Phyxius Pharma in Conjunction with Oxygen Biotherapeutics Announces New Evidence That Levosimendan Can Reduce Mortality in Heart

  Phyxius Pharma in Conjunction with Oxygen Biotherapeutics Announces New
  Evidence That Levosimendan Can Reduce Mortality in Heart Surgery Patients

  Study ResultsSupport theRecently Announced Phase 3 Clinical Trial Design
    which has been Approved by FDA Under Special Protocol Assessment (SPA)

Business Wire

MORRISVILLE, N.C. & CHESTER, N.J. -- October 30, 2013

Phyxius Pharma, Inc. and Oxygen Biotherapeutics, Inc., (NASDAQ: OXBT), today
announced that researchers at the Duke Clinical Research Institute (DCRI),
part of the Duke University School of Medicine, recently published findings of
a meta-analysis of multiple clinical trials that evaluated the use of
levosimendan in patients undergoing heart surgery. The study aggregated and
analyzed results from 14 independent clinical trials with a total of 1,155
patients. The published results showed that levosimendan was associated with
reduced mortality (death) and other adverse outcomes including heart attacks
during and after operation in patients with reduced heart function undergoing
heart surgery. This research was recently published in the Journal of
Cardiothoracic and Vascular Anesthesia as an "in Press" online version of the
publication that precedes the final publication. A link to the online version
of the publication is available here:
http://www.jcvaonline.com/article/S1053-0770(13)00171-7/abstract.

Oxygen Biotherapeutics has a Definitive Agreement to acquire certain assets of
Phyxius Pharma, including the U.S. and Canadian development and
commercialization rights to levosimendan. 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 Phyxius Pharma’s 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.

John Alexander, M.D., MHS, Director, Cardiovascular Research, Duke Clinical
Research Institute said, “Our meta-analysis of 14 randomized clinical trials
suggests that levosimendan, in conjunction with standard care in high-risk
cardiac surgery patients with reduced left ventricular function, may reduce
mortality and other adverse outcomes by as much as 50 percent.”

John Kelley, CEO of Phyxius Pharma stated, "These findings are highly
supportive of our definitive Phase 3 trial design which includes mortality,
need for dialysis, peri-operative myocardial infarction, as components of the
primary composite endpoint. With the support of these data and the FDA’s
guidance we have designed a very modest sized and highly cost efficient trial
of 760 patients. This is far smaller than other cardiac trials which typically
require larger patient populations.”

Robert Harrington, M.D. Chairman of the Department of Medicine at Stanford
University stated, “LCOS represents an area of unmet medical need. The results
of this meta-analysis are highly supportive of Phyxius Pharma’s current Phase
3 clinical trial design that intends to evaluate the ability of levosimendan
treatment to prevent LCOS and the associated mortality and morbidity.”

Consistent with the positive meta-analysis findings, the Phase 3 trial is
designed to include low EF (Ejection Fraction) cardiac surgery patients and
evaluates several end points included in the meta-analysis.

About Phyxius Pharma

Phyxius Pharma, Inc. is a privately-held development stage pharmaceutical
company. The company is focused on developing products for use in acute care
settings. The company has licensed North American rights to develop and
commercialize levosimendan from Orion Pharma, Orion Corporation of Espoo,
Finland.

About Levosimendan

Levosimendan is a calcium sensitizer developed for intra-venous use in
hospitalized patients with acutely decompensated heart failure. It is
currently approved in 53 countries for this indication. It is not available in
the United States. It is under development in North America for reduction in
morbidity and mortality of cardiac surgery patients at risk of low cardiac
output syndrome (LCOS).

About Oxygen Biotherapeutics, Inc.

Oxygen Biotherapeutics, Inc. is developing medical products that efficiently
deliver oxygen to tissues in the body. The company has 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.
The company is also developing PFC-based creams and gels for topical delivery
to the skin for dermatologic conditions and potentially wound care.

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, the
likelihood of the consummation of the Phyxius transaction, as well as the
successful integration of Phyxius into the Company, delays in new product
introductions and customer acceptance of these new products, and other risks
and uncertainties as described in our filings with the Securities and Exchange
Commission, including in the current Form 10-Q filed on September 17, 2013,
and our annual report on Form 10-K filed on June 26, 2013, as well as other
filings with the SEC. The company disclaims any intent or obligation to update
these forward-looking statements beyond the date of this release. This caution
is made under the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995.

Contact:

IRTH Communications
Robert Haag, 1-866-976-IRTH (4784)
Email Contact
 
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