Morrisville – Oxygen Biotherapeutics, Inc. (NASDAQ and SIX Swiss Exchange: OXBT) announced today that enrollment for the company’s first dermatological study will begin later this month at St. John’s Medical College Hospital in Bangalore, India. The company received formal approval from the hospital’s Ethics Review Board in December. This study is the first of a series of trials scheduled for 2012 to explore the efficacy of Dermacyte to treat a variety of dermatological conditions, such as allergic contact dermatitis, psoriasis and acne.
The trial is a randomized, double-blind, placebo-controlled study that will include approximately 30 healthy male or female volunteers aged 18-65 years. The objectives of this study are to assess Dermacyte’s ability to reduce the itch (pruritus) and the accompanying swelling and redness that occurs in histamine-mediated allergic skin reactions. The impact of the cosmetic cream on these two phenomena will be monitored over time and the effects will be compared to those of a placebo control. Efficacy of Dermacyte for treating pruritus will be assessed by a reduction of acute itch as reported by each subject using a Visual Analogue Scale, a widely accepted instrument used to evaluate itch in clinical studies; and reductions in both swelling and redness at the site.
Stude expected to be completed in late spring of 2012
The study will be conducted under the direction of the clinical research organization, Max Neeman International, and is expected to be completed in late spring of 2012. The Principal Investigator for the study is Dr. Madhukara J. “Over the last couple of years we have gathered a significant amount of evidence that suggests Dermacyte is capable of, not only reducing the intensity of certain types of pruritus, but also providing relief for a diverse range of skin disorders,” said Timothy Bradshaw, Ph.D., Executive Vice President of Drug Development at Oxygen Biotherapeutics. “This initial study will enable us to assess the ability of Dermacyte to mitigate the histaminic pathways implicated in a variety of allergic dermatoses, and it will provide the data needed to support additional investigations into related skin conditions.” (Oxygen/mc/ps)
Itch is one of the most common skin complaints that doctors receive from patients. Although there are several causes for itch, the release of histamine is often the underlying mechanism. According to the results of a cross-sectional study reported by Emory University researchers in June 2011 in the Archives of Dermatology, individuals with chronic pruritus have a similar reduction in quality of life as do individuals with chronic pain. During the allergic and inflammatory reactions underlying these diseases, histamine is released following sensitization and degranulation of the mast cells. The subsequent itching invariably leads to scratching that can cause trauma to the skin, further damaging the epidermal barrier and its function, and potentially facilitating the introduction of microbes that often lead to secondary infections. This itching is a major factor in the decreased quality of life experience by many sufferers of allergic skin conditions.
A variety of prescription and non-prescription medications are available to treat the pruritic symptoms of diseases, including antihistamines, hydrocortisone and other steroidal creams, and non-steroidal topical medications. However, many patients still suffer from their symptoms and are frequently plagued by the side effects of these medications resulting in a need for better, effective treatments.
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 called Oxycyte® that is being formulated for both intravenous and topical delivery. The company has commercialized its Dermacyte® line of oxygen-rich skin care products. In addition, the company is focused on PFC-based oxygen carriers for use in traumatic brain injury, decompression sickness, and topical wound healing. See www.oxybiomed.com, or www.DermacyteUS.com for more information.
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 the Oxycyte and Dermacyte product lines and the timing of the introduction of those new products. 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.