Oxygen Biotherapeutics, Inc has filed a response to the FDA's request for information and that the filing also includes a synopsis of the company's revised protocol for a phase-II dose escalation clinical trial of Oxycyte in Traumatic Brain Injury (TBI). Oxycyte is the company's perfluorocarbon (PFC) therapeutic oxygen carrier.

The company also announced that it has initiated safety and toxicity trials for the first Oxycyte wound-treatment indication.

In action items following the company's meeting with the FDA on Oct. 22, 2008, the agency requested further information and data about thrombocytopenia - low platelet count that can lead to impaired blood clotting and spontaneous bleeding - in the nine patients who were treated in a phase-IIa TBI study.

"What's interesting is that when we went back through the complete treatment and hospitalization records of those patients, we found that thrombocytopenia requiring platelet transfusion was less of a problem than previously thought," said Dr Bruce Spiess, co-chair of the company's Scientific Advisory Board and Virginia Commonwealth University professor of Anaesthesiology and Emergency Medicine. "Of the nine patients studied, three received platelet transfusions, two received platelet transfusions after Oxycyte, and one patient received platelets even before getting Oxycyte. The response to brain trauma and/or Oxycyte was highly variable with respect to platelet number. Some patients actually increased their platelet numbers. No bleeding was found to correlate with any decrease in platelet numbers. We think that the information being submitted makes a compelling case for moving ahead with the next TBI clinical trials."

The dose escalation studies will focus on finding the lowest dose of Oxycyte that reduces thrombocytopenia and still provides clinical benefit in traumatic brain injury. Dose levels of Oxycyte would start at 0.5ml/kg body weight (15 patients) and escalate in steps to 1.0 ml, 2.0 ml, and 3.0 ml for subsequent patient cohorts. Patients will be assigned a dose level in the order of their entry into the study, with patients enrolled at each increasing dose level. Up to 100 patients may be enrolled.

Chris J Stern, DBA, company chairman and CEO, says the revised protocol offers a path to faster results than the previous plan for a larger, double-blind study. "Since data can be analyzed after every phase of dose escalation, we'll have data available at very early stages. That is a real advantage over a large, double-blinded trial where data is only available at the end of the trial. Data is the prerequisite as we look for business and license partners. I am confident that we will have solid TBI trial data in 2009. And since part of the trial can be financed with the funds the University of Miami received from the Department of Defense, we should have a relatively inexpensive and very fast trial model," said Stern.

Depending on the timing of the FDA review processes, patient enrolment could begin in the first quarter of 2009. After this submission the agency has 30 days to decide whether to accept the proposed dose escalation protocol for review. Timing of the start of the clinical trial would depend on the nature of the comments during the agency's review of this submission.

The company expects the dose escalation study also to be the foundation for further indications such as sickle-cell crisis pain, cardiac, or spinal cord injury.

"In parallel, we have now begun the pre-clinical safety and toxicity studies for our first wound care indication for Oxycyte and we were able to start these studies a little earlier than expected," said Stern. "These topical treatments may be able to qualify for registration as medical devices, which would have a much shorter and simpler review process than drugs. I believe that these topical applications could lead to partnership and licensing income which we can invest in further development of the clinical indications."

Oxygen Biotherapeutics is dedicated to commercializing innovative pharmaceuticals and medical devices in the field of oxygen therapeutics and continuous substrate monitoring.