Oxygen Biotherapeutics reported late Thursday that it has halted Phase 2 trial for Oxycyte, the Morrisville company’s treatment for traumatic brain injury.
“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 Ronald Blanck, chairman of Oxygen’s board, in a statement. "We will be considering strategic alternatives for Oxycyte moving forward.”
Oxygen had partnered with Wilmington-based PPD to complete the second phase of clinical trials of Oxycyte.
The company will now focus on the development of levosimendan, a drug to prevent and treat cardiac surgery patients at risk of developing low cardiac output syndrome, or LCOS. Oxygen acquired the rights to the drug in October 2013.
Levosimendan is now in Phase 3 trials, the final stage of testing required before the company can seek regulatory approval to put the drug on the market. Oxygen believes Levosimendan targets a $600 million market in the U.S.
Levosimendan has been granted fast-track status by the Food and Drug Administration, a designation that accelerates the review process for drugs that have the potential to offer significant improvement in treatment compared to products already on the market.
Oxygen’s stock was flat in early trading Friday. The stock, which opened at $4.06, is down 9 percent this year.