Pivotal Therapeutics VASCAZEN® - Meets Primary Endpoint in Reveal Trial - Top Line Results Accepted for Presentation at t...
09 Aprile 2013 - 2:45PM
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Pivotal Therapeutics VASCAZEN® - Meets Primary Endpoint in Reveal
Trial - Top Line Results Accepted for Presentation at the American
Heart Association's ATVB 2013 Scientific Sessions
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Pivotal Therapeutics VASCAZEN® - Meets Primary Endpoint in Reveal
Trial - Top Line Results Accepted for Presentation at the American
Heart Association's ATVB 2013 Scientific Sessions
PR Newswire
WOODBRIDGE, ON, April 9, 2013
WOODBRIDGE, ON, April 9, 2013 /PRNewswire/ - Pivotal
Therapeutics Inc. (OTCQX: PVTTF) (CNSX: PVO), a specialty
pharmaceutical company with a focus on Omega-3 therapies
for cardiovascular disease (CVD) and overall health, is pleased
to
announce that VASCAZEN® met its primary endpoint in the
REVEAL trial. Additionally, VASCAZEN® achieved
statistical significance in various secondary endpoints in
patients presenting with elevated triglycerides (>200mg/dL <
500mg/dL).
The data has been accepted for presentation at the American
Heart
Association's Arteriosclerosis, Thrombosis and Vascular Biology
(ATVB)
2013 Scientific Sessions (ATVB) at Lake
Buena Vista, Florida, USA, May
1-3, 2013.
"This data represents a significant milestone for
VASCAZEN® as a treatment option for the thousands of
people who are Omega-3
defeicient and suffer from elevated triglycerides yet remain below
the
threshold of "very high" triglycerides required for treatment
with
currently available prescription medications" said Dr. George
Jackowski, Chairman and Chief Scientific Officer. "This
landmark study
is among the first that examined Omega-3 deficiency pre and
post
treatment and brings the importance of its correction to the
forefront
as an important part in managing CVD patients. We are very
excited to
be presenting our top line results at this premier conference as
it
attracts the top clinicians and scientists in all areas of
cardiovascular disease focusing on lipids and heart
disease."
Dr. Jackowski gratefully acknowledges the outstanding contribution
of
the Contract Research Organization (CRO), Nutrasource Diagnostics
Inc.,
Guelph, Ontario, Canada, for its
professional execution and management
of the VASCAZEN®-REVEAL trial.
"The CRO trial team has done a superb job in the overall
management of
this pivotal study," stated Dr. Jackowski.
About the Study
The VASCAZEN®-REVEAL trial is a
randomized, double blind, placebo controlled, multi-center
USA based study that enrolled 110
patients. The purpose of the study
was to evaluate the effects of VASCAZEN® in the
correction of Omega-3 deficiency in patients with one or more
risk factors associated with CVD, and to evaluate
VASCAZEN®'s concomitant effects on cardiovascular risk
factors including
triglycerides, VLDL cholesterol, LDL cholesterol, and HDL
cholesterol
among others. The primary efficacy endpoint was the correction of
an
Omega-3 deficiency, and secondary endpoints included positive
effects
on lipid profiles, without any adverse events.
About VASCAZEN
VASCAZEN® is a prescription only Medical Food
specifically formulated for the
dietary management of an Omega-3 deficiency in cardiovascular
patients.
VASCAZEN® is a >90% pure Omega-3 with a
proprietary 6:1 EPA:DHA fatty acid
formulation, protected by a series of both U.S. and foreign
patents. VASCAZEN® is the second to market
prescription only Omega-3 therapy available in
the U.S. and is available by prescription nationwide.
About Pivotal Therapeutics Inc.
Pivotal Therapeutics is a publicly traded (OTCQX: PVTTF) (CNSX:
PVO)
specialty pharmaceutical company with a focus on cardiovascular
disease
and overall health. Pivotal Therapeutics' lead product
VASCAZEN® is a prescription only Medical Food
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.
Disclosure Notice
The information contained in this document is as of April 9, 2013. 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 CSNX 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. CNSX has not reviewed and does not accept
responsibility
for the adequacy or accuracy of this information.
SOURCE Pivotal Therapeutics Inc.
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