MORRISVILLE, N.C., Feb. 1, 2012 (GLOBE NEWSWIRE) -- Oxygen Biotherapeutics, Inc. (Nasdaq:OXBT) and privately held Aurum Biosciences Ltd. of Glasgow, Scotland, today jointly announced they have signed a long-term agreement to develop a better tool for defining the extent of injury in acute ischemic stroke and for treating this emergency in the important early hours after the attack. At the center of both efforts is Oxygen Biotherapeutics' proprietary, perfluorocarbon-based Oxycyte emulsion, which is known for delivering large amounts of oxygen to the brain. The key to the diagnostic work lies in Aurum's proprietary GOLD (Glasgow Oxygen Level-Dependent) Magnetic Resonance Imaging (MRI) technology, which has already shown great promise in mapping potentially salvageable tissue in the brain after stroke in the brain.
An ischemic stroke occurs when a blood vessel that carries oxygen and nutrients to a particular region of the brain is blocked by a clot. Once this event happens, the affected part of the brain cannot get the oxygen it needs and, therefore, begins to die. The objective of all stroke treatments is to salvage as much of the surrounding ischemic penumbra as possible, the region of potentially viable tissue with critically low blood flow and oxygen supply. This could result in improved functional capacity in the stroke patient.
Oxygen Biotherapeutics will supply Oxycyte and provide scientific expertise to Aurum for the preclinical studies that have already begun and for the clinical trials in stroke that are expected to follow. Funding of around £240K for the project was recently secured in Scotland.
Per the agreement, Aurum will conduct a series of in vitro and in vivo studies to explore whether Oxycyte administered while the patient is receiving oxygen therapy allows for optimization of MRI scans and improved outcomes. Specific objectives aimed at establishing the therapeutic potential of Oxycyte include determining whether the oxygen carrier:
- modulates mechanisms of oxidative stress, mitochondrial damage, and apoptotic cell death, in neuronal cells;
- increases tissue survival in the stroke penumbra as demonstrated by MRI and functional outcomes;
- impacts stroke-induced brain injury progression and final infarct size;
- can be used in conjunction with existing thrombolytic (e.g., TPA) strategies, extends the therapeutic time window, or is contraindicated;
- is compatible with current thrombolytic (rt-PA) therapy.
"This research is significant because we continue to need better treatments for stroke and to better understand which tools can be combined to assess what is occurring in the body when therapies are delivered," said Gerry McGettigan, Chief Executive Officer of Aurum. "It is our intent that this collaboration will lead to a commercial agreement to explore the value of using Oxycyte and GOLD MRI to image damaged tissue, and both diagnose and treat acute ischemic stroke."
Added Dr. Timothy Bradshaw, Executive Vice President of Drug Development at Oxygen Biotherapeutics, "Aurum brings significant expertise in stroke imaging and I look forward to working with them to determine if the combination of their GOLD technology and our Oxycyte emulsion will improve outcomes for stroke patients. Moreover, this work is personal for me because I watched my father suffer a stroke during a family dinner. When his stroke occurred, I vividly recalled visiting my grandfather who was in a nursing home after having a severe stroke. I came to Oxygen Biotherapeutics because I believe in the potential of using PFC emulsions to treat ischemic emergencies such as traumatic brain injury and stroke. If our collaboration is successful, it could be the most important development in this therapeutic area since the advent of thrombolytics."
About Oxycyte and GOLD MRI
Oxycyte is a perfluorocarbon-based emulsion designed to enhance oxygen delivery to ischemic tissues that have been damaged by disease or trauma. Oxycyte molecules are approximately 50 times smaller than red blood cells allowing them to flow into small capillaries and around damaged tissue.This feature and other physical properties of Oxycyte enable it to gather oxygen from the lungs and transport the oxygen through the body releasing it along the way. Oxygen Biotherapeutics uses a proprietary process of perfluorocarbon production and emulsification to produce Oxycyte. Research indicates Oxycyte forms a stable emulsion, is metabolically inert, is efficiently eliminated from organs, has an appreciable residence time in blood, and has 50 times higher oxygen solubility and diffusibility than hemoglobin in red blood cells.
The GOLD technology is based on two fundamental principles:1) the magnetic properties of oxygen, and 2) the change in metabolism of cells when oxygen is turned on or off. Two complimentary patented MRI techniques have been developed to exploit these properties. The first GOLD technique produces images based on the magnetic properties associated with differential oxygenation of brain tissue, as a result of the clot that causes the stroke preventing blood carrying oxygen to the brain. The second technique enables us to "see" certain chemicals that are produced when oxygen is turned on or off due to the metabolic changes that this causes. Together, this information tells us whether compromised but salvageable tissue in the brain still exists, and therefore, whether saving this tissue may help improve the patient's condition. Based on Aurum's published data with GOLD, it is believed that by administering Oxycyte to the patient prior to the MRI scan, highly detailed brain maps can be generated automatically in times not achieved before, facilitating decisions regarding treatment and improving the opportunity to limit morbidity and mortality. This information is not currently available to clinicians. Thus, GOLD is unique in its property of not only detecting penumbra but also supporting the survival of this compromised but salvageable tissue following stroke.
U.S. and U.K. Stroke Statistics
According to the American Stroke Association, approximately 795,000 Americans each year suffer a new or recurrent stroke. That means, on average, a stroke occurs every 40 seconds. Stroke kills more than 137,000 people a year in the United States alone and is the third leading cause of death behind diseases of the heart and cancer. On average, every 4 minutes someone dies of stroke. About 40 percent of stroke deaths occur in males, and 60 percent in females. According to The Stroke Association, an estimated 150,000 people have a stroke in the U.K each year, accounting for around 53,000 deaths annually. Stroke is the third most common cause of death in England and Wales, after heart disease and cancer. Stroke accounts for 9 percent of all deaths in men and 13 percent of deaths in women in the U.K.
About Aurum Biosciences, Ltd.
Aurum Biosciences is dedicated to protecting lives through the use of its proprietary imaging technology and novel approach to therapy in areas such as stroke, cardiovascular disease, oncology and epilepsy. The technology behind Aurum's products has come from researchers at the Southern General Hospital in Glasgow and The University of Glasgow, both leaders in the fields of neurological, cardiovascular and oncological disease research.
About Oxygen Biotherapeutics, Inc.
Headquartered in Morrisville, NC, Oxygen Biotherapeutics, Inc. is developing medical and cosmetic products that efficiently deliver oxygen to tissues in the body. The company has developed a proprietary perfluorocarbon (PFC) therapeutic oxygen carrier product that is being formulated for both intravenous and topical delivery. Currently, Oxygen Biotherapeutics is focused on perfluorocarbon-based oxygen carriers for use in traumatic brain injury, decompression sickness, personal care, and topical wound healing, and supports or collaborates with others researching the use of Oxycyte to treat other indications, including stroke. The company has commercialized its DERMACYTE® line of oxygen-rich skin care products. More information is available at www.oxybiomed.com, or www.DermacyteUS.com.
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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. These statements include the Company's ability to execute the research and development agreement with Aurum Biosciences Ltd. 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 report on Form 10-Q filed on December 15, 2011, and the Form 10-K filed on July 15, 2011. 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.