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Levosimendan Development

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Oxygen Biotherapeutics Announces Collaboration with Imperial College London to Accelerate Enrollment of LeoPARDS Trial

Company to support a 500+ patient study assessing benefit of levosimendan in septic shock patients

Wednesday, August 6, 2014 8:00 am EDT

Public Company Information:

MORRISVILLE, N.C.--(BUSINESS WIRE)--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). more..

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Levosimendan- Phase 3

Levosimendan is under development in North America for reduction in morbidity and mortality of cardiac surgery patients at risk of low cardiac output syndrome (LCOS). The FDA has granted Fast Track status for levosimendan and has agreed to our Phase 3 clinical trial protocol under a Special Protocol Assessment (SPA). The FDA has provided guidance that a single successful trial will be sufficient to support approval of levosimendan in this indication.

The Phase 3 clinical trial will study if levosimendan administered before and during surgery will reduce the incidence of morbidity and mortality in cardiac surgery patients at risk. There is substantial scientific evidence for the use of levosimendan in cardiovascular surgery, with over 25 published articles in peer reviewed journals and evidence of mortality reduction in some cardiac surgery trials of more than 50%.

Oxycyte® – Phase 2

Phase 1 and 2a clinical development studies were conducted in the United States. The ongoing clinical trial in traumatic brain injury (TBI) is a double-blind, placebo–controlled, dose-escalation study. The first cohort of patients has been successfully completed in Israel and Switzerland with an independent data safety monitoring board approving advancement to the next higher dose. Enrollment in the second cohort, which began in May 2013, is progressing. On February 28, 2014, following submissions of animal data to address the FDA’s prior clinical hold, the FDA announced in a meeting with the Company that we have satisfactorily addressed their safety concerns. The clinical hold was formally lifted on March 7, 2014 when we received written confirmation from the FDA”.