MORRISVILLE, N.C.--(BUSINESS WIRE)--Oxygen Biotherapeutics, Inc. (“OBI”) (NASDAQ: OXBT) announced today that recent research conducted by its partner, Aurum Biosciences (“Aurum”), Glasgow, Scotland, has shown that Oxycyte®, OBI’s proprietary perfluorocarbon-based intravenous emulsion, improves imaging of the penumbra following acute ischemic stroke in a rat model. The penumbra is the region of the brain where blood supply is inadequate to support normal brain function but sufficient to maintain tissue viability for a limited period of time following stroke. It represents potentially salvageable tissue which, if the oxygen supply can be restored, could lead to improved functional outcomes for stroke patients.
In the clinical management of stroke, it is important to accurately identify patients with potentially salvageable penumbral tissue. The development of neuroprotective agents continues to be complicated due to the absence of accurate diagnostic imaging as patients with no remaining penumbra are enrolled in clinical trials. The gold standard for identification of penumbra based on metabolism is PET; however, this technique has low resolution and involves injection of radioisotopes, making it impractical as a routine clinical tool. Aurum scientists have been working for a number of years to develop a rapid and sensitive MRI-based diagnostic technique.
Aurum’s T2* Oxygen Challenge (OC) MRI imaging technique is based on conversion of deoxyhemoglobin to oxyhemoglobin, a change made possible by Oxycyte’s ability to provide oxygen into areas otherwise inaccessible to red blood cells. The use of Oxycyte allows for greater efficiency in oxygen delivery, reducing the OC from 100% to 50% oxygen, thus avoiding potential toxicities associated with 100% oxygen inhalation. This work, conducted by researchers at the University of Glasgow Institute of Neuroscience & Psychology, was presented at the prestigious Gordon Research Conference on Brain Metabolism Energy & Blood Flow held at Colby College in Waterville, Maine on August 11-12, 2012.
The development of this improved diagnostic technique paves the way for follow-on research by Aurum scientists, in accord with a research agreement in place between Aurum Biosciences and Oxygen Biotherapeutics, to investigate the therapeutic potential of Oxycyte in the treatment of acute ischemic stroke. Planned preclinical studies will investigate the use of Oxycyte combined with normobaric hyperoxia to improve oxygen delivery to the ischemic brain tissue, limiting brain damage and extending the lifespan of potentially salvageable penumbra thereby increasing the therapeutic time window for thrombolytic therapy. The use of recombinant tissue plasminogen activator (rt-PA) thrombolytic therapy is currently the only licensed therapeutic option for ischemic stroke but few patients (<5%) present early enough to receive treatment.
Timothy Bradshaw, Ph.D., Executive Vice President of Drug Development at OBI said, “We are excited by the data coming out of our partnership with Aurum Biosciences. Based on our clinical studies in traumatic brain injury, we already know of Oxycyte’s ability to supply oxygen to badly injured tissues. Developing the product for acute ischemic stroke is a rather obvious extension of that work. While there is still much to be done, the possibility of neurologists having both a diagnostic tool and an interventional drug in the same product is going to garner the attention of the medical community.”
Added Gerry McGettigan, Chief Executive Officer of Aurum: “This is another important piece of data to add to our growing body of evidence supporting the combined use of Oxycyte and Aurum’s MRI techniques in the management of acute stroke. We look forward to completing the research and preclinical development work with our colleagues at OBI, and moving towards clinical trials at the earliest opportunity.”
Acute Ischemic Stroke
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.
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 Oxygen Biotherapeutics, Inc.
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 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.
About Aurum Biosciences
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.
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 expansion of development of Oxycyte, the timing of the introduction of new products, and the progress of our research programs, including preclinical and clinical testing. 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 reports on Form 10-Q and Form-10K. 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.
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