Oxygen Biotherapeutics Reports on FDA Meeting, Next Oxycyte Clinical Trial and Development Direction
Oxygen Biotherapeutics Reports on FDA Meeting, Next Oxycyte Clinical Trial and Development Direction
October 23, 2008--COSTA MESA, Calif.--(BUSINESS WIRE)--Oxygen Biotherapeutics, Inc. (OTCBB:OXBO) today announced that it had a very fruitful and productive scientific meeting with the FDA to discuss the safety and development of Oxycyte® in Traumatic Brain Injury (TBI). Oxycyte is the Company's perfluorocarbon (PFC) therapeutic oxygen carrier.
The company has subsequently decided to expand its research plan to include a sequential dose escalation safety and efficacy study of up to 40 patients. Due to the slight redesign of the protocol and administrative processes, patient enrollment is anticipated to begin in the first quarter of 2009. The company intends to conduct the study in the U.S. with a second study planned in Canada. A possible additional study in Switzerland is under review and a decision on that will be made in the near future.
The company strongly believes that this approach will significantly facilitate demonstration of the benefit-to-risk advantage of the drug in TBI and expedite its subsequent development while significantly reducing development costs.
The primary goals of these dose escalation safety and efficacy studies are to augment the clinical program with mechanistic research and determine the optimal dose for Oxycyte to result in a better outcome for patients on the Extended Glasgow Outcome Scale (EGOS). EGOS will be a primary efficacy endpoint for clinical benefit. Both the U.S. and Canadian studies will be designed as multi-center studies focusing on finding the lowest dose that reduces thrombocytopenia and still provides clinical benefit in traumatic brain injury. Related to this, the company has decided to take advantage of a unique window of opportunity to add a human study to understand the effects of thrombocytopenia and platelets in PFCs with scientific clarity not otherwise achievable in any animal model.
"This gives us a more efficient way to advance our clinical trials. It is extremely important to bring Oxycyte another step forward because we have a level of obligation to TBI patients and their families," said company chairman and CEO Chris J. Stern, DBA. "Right now there is no medical treatment for TBI patients and mortality is 20 - 25 per cent. Additionally, of those that survive, half are unable to return to the lives they had before their injury. The procedure in the dose escalation studies is designed to find the safest dose level of our drug and to bring it to market in due course. These dose escalation studies are the foundation to move to the next step of enrolling and treating TBI patients and showing what Oxycyte can do to help them recover and lead normal, productive lives."
"In addition, I believe this will give us an opportunity to pursue an Orphan Drug approval route for Military TBI/Blast Injury, which could be extremely valuable," said Stern.
Dr. Bruce Spiess, co-chair of the company's Scientific Advisory Board and Virginia Commonwealth University Professor of Anesthesiology and Emergency Medicine, discussed the importance of the thrombocytopenia-related research. "Adding a basic research component to the clinical study to find the correlation between thrombocytopenia and platelets will be a major step in science. For over thirty years low platelet count has been observed, but not understood in terms of cause. The commitment by the company to provide in-depth science will allow for future safety and provide a basis for all other applications and potentially solve numerous unresolved problems in other drugs. The knowledge gained also could be the platform for significant income. We will be the first company to seriously and rigorously apply this science. Furthermore, the importance of all this work in terms of military blast injury in treating our troops is immense. Knowing more of the science regarding thrombocytopenia can only improve their outcomes."
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 40 patients may participate in each study. Patients - both treated and control groups - will be followed for six months after treatment.
Part of the dose escalation study will be financed through a previously-announced $1.9 million grant from the United States Department of Defense to M. Ross Bullock, M.D., Ph.D., of the University of Miami Miller School of Medicine, Department of Neurosurgery. Dr. Bullock is the principal investigator for the traumatic brain injury trial protocol with Oxycyte.
To avoid biasing the studies, investors should not expect the company to provide interim results prior to their completion or before researchers have reached a point where enough patients have been treated and followed up to provide statistically meaningful data.
"While these studies are going on, we will be aggressively working on our other priority clinical applications for Oxycyte," said Dr. Richard Kiral, company President and COO. "The next in line is topical wound treatment, where we intend to file device and drug applications soon. Sickle cell pain crisis is in an intense planning phase. We are now preparing a protocol for a Phase IIa trial for that indication in the Caribbean and intend to file it in due course," Kiral said.
About Oxygen Biotherapeutics, Inc.
Oxygen Biotherapeutics, Inc. is dedicated to commercializing innovative pharmaceuticals and medical devices in the field of oxygen therapeutics and continuous substrate monitoring. The Company has under development a perfluorocarbon therapeutic oxygen carrier and liquid ventilation product and an implantable glucose sensor. These products are based upon core technologies that include biomedical applications for PFCs and medical and industrial applications for biosensors. Each of the product candidates is designed with advantages over currently marketed products in major markets including acute respiratory distress syndrome, stroke, myocardial infarction, surgery, trauma, malignant tumors and diabetes. For further information, visit www.oxybiomed.com.
Caution Regarding Forward-Looking Statements
This news release contains certain forward-looking statements by Oxygen Biotherapeutics, Inc. that involve risks and uncertainties and reflect the company's judgment as of the date of this release. These statements include those referring to plans for the commencement of new clinical trials in Traumatic Brain Injury, hoped-for outcomes, plans to study thrombocytopenia, hopes for obtaining orphan drug designation for Military TBI/Blast Injury, plans for an Oxycyte study in Canada and Switzerland in TBI, medical device applications in topical wound care, and plans for sickle cell crisis pain trials in the Caribbean. Actual events or results may differ from Oxygen Biotherapeutics, Inc.'s expectations. There can be no assurance that the planned clinical trials will begin in the estimated time frame, that if conducted the required number of patients will be enrolled, that treatments will be successful, or that any trials will meet their endpoints. Nor can there be any assurance that regulatory agencies in Canada or any other nation will approve proposed clinical trials of Oxycyte in their respective countries or that Oxycyte or any company product will be approved for market in the United States or any other country for any indications. Additional information concerning these and other risk factors affecting Oxygen Biotherapeutics, Inc.'s business can be found in the company's public periodic filings with the Securities and Exchange Commission, which are available via www.oxybiomed.com. Oxygen Biotherapeutics, Inc. disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.