Healthcare Industry News: BD
News Release - March 6, 2008
Office of Naval Research Provides $3.5 Million in New Grants for Clinical Research Involving Synthetic Blood International's Oxycyte(R)COSTA MESA, Calif.--(HSMN NewsFeed)--Synthetic Blood International, Inc. (OTCBB:SYBD ) announced today that Virginia Commonwealth University Reanimation Engineering Shock Center (VCURES) has received four separate research grants from the Office of Naval Research (ONR) totaling $3,517,696. These four grants will support pre-clinical research studies involving Oxycyte®, a product of Synthetic Blood International. Oxycyte is the company’s perfluorocarbon (PFC) therapeutic oxygen carrier and blood substitute.
Bruce Spiess, M.D., Virginia Commonwealth University Professor of Anesthesiology and Emergency Medicine, Director of Research (Anesthesiology) and Director of VCURES said, “These grants will allow us to expand upon the previous studies which showed that early intervention with Oxycyte can prevent the destruction of nerve cells, brain tissue in a number of conditions including decompression illness and gas embolism.”
Approximately $1.2 million (over 3 years) will be utilized in ongoing studies of perfluorocarbon emulsions in the treatment of severe decompression sickness (DCS). DCS occurs in dive accidents, mine workers, high altitude and space flight, and is a potential complication of rescue from a disabled submarine (DISSUB). This grant supports on-going work at VCURES which has demonstrated Oxycyte’s significantly improved oxygen delivery to tissues and increased removal of nitrogen from the body in past experiments.
A $1.6 million grant (over 3 years) was made for support of research into Oxycyte’s ability to treat/prevent organ damage from arterial gas embolism (AGE). AGE is a potential result of DCS but also occurs during a number of surgical procedures including cardiac surgery, orthopedic-joint replacement, gynecologic surgery, and neurosurgery.
A $300,000 dollar grant (over two years) was made to sponsor a post-doctoral candidate to work in the microcirculation laboratories of VCURES supporting research in AGE, DCS, as well as other work in traumatic brain injury (TBI). This support will extend the effectiveness of other PhD personnel already involved in basic science investigations of critical oxygen delivery to tissues with and without the presence of Oxycyte.
The fourth grant was for approximately $300,000 to develop pilot studies into the effectiveness of Oxycyte in treating traumatic brain injury secondary to a blast. Blast injury is the largest single cause of mortality and long term morbidity for coalition troops stationed in Iraq and Afghanistan. The VCURES work in blast injury will carefully dovetail with other Oxycyte research in TBI. Prior work from VCURES has shown PFC to be effective in treating TBI from isolated blunt closed head injury and blast, as a mechanism for brain injury, may well have similarities as well as differences from isolated blunt contusive brain injury. The goals of the researchers are to not only investigate the basic science but also to rapidly transition any medical advantages to the troops as soon as possible. Data from all four of these grants will provide basic science backing to other potential applications for this unique oxygen therapeutic in acute critical illness. These four grants together demonstrate the commitment that the DOD and ONR has to finding solutions to combat casualty care as well as interest in the third generation PFC – Oxycyte.
“These grants to VCURES following the announcement last week of a $1.9 million grant from the Department of Defense to further study Oxycyte in treating traumatic brain injury are a strong indication that the military sees the potential benefits of Oxycyte in preventing or arresting brain damage,” said Robert Larsen, president and CEO of Synthetic Blood, International. “We are hopeful that these additional funds will lead to results that can speed us on the road to approval by the FDA.”
Said Dr. Spiess, who also is the co-chairman of Synthetic Blood’s Scientific Advisory Board, “We’re eager to put these funds to work to help lead to treatments that improve patient outcomes in these critical areas.”
Synthetic Blood International plans to begin a Phase IIb trial of Oxycyte in 200 TBI patients in the second quarter of this year.
About Synthetic Blood International
Synthetic Blood International is dedicated to commercializing innovative pharmaceuticals and medical devices in the field of oxygen therapeutics and continuous substrate monitoring. The Company has under development an oxygen therapeutic/blood substitute and a 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.sybd.com.
Caution Regarding Forward-Looking Statements
This news release contains certain forward-looking statements by Synthetic Blood International, Inc. that involve risks and uncertainties and reflect the company's judgment as of the date of this release. These statements include commencement of clinical trials, planned patient enrollment, and other research studies involving Oxycyte. Actual events or results may differ from Synthetic Blood International, Inc.'s expectations. There can be no assurance that the planned research studies and clinical trials will be conducted in the expected time frame or that any such studies and trials will be successful. Additional information concerning these and other risk factors affecting Synthetic Blood International, Inc.'s business can be found in the company's public periodic filings with the Securities and Exchange Commission, which are available via www.SYBD.com. Synthetic Blood International, 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.
Source: Synthetic Blood International
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