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Oxygen Biotherapeutics Highlights Recent Publicans Showing Potential Benefits of Levosimendan

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Oxygen Biotherapeutics Announces Formation of Steering Committee for Phase 3 LEVO-CTS Trial of Levosimendan

Oxygen Biotherapeutics, Inc. (NASDAQ: OXBT) a specialty pharmaceutical company
focused on developing and commercializing a portfolio of products for the
critical care market, today highlighted three recent review articles examining
the current clinical use of levosimendan and its potential to address a wide
range of critical care conditions.

Oxygen is 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).

“We are encouraged by these recent scientific publications, which continue to
support our belief that levosimendan may offer unique and valuable benefits in
a broad range of critical care conditions that represent areas of high unmet
medical need – including cardiac surgery, but also extending to additional
indications such as cardiogenic shock, high-risk non-cardiac surgery, sepsis,
acute kidney injury, and renal dysfunction and failure,” said John Kelley, CEO
of Oxygen Biotherapeutics. “While enrollment of our upcoming Phase 3 LEVO-CTS
cardiac surgery trial remains our primary and immediate focus, these review
articles highlight the broader potential of levosimendan and the opportunity
we have to utilize the significant European clinical experience to date to
inform our future development strategy in the United States.”

Summaries of the review articles are as follows:

* “Levosimendan: current data, clinical use and future development,” Heart,
Lung and Vessels; Nieminen, et al. The article highlights the clinical
profile of levosimendan in acute heart failure, past studies of the drug
in additional therapeutics applications including cardiac surgery, and
points to “a range of beneficial haemodynamic and cardio protective
effects, and a favourable influence on clinical outcomes.” The article
also points to preliminary positive observations in additional conditions
that require inotropic support – such as right ventricular failure,
cardiogenic shock, septic shock, and Takotsubo cardiomyopathy. A link to
the review article is provided here:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3868185/
* “Preoperative Levosimendan. A New Way for Organoprotection,” Current
Pharmaceutical Design; Guerrero, et al. The article recommends the use of
levosimendan preoperatively for cardiac surgery patients. The review also
highlights the unique triple mechanism of action of levosimendan –
sensitizing calcium channels in cardiac myofilaments; opening the
ATP-sensitive potassium channels in smooth muscle cells; opening the
ATP-sensitive potassium channels of mitochondria of cardiac cells. The
authors highlight that “through this triple mechanism, levosimendan
increases the contractile force of the cardiac muscle fibers, cause both
peripheral arterial and venous vasodilation, and exerts a cardio
protective effect against ischemia.” A link to the abstract of the review
article is provided here: http://www.ncbi.nlm.nih.gov/pubmed/24669969
* “Levosimendan in Critical Illness: A Literature Review,” Journal of
Clinical Medicine Research; Pierrakos, et al. The article provides an
overview of levosimendan in a range of critical care situations where
cardiac failure is a concern; these conditions would include cardiac
surgery, cardiogenic shock, sepsis, renal dysfunction and renal failure.
The authors state that “available evidence suggests that levosimendan is a
safe treatment option in critically ill patients and may reduce mortality
from cardiac failure,” pending well-designed randomized controlled trials
to validate or refute these preliminary conclusions. A link to the review
article is provided here:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3935527/

Posted-In: News FDA Press Releases

 

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