Shares of Oxygen Biotherapeutics climbed more than 3% to $5.55 per share on Mar 31 following the receipt of a letter from the U.S. Food and Drug Administration’s (FDA) to lift the clinical hold on the company’s Oxycyte development program.
The FDA informed the company about its decision through written communication. The decision to lift the clinical hold was originally communicated by the FDA during a conference call on Feb 28, 2014. Shares of the company had risen substantially at that time. The written communication reiterated the U.S. regulatory body’s stance.
The FDA lifted the clinical hold following the completion of review of data from two series of animal studies in treating patients with traumatic brain injury (TBI). The data was submitted by Oxygen Biotherapeutics in Sep 2013. The U.S. regulatory body, while communicating the decision to the company said that all its concerns on the matter were addressed by Oxygen Biotherapeutics.
While clinical development work was suspended in the U.S. during the clinical hold, Oxygen Biotherapeutics continued clinical development activity for the three-cohort phase II b study on Oxycyte, a perfluorocarbon (PFC) therapeutic oxygen carrier, in ex-U.S. sites. Following the withdrawal of the clinical hold, Oxygen Biotherapeutics has resumed the clinical development of Oxycyte for TBI in the U.S.
The company’s lead pipeline candidate is levosimendan. The candidate will be evaluated in a double blind, randomized, placebo controlled phase III study (n~760) for low cardiac output syndrome in cardiac surgery patients.
The study will be conducted under the FDA’s Special Protocol Assessment (SPA) program. It will evaluate if levosimendan administered before and during operation can bring down the incidence of morbidity and mortality in patients. We believe investor focus will remain on development of the candidates in Oxygen Biotherapeutics’ pipeline.
Oxygen Biotherapeutics carries a Zacks Rank #3 (Hold). Better-ranked stocks in the medical sector include Alexion Pharmaceuticals, Inc. (ALXN - Free Report) , GileadSciences (GILD - Free Report) and Alkermes (ALKS - Free Report) . All 3 stocks carry a Zacks Rank #1 (Strong Buy).