Boston, MA 03/05/2014 (wallstreetpr) – Oxygen Biotherapeutics, Inc. (NASDAQ:OXBT) stocks soared in the market by highs of 35% after the FDA gave the company a nod to continue with clinical trial of its Oxycyte treatment, aimed at treating traumatic brain injury. Food and Drug administration FDA had suspended trials of the brain injury pill in 2008 and also placed a hold on its development. Concerns had been raised over its effectiveness when used on patients with severe brain injury TBI.
Severe brain injury has been known to cause massive drop in body platelet count, as the body goes into overdrive to respond to the severe injuries. The disease is also known to cause up to 52,000 deaths in the US annually. Oxygen Biotherapeutics, Inc. (NASDAQ:OXBT) had received $2.07 million in funding to conduct trials on their pill from the US army.
FDA concerns
FDA major concern with Oxygen Biotherapeutics, Inc. (NASDAQ:OXBT) drug is whether it could result in severe brain bleeding when used on patients with severe brain injuries. Currently there are no drugs in the market to address the condition which is estimated to have a market value of $2 billion as of 2017.
Oxygen Biotherapeutics, Inc. (NASDAQ:OXBT) had already enrolled clinical trials outside the US to find the effectiveness of the pill on patients with severe brain injury. Levosimendan which is the company’s lead drug is being tested in a late stage trial for cardiac surgery patients.
The sudden change of mind by FDA comes at the back of Oxygen Biotherapeutics, Inc. (NASDAQ:OXBT) submitting its animal study in September that addressed the urgency of the approval. The studies had been carried out to find the result of the products interaction with the immune system and the risks its risks on intracerebral hemorrhage. Oxygen Biotherapeutics is currently enrolling patients in Israel for the Phase II-b study.
Oxygen Biotherapeutics, Inc. (NASDAQ:OXBT) was up in Tuesday trading session by 14.52% to close at highs of $7.10.
