MORRISVILLE, N.C.--(BUSINESS WIRE)-Oxygen Biotherapeutics, Inc. (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/
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 Phase 3 LEVO-CTS Clinical Trial
The Phase 3 LEVO-CTS trial is a double-blind, randomized, placebo-controlled study that will evaluate if levosimendan administered before and during cardiac surgery can reduce the incidence of LCOS and associated morbidity and mortality. The trial is seeking to enroll 760 patients undergoing coronary artery bypass grafts (CABG) and/or mitral valve surgery that are at risk for developing LCOS.
Duke University’s Duke Clinical Research Institute (DCRI) will conduct the Phase 3 trial, which will take place in approximately 50 major cardiac surgery centers in North America. The trial is event-driven, and protocol includes a review of the control arm event rate for the first 200 patients randomized in the trial. The study population can be enriched to a higher percentage of patients with a greater degree of left ventricular dysfunction to increase the control event rate. Two interim analyses will test for efficacy or futility after 50% and 70% of the planned primary endpoint events have been recorded.
The protocol for this trial has been published on ClinicalTrials.gov.
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, matters beyond the company’s control that could lead to delays in the clinical study, 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 June 26, 2013, 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.
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