Oxygen Biotherapeutics (Costa Mesa, California) is hoping to have found a shorter and simpler way to get its first Oxycyte wound treatment product to market – by calling it a medical device rather than a drug.

The company reported that it has begun pre-clinical safety and toxicity studies for its first Oxycyte wound treatment indication, and Chris Stern, CEO and chairman, said the company was able to start these trials "a little earlier than expected."

Oxycyte is the company's perfluorocarbon therapeutic oxygen carrier.

Stern told Medical Device Daily that the company's topical treatments may be able to qualify for registration under medical device protocols, thus providing 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," Stern said.

In a business update letter to shareholders dated Dec. 2, Stern said the company could be generating income as early as 2009 because its topical use indications for Oxycyte are ahead of schedule. "Recently we were able to make a gel from Oxycyte that retains its superior oxygen characteristics," he wrote.

Stern also said in the letter that the first product for skin wounds could be a simple one that has several small doses of Oxycte, along with several separate bandages in the package.

Once that product is launched, Stern said, the company would be ready for a more complex all-in-one wound product including on oxygen delivery system with hydrogen peroxide.

Other products in the Oxygen Biotherapeutics pipeline that Stern mentioned in an interview with MDD include a delivery system to treat acne with Oxycyte gel. Again, he said the company probably wouldn't launch that that product until the wound treatment product is on the market, he said.

The company has planned its product pipeline, Stern said, in a way that it hopes to be getting income from its topical products next year to finance the clinical products.

"We're the only biomedical company I know of that actually has a fast track topical product line to finance the clinical," Stern said.

Oxygen Biotherapeutics also reported that it 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).

Stern said that the submission is just "another step forward" to getting a clinical product on the market.

Following the company's meeting with the FDA on Oct. 22, the agency requested more 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 Bruce Spiess, MD, co-chair of the company's scientific advisory board and a professor of anesthesiology and emergency medicine at Virginia Commonwealth University (Richmond).

"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." He said, 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."

Oxygen Biotherapeutics said the dose escalation studies would 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 ml, 2 ml, and 3 ml for subsequent patient cohorts. Patients will be assigned a dose level in the order of entry into the study, with patients enrolled at each increasing dose level, the company said. Up to 100 patients may be enrolled.

"Since data can be analyzed after every phase of dose escalation, we'll have data available at very early stages," Stern said. "That is a real advantage over a large, double-blinded trial where data is only available at the end of the trial."

Stern said that a robust amount of data is the prerequisite as the company looks for business and license partners.

"I'm 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," he added.

Depending on the timing of the FDA review processes, patient enrollment could begin in 1Q09, according to the company. 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 noted.

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