Oxygen Biotherapeutics Reports Successful Completion of FDA Requested Immunocompetency Studies on Ox
Jun 18th 2013 4:51PM
Updated Jun 18th 2013 5:25PM
Oxygen Biotherapeutics Reports Successful Completion of FDA Requested Immunocompetency Studies on Oxycyte®
Results from Safety Studies to be Submitted to FDA in July
MORRISVILLE, N.C.--(BUSINESS WIRE)-- Oxygen Biotherapeutics, Inc. ("OBI") (NAS: OXBT) , is a development stage biomedical company currently focused on developing its perfluorocarbon-based intravenous oxygen carrier, Oxycyte®, as a treatment for traumatic brain injury (TBI), stroke and other conditions where critical tissues are oxygen starved. Oxycyte is currently in Phase IIb clinical trials for TBI in Israel and Switzerland; however, the FDA has requested studies to explore the safety profile of Oxycyte with respect to immunocompetency as well as transient decreases in platelet numbers. The company announced today that with the successful completion of four important preclinical studies assessing Oxycyte's potential effects on the immune system, OBI has moved several steps closer to addressing the questions posed by the FDA and demonstrating a favorable benefit to risk ratio for the product. These studies were funded as part of a $2.07 million cost reimbursement grant from the U.S. Army.
The use of any drug that lowers the body's resistance to infection must be considered carefully, especially in the long-term hospitalization setting. A recent study reported in the journal, Clinical Microbiology and Infection, found that in TBI patients, the most common infection encountered is ventilator-associated pneumonia, followed by surgical site infections, urinary tract infections, pneumonia, catheter-associated bacteremias / blood stream infections and meningitis [Kourbeti, et al., Clin. Micrbiol. Infect., 19, 359-364, 2012]. Earlier this year, OBI obtained FDA buy-in for a series of studies designed to examine Oxycyte's potential impact on immune function.
In experiments that used the Influenza virus to assess the overall health of the immune system, Oxycyte had only subtle effects on antibody production and did not adversely impact clearance of this common lung infection. Similarly, in a separate study examining the early phase response of the immune system, Oxycyte did not interfere with the efficient clearance of a Streptococcal pneumonia infection from the lung. Many TBI patients will experience as a result of being intubated one or more bouts of pneumonia; therefore, these results are important in that they provide evidence suggesting that Oxycyte does not compromise the patient's ability to fight this infection often seen in the ICU. An additional experiment requested specifically by the FDA demonstrated that Oxycyte did not interfere with the ability of macrophages to identify and engulf bacteria and, thus, should have minimal effect on that clearance mechanism, which is associated with many common bacterial infections.
A fourth study was developed to test the potential immunomodulatory effects of Oxycyte in a Listeria model of systemic bacterial infection. This gram positive bacterium is extremely pathogenic and, if not controlled quickly, can progress to sepsis under conditions of immunosuppression. In our study, the administration of Oxycyte immediately prior to an injection of Listeria directly into the circulation resulted in a marked decrease in the animal's ability to fend off this infection. It is important to note, however, that Listeria is not a bacterium commonly associated with TBI patients and was used in this study simply as a tool to assess immune function. Moreover, any blood stream infection occurring in a hospitalized patient will be treated aggressively regardless of what therapy that patient has received.
Overall, we continue to make progress in the development of Oxycyte and are pleased with the immunocompetency data collected over the last several months. We also look forward to conducting additional studies that, hopefully, will continue to support the safety of Oxycyte," said Dr. Timothy Bradshaw, Executive Vice President of Drug Development at OBI who noted that the Centers of Disease Control (CDC) estimates that 1.7 million Americans suffer from TBI each year and that, currently, there is no approved treatment on the market.
Oxycyte is an odorless, milky white emulsion consisting of a perfluorocarbon, disodium, water, egg yolk phospholipids and a few other ingredients in very small amounts. It is a sterile, non-pyrogenic emulsion consisting of submicron particles (medium diameter 200-250 nanometers) of perfluoro(t-butylcyclohexane), in an aqueous medium that is slightly hypertonic and mildly buffered to a neutral pH range. It must be formulated in an aqueous emulsion for intravenous administration. Research has shown that PFCs can dissolve and release large amounts of gases, including the blood gases oxygen and carbon dioxide without binding at high concentrations of inspired oxygen.
About Oxygen Biotherapeutics, Inc.
Oxygen Biotherapeutics, Inc. is developing medical products that efficiently deliver oxygen to tissues in the body. The company has developed a proprietary perfluorocarbon (PFC) therapeutic oxygen carrier called Oxycyte® that is currently in clinical and preclinical studies for intravenous delivery for indications such as traumatic brain injury, decompression sickness and stroke. The company is also developing PFC-based creams and gels for topical delivery to the skin for dermatologic conditions and potentially wound care. In addition, the Company has commercialized its Dermacyte® line of skin care cosmetics for the anti-aging market. Dermacyte is not out-licensed to Valor Cosmetics of Switzerland.
Caution Regarding Forward-Looking Statements
This news release contains certain forward-looking statements by the company that involve risks and uncertainties and reflect the company's judgment as of the date of this release. The forward-looking statements are subject to a number of risks and uncertainties including matters beyond the company's control that could lead to delays in new product introductions and customer acceptance of these new products, and other risks and uncertainties as described in our filings with the Securities and Exchange Commission, including in the current Form 10-Q filed on September 19, 2012, and our annual report on Form 10-K filed on July 24, 2012, as well as other filings with the SEC. The company 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.
Robert Haag, 1-866-976-IRTH (4784)
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