Oxygen Biotherapeutics Announces Halt of Oxycyte Phase IIb Traumatic Brain Injury Trial
September 11 2014 - 5:30PM
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
that the Company, with unanimous approval from the Board of
Directors, has elected to stop the current Phase IIb trial for its
Oxycyte drug candidate and consider strategic alternatives for the
program moving forward. The company will review the data generated
on the patients enrolled in the trial to date.
“With the difficulties we have had enrolling patients at the
current Phase IIb clinical sites for Oxycyte, the Oxygen Board of
Directors and management team has decided that completing this
trial in a reasonable period of time is not feasible,” said Dr.
Ronald Blanck, Chairman of the Oxygen Board of Directors. "We will
be considering strategic alternatives for Oxycyte moving
forward.”
Oxycyte, a proprietary perfluorocarbon (PFC) therapeutic oxygen
carrier, was in clinical and preclinical studies for intravenous
delivery in indications such as traumatic brain injury,
decompression sickness and stroke. The current Phase IIb study was
evaluating the safety and tolerability of Oxycyte in patients with
severe non-penetrating traumatic brain injury (STOP-TBI).
The Company will be focusing resources on its lead critical care
product, levosimendan, a calcium sensitizer in Phase 3 development
in the United States for the reduction of morbidity and mortality
in cardiac surgery patients at risk for developing Low Cardiac
Output Syndrome (LCOS).
In July 2014, Oxygen initiated a Phase 3 trial in the United
States to evaluate levosimendan in cardiac surgery patients at risk
of developing LCOS. The FDA has granted Fast Track status for
levosimendan in this indication.
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 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
initiated a Phase 3 trial with levosimendan in that indication in
July 2014.
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 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.
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 timing or success
of terminating the Oxycyte trial, the availability, on favorable
terms or at all, of strategic alternatives to the Oxycyte program,
matters beyond the company's control that could lead to delays in
the levosimendan 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
annual report on Form 10-K filed on July 29, 2014, 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.
Stern Investor Relations, Inc.Jesse Baumgartner,
212-362-1200jesse@sternir.com
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