Oxygen Biotherapeutics Announces Key Details of Phase 3 Trial Protocol for levosimendan
Monday, 06 January 2014 03:08
Jan. 6, 2014 13:00 UTC

Oxygen Biotherapeutics Announces Key Details of Phase 3 Trial Protocol for levosimendan

MORRISVILLE, N.C.--(BUSINESS WIRE)-- Oxygen Biotherapeutics, Inc. (“OBI”) (NASDAQ: OXBT) a specialty pharmaceutical company focused on developing and commercializing a portfolio of products for the critical care market, today announced that the protocol of their phase 3 trial for levosimendan has been published on ClinicalTrials.gov, “Levosimendan in Patients with Left Ventricular Systolic Dysfunction Undergoing Heart Surgery on Cardiopulmonary Bypass.” http://www.clinicaltrials.gov/ct2/show/NCT02025621?term=levosimendan&rank=12

Oxygen Biotherapeutics previously announced that it had selected Duke University’s Duke Clinical Research Institute (DCRI) to conduct the Phase 3 trial of the levosimendan. The Phase 3 trial will be conducted in approximately 50 major cardiac surgery centers in North America. The trial will enroll patients undergoing coronary artery bypass grafts (CABG) and/or mitral valve surgery who are at risk for developing low cardiac output syndrome (LCOS). The trial is a double blind, randomized, placebo controlled study seeking to enroll 760 patients.

The number of patients to be enrolled in the trial is an estimate. This is an event driven trial, and will be stopped when the event rate reaches that identified in the study power calculations. Thus, the number of patients could be less than 760 or higher if the event rate is higher or lower than expected.

The 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.

John Kelley, CEO of Oxygen Biotherapeutics stated: “We are excited to communicate the details of our innovative and efficient trial design , and we look forward to enrolling the first patients in this important trial later this year.”

About Levosimendan

Levosimendan was discovered and developed by Orion Pharma, Orion Corporation of Espoo Finland. Levosimendan is a calcium sensitizer developed for intra-venous use in hospitalized patients with acutely decompensated heart failure. It is currently approved in over 50 countries for this indication and 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). The acquisition brings to Oxygen Biotherapeutics not only the exclusive rights in North America to develop and

commercialize levosimendan for the specific indication of prevention and

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treatment of LCOS, but also the FDA’s approval of Fast Track status for a Phase 3 trial, and the FDA’s SPA which represents agreement with the Phase III clinical trial’s study protocol. The FDA has provided guidance that a single successful trial will be sufficient to support approval of levosimendan in this indication.

About Oxygen Biotherapeutics

Oxygen Biotherapeutics, Inc. is developing medical products for the acute care market. The company recently acquired the North American rights to develop and commercialize 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 a 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. The company also 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.

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 finalization of definitive agreements with DCRI, 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 December 17, 2013, 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.


IRTH Communications
Robert Haag, 1-866-976-4784

Source: Oxygen Biotherapeutics, Inc.

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