Oxygen Biotherapeutics
focuses on developing and commercializing drugs for critical care patients. It
has one candidate in phase IIb clinical trials in Switzerland and Israel for
use in treating traumatic brain injury (TBI). The company had an important move
earlier with a significant acquisition. The market reaction to this acquisition
was phenomenal. Let’s take a look at why the company moved up so quickly.
Share Price Soars By 300%
The stock increased in value
from just under two dollars to a high point of just over eight dollars. The
company had a definitive agreement to acquire certain assets of the privately
held company Phyxius Pharma. This was a significant acquisition because it
included the US and Canadian development and commercialization rights to
levosimedan.
This is the reason investors
reacted so favorably on October 31, 2013. The Duke Clinical Research Institute
published findings of numerous clinical trials that evaluated the use of
levosimedan in patients undergoing heart surgery. These were the findings:
• Associated with reduced
mortality
• Reduced adverse events
such as heart attacks during and after operations
• The same findings were
found in patients with reduced heart functionality undergoing heart surgery
Levosimedan is a calcium
sensitizer developed for intravenous use in hospitalized patients for acute
decompensated heart failure and is currently approved for use in more than 50
countries.
The FDA has “Fast Tracked”
levosimedan for the reduction of morbidity and mortality in cardiac surgery
patients at risk for developing Low Cardiac Output syndrome. Phyxius Pharma’s
Phase 3 protocol design under Special Protocol Assessment (SPA) was also agreed
to by the FDA. This means that a single successful trial will be sufficient to
support approval of levosimedan.
Phase 3 Levosimedan Trial
Protocols Announced
The Phase 3 trial will be
conducted in about 50 major cardiac surgery centers in North America, enrolling
patients that are undergoing coronary artery bypass grafts or mitral valve surgery.
Any of these patients will be at risk for developing low cardiac output
syndrome. The company expects to enroll approximately 760 patients.
The trial is event driven
which means it will be stopped when the “event rate” is higher or lower than
expected.
As the year begins, the
company will be focused on conducting its studies in the clinical development
process to establish a foundation for development, explore collaborations and
partnerships to accelerate future development, and gain regulatory approval for
development and commercialization of the company’s products here in the United
States.
Levosimedan is the most
promising drug the company has presently, but there is another one in the
background that may prove helpful.
Clinical Trial of Oxycyte
PFC
The company has one product
candidate in Phase IIb clinical trials. Oxycyte PFC emulsion is on trial in
Switzerland and Israel for treating traumatic brain injuries.
Phase I and IIa studies were
conducted in the United States and the Phase IIb was filed with the FDA in the
spring of 2008 but remains on “clinical hold” by the FDA due to questions the
agency raised.
It received $2.07 million
through a cost reimbursement award from the U.S. Army to conduct safety
preclinical studies of Oxycyte PFC emulsion that will address the FDA’s
questions.
The studies examined the
effect of Oxycyte on the immune system, platelet function and the distribution.
It also studied the safety and efficacy of platelet transfusion. The results of
the studies should support the safety profile of Oxycyte PFC emulsion for the
FDA.
It seems the market really
likes the acquisition of levosimedan and its possibility of a revenue
generating drug for OXBT. Because the drug is fast tracked, investors are
expecting results and answers to come very soon.
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