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 (NYSE: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 (NYSE: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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