Company to support a 500+ patient study
assessing benefit of levosimendan in septic shock patients
Oxygen Biotherapeutics, Inc. (NASDAQ: OXBT) a specialty
pharmaceutical company focused on developing and commercializing a
portfolio of products for the critical care market, today announced
a collaboration with Imperial College London to provide
supplemental funding to support the accelerated enrollment and
completion of the ongoing LeoPARDS Trial (Levosimendan for the
Prevention of Acute oRgan Dysfunction in Sepsis) awarded by the
Efficacy and Mechanism Evaluation (EME) Programme and funded by the
Medical Research Council (MRC) and managed by the National
Institute for Health Research (NIHR) on behalf of the MRC-NIHR
partnership. Oxygen is also currently preparing to initiate a Phase
3 trial in the United States during the third quarter to evaluate
levosimendan in cardiac surgery patients at risk of developing low
cardiac output syndrome (LCOS).
The LeoPARDS trial is designed to determine whether levosimendan
reduces the incidence and severity of acute organ dysfunction in
adult patients who have septic shock, as well as evaluate its
safety profile. Septic shock represents an area of very high unmet
medical need, as the condition is associated with high mortality,
morbidity and critical care costs. Given the limited treatment
options that exist and the prior research data regarding the
potential benefits of levosimendan in septic shock patients, the
EME Programme awarded funding of the LeoPARDS trial, which will be
led by Imperial College London.
“Early preclinical and clinical studies of levosimendan have
demonstrated potentially unique beneficial effects on heart
performance and organ perfusion in patients suffering from septic
shock, with a differentiated mechanism that could avoid the
pitfalls of commonly used adrenaline-like drugs,” said Dr. Anthony
Gordon, chief investigator of the LeoPARDS trial and a critical
care physician and septic shock expert at Imperial College London.
“We are grateful to have the additional support from Oxygen
Biotherpaeutics, a leader in the continued development of
levosimendan, to help us accelerate trial enrollment as we work
toward providing these patients with additional therapeutic
options.”
“We are very pleased to support the LeoPARDS trial and to
accelerate the timeline for results from this important study in
septic shock patients,” said John Kelley, CEO of Oxygen
Biotherapeutics. “Past clinical trials indicate that levosimendan
may offer septic shock patients important clinical benefits, and
our collaboration with Imperial College London on this trial is
just one example of how we intend to utilize the significant
European clinical experience with levosimendan across a wide range
of critical care conditions to guide our development strategy in
the United States. While our focus remains on our upcoming Phase 3
trial in cardiac surgery patients at risk of developing LCOS, we
are currently monitoring a number of ongoing trials that are
designed to evaluate levosimendan in indications such as high risk
non-cardiac surgery, acute kidney injury, and acute respiratory
failure, which could all represent attractive areas for further
development to help patients with critical care conditions of high
unmet need.”
The LeoPARDS trial began patient enrollment in the first quarter
of 2014 with significant interest and trial enrollment, but the
existing funding meant several interested clinical trial sites were
unable to participate. Oxygen has agreed to provide supplemental
funding of $500,000 through an unrestricted grant, which will allow
additional sites to enroll patients more quickly.
The randomized, double-blind, placebo-controlled, multi-centre
trial design is based on previously conducted small clinical trials
which indicate that levosimendan may provide unique and important
clinical benefits to septic shock patients through improved heart
function and organ perfusion. The study protocol for this 500-plus
patient trial was recently published and is available at:
http://www.trialsjournal.com/content/15/1/199
About Levosimendan
Levosimendan is a calcium sensitizer developed for intravenous
use in hospitalized patients with acutely decompensated heart
failure. It was discovered and developed by Orion Pharma, Orion
Corporation of Espoo Finland, and is currently approved in over 50
countries for this indication and not available in the United
States. Oxygen Biotherapeutics recently acquired the North American
rights to develop and commercialize levosimendan from Phyxius
Pharma. The United States Food and Drug Administration (FDA) has
granted Fast Track status for levosimendan for the reduction of
morbidity and mortality in cardiac surgery patients at risk for
developing Low Cardiac Output Syndrome (LCOS). In addition, the FDA
has agreed to the Phase 3 protocol design under Special Protocol
Assessment (SPA), and provided guidance that a single successful
trial will be sufficient to support approval of levosimendan in
this indication.
About LeoPARDS Trial
Sepsis is a life-threatening condition that causes the blood
pressure to fall dangerously, compromising blood flow to vital
organs such as the liver and kidney. It is the leading cause for
admission to an intensive care unit in the UK, accounting for about
30% of all admissions. Despite advances in treatment around 40% of
such patients unfortunately die.
Conventionally, adrenaline-like drugs are used to support a
patient’s blood pressure but they can have serious side effects.
Levosimendan is a new type of drug that is currently used to treat
patients with advanced heart failure. It works in a different
manner to adrenaline-like drugs, potentially avoiding some of these
side effects. It may also improve the blood flow to vital organs.
In small scale clinical trials in patients with sepsis who have
been given levosimendan significant improvements were seen in the
function of the heart, kidneys and other organs.
This trial is designed to investigate whether giving
levosimendan to ICU patients suffering from sepsis can improve the
function of different organ systems and potentially improve the
outcome for sepsis patients
About NHS and the National Institute for Health
Research
1. The Efficacy and Mechanism Evaluation Programme supports
later-phase “science-driven” clinical trials and evaluative
studies, which seek to determine whether a health intervention
(e.g. a drug, diagnostic technique or device) works and in some
cases how or why it works.
2. The Efficacy and Mechanism Evaluation Programme
(www.nets.nihr.ac.uk/programmes/eme) is funded by the MRC and NIHR,
with contributions from the CSO in Scotland, NISCHR in Wales and
the HSC R&D Division, Public Health Agency in Northern Ireland.
It is managed by the NIHR Evaluation, Trials and Studies
Coordinating Centre (NETSCC) based at the University of
Southampton.
3. The National Institute for Health Research (NIHR) is funded
by the Department of Health to improve the health and wealth of the
nation through research. Since its establishment in April 2006, the
NIHR has transformed research in the NHS. It has increased the
volume of applied health research for the benefit of patients and
the public, driven faster translation of basic science discoveries
into tangible benefits for patients and the economy, and developed
and supported the people who conduct and contribute to applied
health research. The NIHR plays a key role in the Government’s
strategy for economic growth, attracting investment by the
life-sciences industries through its world-class infrastructure for
health research. Together, the NIHR people, programmes, centres of
excellence and systems represent the most integrated health
research system in the world. For further information, visit the
NIHR website (www.nihr.ac.uk).
4. The Medical Research Council has been at the forefront of
scientific discovery to improve human health. Founded in 1913 to
tackle tuberculosis, the MRC now invests taxpayers’ money in some
of the best medical research in the world across every area of
health. Twenty-nine MRC-funded researchers have won Nobel prizes in
a wide range of disciplines, and MRC scientists have been behind
such diverse discoveries as vitamins, the structure of DNA and the
link between smoking and cancer, as well as achievements such as
pioneering the use of randomised controlled trials, the invention
of MRI scanning, and the development of a group of antibodies used
in the making of some of the most successful drugs ever developed.
Today, MRC-funded scientists tackle some of the greatest health
problems facing humanity in the 21st century, from the rising tide
of chronic diseases associated with ageing to the threats posed by
rapidly mutating micro-organisms. www.mrc.ac.uk
This article presents independent research funded by the
National Institute for Health Research (NIHR). The views expressed
are those of the author(s) and not necessarily those of the NHS,
the NIHR or the Department of Health.
The National Health Service (NHS) is the publicly funded
healthcare system for England. It is the largest and the oldest
single-payer healthcare system in the world. Primarily funded
through the general taxation system, the system provides healthcare
to every legal resident in the United Kingdom, with most services
free at the point of use.
About Oxygen Biotherapeutics
Oxygen Biotherapeutics, Inc. is a specialty pharmaceutical
company focused on developing and commercializing a portfolio of
products for the critical care market. The company recently
acquired the North American rights to develop and commercialize
levosimendan, and the United States Food and Drug Administration
(FDA) has granted Fast Track status for levosimendan for the
reduction of morbidity and mortality in cardiac surgery patients at
risk for developing Low Cardiac Output Syndrome (LCOS). The company
plans to start a Phase 3 trial with levosimendan in that indication
during the third quarter of 2014, and has also developed a
proprietary perfluorocarbon (PFC) therapeutic oxygen carrier called
Oxycyte® that is currently in clinical and preclinical studies for
intravenous delivery for indications such as traumatic brain
injury, decompression sickness and stroke.
Caution Regarding Forward-Looking Statements
This news release contains certain forward-looking statements by
the company that involve risks and uncertainties and reflect the
company’s judgment as of the date of this release. The
forward-looking statements are subject to a number of risks and
uncertainties, including, but not limited to matters beyond the
company's control that could lead to delays in the clinical
studies, delays in new product introductions and customer
acceptance of these new products, and other risks and uncertainties
as described in the company’s filings with the Securities and
Exchange Commission, including in its quarterly report on Form 10-Q
filed on March 17, 2014, and annual report on Form 10-K filed on
July 29, 2014, as well as its other filings with the SEC. The
company disclaims any intent or obligation to update these
forward-looking statements beyond the date of this release.
Statements in this press release regarding management’s future
expectations, beliefs, goals, plans or prospects constitute
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995.
Stern Investor RelationsJesse Baumgartner,
212-362-1200jesse@sternir.com
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