WOODBRIDGE, ON, June 4, 2015 /PRNewswire/ - Pivotal
Therapeutics Inc. (OTCQX: PVTTF) (CSE: PVO), a specialty
pharmaceutical company with a focus on Omega-3 therapies for
cardiovascular disease (CVD) and overall health, announced today
the enrollment of the first patient in Pivotal's POMEGA
Phase IIa clinical trial with PVT-100.
The POMEGA Phase IIa clinical trial is a double-blinded
placebo controlled study in over 100 patients scheduled to undergo
vascular invasive surgery for carotid endarterectomy at the
University Hospital of Strasbourg,
France. Patients shall be randomized to receive either
Pivotal's uniquely formulated drug candidate PVT-100 or a
placebo, for six consecutive weeks. The composite primary endpoint
of the trial consists of histomorphological, biochemical and
immunological status of the vascular plaque.
The trial entitled "Impact of an optimized Omega 3
formulation on the biochemical and histopathological composition of
atheromatous plaques in patients to undergo carotid
endarectomy" is sponsored by the University Hospital of
Strasbourg and authorized by the
French national supervisory authority ANSM, the equivalent to the
U.S. FDA. This trial is coordinated by an interdisciplinary team of
six vascular surgeons and twenty health professionals and monitored
by the French health authorities via the national Clinical Trial
Management System (CTMS). This system supervises all therapeutic
clinical trials performed in France. Product packaging, supply and trial
logistics including on site quality control/compliance monitoring
is performed by German drug safety corporation Preventor µTBC
GmbH.
"We are very excited about the enrollment of the first patient
in the POMEGA trial," stated Dr. George Jackowski, Co-Founder and Chief
Scientific Officer. "Positive results of the trial will allow
for new indications for prescription Omega-3 formulations,
initiating novel therapeutic regimes beyond treating patients with
very high triglycerides."
About Pivotal Therapeutics Inc.
Pivotal Therapeutics is a publicly traded (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 specially formulated for the dietary management of
Omega-3 deficiency in patients with cardiovascular disease through
elevating Eicosapentaenoic acid (EPA) and Docosahexaenoic acid
(DHA) to levels associated with reduced risk of cardiovascular
complications. OMAZEN® is a pharmaceutical
grade Omega-3 providing over 90% pure Omega-3 in each capsule for
the maintenance of good health. OMAZEN® is a
patented product available for sale and distribution in
Canada for the professional
market. BeneFishial™ is the first product in Pivotal's new
nutraceutical product line, which has been specifically designed to
be sold in the OTC direct to retail or direct to consumer markets.
The Company's product line is being expanded to include its first
drug candidate PVT-100 and a point of care diagnostic
OmegaSTAT™. PVT-100 utilizes
VASCAZEN®'s unique formulation for the
stabilization of vulnerable plaque in patients undergoing carotid
endarterectomy. OmegaSTAT™ is a rapid format
point-of-care (POC) diagnostic test being developed to measure
Omega-3 deficiency.
Disclosure Notice
The information contained in this
document is as of June 4, 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.
