood composition will be investigated. The POMEGA trial
will start in the second quarter of 2015. It was approved by the
national French regulatory authority, l'Agence Nationale de la
Sécurité du Médicament (ANSM) on January 13,
2015.
Patient Benefit
The expected benefit of VASCAZEN® is twofold:
reduce the intraplaque concentration of procoagulant and
proathérosclérotic microparticles and obtain a rationale for
broadening the therapeutics options to stabilize these atheromatous
plaques.
Recognition of Clinical Excellence of the Department of
Vascular Surgery and Kidney Transplantation
Prof. Nabil Chakfé and Dr.
Yannick Georg are particularly proud
and pleased that their Department was selected as a reference site.
"This award underscores the recognition of our Department's
participating in multidisciplinary research and our strong
commitment towards innovation," Prof. Chakfé and Dr. Georg
said.
"We are very pleased that the French authorities have recognized
the innovative character of the clinical research performed by Dr.
Georg and his colleagues at the University Hospital of Strasbourg and we are enthusiastic about
starting our future clinical collaboration in France with the Department of Vascular Surgery
and Kidney Transplantation of Prof. Nabil
Chakfé in Strasbourg," Dr.
George Jackowski, founder and CSO of
Pivotal Therapeutics Inc., said.
About University Hospital of Strasbourg
Ranking among the first-in-class university hospital centres
(CHU) in France, the University
Hospital of Strasbourg (HUS) is
recognized for the quality of medical treatment given to its
patients, its excellence in clinical research and innovation and
its position as a leader in initial and permanent training and
teaching for health professionals in the Eastern French region of
Alsace.
Its strong collaboration with the University of Strasbourg as recognized internationally by
the Shanghai classification serves
as an example and a reference within the French hospital-university
environment.
Research is at the very heart of the Strasbourg University
Hospital as evidenced by its Hospital-University Institute (IHU)
specialized in minimally invasive surgery guided by imaging
techniques, its 21 certified groups (CNRS, INSERM, University of
Strasbourg) and its partnership
with four LabEx (Laboratories of Excellence). The University
Hospital of Strasbourg contributes
to medical progress allowing it to participate in cutting edge and
highly innovative projects to the benefit of the patients.
As a partner with the Centre Against Cancer Paul Strauss, the
University Hospital of Strasbourg
created the Regional Cancer Institute, a vehicle for the
cooperation of the public efforts in oncology research and
education in Strasbourg and the
region. Many projects like the medical technology platform, the
Regional Cancer Institute, international and European collaborative
projects demonstrate the ambitious policy of the University
Hospital of Strasbourg not only in
favor of the Alsatian population and beyond but also with regard to
novel health initiatives and projects at national, European and
international levels.
About Pivotal Therapeutics Inc.
Pivotal Therapeutics is a publicly traded Canadian
(OTCQX:PVTTF; CSE:PVO) specialty pharmaceutical company with
a focus on cardiovascular disease and overall health. Pivotal
Therapeutics' lead product VASCAZEN® is a
prescription only medical food (a category regulated by the US
FDA), commercially available throughout the United States, formulated to meet the
dietary Omega-3 deficient needs of patients with cardiovascular
disease through elevating Eicosapentaenoic acid (EPA) and
Docosahexaenoic acid (DHA) to levels associated with reduced risk
of cardiovascular complications.
OMAZEN® is currently commercialized in
Canada as a high purity (>90 %)
patented Omega-3 formulation.
BENEFISHIAL™ is the first in a series of non-prescription
nutraceutical products with compositions and formulations specific
to the needs of people likely to benefit from a nutritional
supplement containing highly pure Omega-3.
Disclosure Notice
The information contained in this document is as of
April 7, 2015. This press release
contains forward-looking statements. Such forward-looking
statements are subject to a number of risks, assumptions and
uncertainties that could cause Pivotal's actual results to differ
materially from those projected in such forward-looking statements.
These statements can be identified by the use of words such as
"will", "anticipate", "estimate", "expect", "project", "forecast",
"intend", "plan", "believe", "project", "potential", and similar
expressions with any discussion of future operating or financial
performance or events. In particular, factors that could cause
actual results to differ materially from those in forward looking
statements include the following: Pivotal's inability to obtain
additional financing on acceptable terms; growth in costs and
expenses; inability to compete with others who provide comparable
products; risk that the Company's products will not gain widespread
market acceptance; risks relating to the Company's ability to
maintain its CSE listing. Forward-looking statements speak only as
of the date made and are not guarantees of future performance. The
Company undertakes no obligation to publicly update or revise any
forward-looking statements contained in this document as a result
of new information or future events or developments. The CSE has
not reviewed and does not accept responsibility for the adequacy or
accuracy of this information.
SOURCE Pivotal Therapeutics Inc.