Shares of Oxygen Biotherapeutics shot up 30% Tuesday morning after the Morrisville, NC-based biotech announced that the FDA had lifted a clinical hold on Oxycyte, an experimental drug the military has been supporting as a possible treatment for traumatic brain injury.
Oxygen ($OXBT) was required to carry out animal experiments on the drug to satisfy regulators' concerns about the way it interacts with the immune system as well as a risk for brain hemorrhages.
While the FDA's hold on the drug prevented clinical work in the U.S., Oxygen has pushed ahead with a Phase IIb study at sites outside the U.S. The company has been recruiting patients in Israel for the second cohort of a three-cohort trial. The CRO PPD is partnered with Oxygen on the development program.
Oxygen's lead drug is levosimendan, which is in Phase III for low cardiac output syndrome in cardiac surgery patients. A few days ago the company reported that a group of patients experienced improved postoperative renal function in a study of the drug. Oxygen picked up the drug for a little less than $5 million in stock last fall from Phyxius Pharma. John Kelley, co-founder and CEO of Phyxius, was named CEO as part of the deal.
Oxygen has had a turbulent history. A little more than two years ago the company's CEO, Chris Stern, was fired after he allegedly doctored his resume and engineered a scheme aimed at leveraging his position for his own personal gain. Stern rejected the charges at the time.
- here's the release