Oxygen Biotherapeutics, Inc. Shares Gyrate After Halting Mid-Stage Brain Injury Trial
September 12, 2014
By Mark Terry, BioSpace.com Breaking News Staff
Trading in shares in Oxygen Biotherapeutics fell lower Friday after the company announced earlier this week it is stopping its Phase IIb clinical trial early for its brain injury drug Oxycyte.
The company said in now plans to change direction and focus on another lead product, levosimendan.
Oxygen Biotherapeutics announced it had prematurely ended the clinical trials because it had difficulty enrolling patients.
“With the difficulties we have had enrolling patients at the current Phase 2b 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 Oxygen Biotherapeutics Chairman Ronald Blanck in a statement. “We will be considering strategic alternatives for Oxycyte moving forward.”
Oxygen Biotherapeutics Inc. shares took a hit at the news, closing down 13.8% on Thursday. The company’s been on something of a rollercoaster this year, with stock prices ranging from $1.19 to $11.40.
Still, Oxygen Biotherapeutics had some good news in early August, when it announced a collaboration with Imperial College London to provide supplemental funding to its ongoing LeoPARDS Trial (Levosimendan for the Prevention of Acute oRgan Dysfunction in Sepsis).
The company has indicated it will now focus on the levosimendan trials. Levosimendan is a calcium sensitizer, currently in Phase 3 development in the U.S. to study the drug for the decrease of morbidity and mortality in cardiac surgery patients at risk for developing Low Cardiac Output Syndrome (LCOS). The U.S. Food and Drug Administration granted the drug fast track status in July.
Oxycyte is a perflurocarbon (PFC) oxygen carrier. The Phase 2b study it was entered in was for intravenous delivery in patients with traumatic brain injury, decompression sickness and stroke. The drug carries as much as five times the amount of oxygen as hemoglobin, which would allow it to carry significant more oxygen to the brain and lungs, as well as carry carbon dioxide to the lungs for elimination.
Other potential uses for the drug include sickle cell crisis, trauma, wound care, acute respiratory distress syndrome, diabetic wound and ulcers.
Oxycyte has already undergone Phase 1 and 2a clinical studies in the U.S. Human trials have been completed in Israel and Switzerland. A second cohort of patients began enrollment in May 2013. Animal data was submitted to the FDA and at the end of February 2014, the FDA announced they were satisfied with their safety concerns and a clinical hold was formally lifted on March 7.