MORRISVILLE, N.C., May 31, 2012 (GLOBE NEWSWIRE) -- Oxygen Biotherapeutics, Inc. (Nasdaq:OXBT) announced today that data from its clinical study to determine the efficacy of Dermacyte® in relieving histamine-induced pruritus show that Dermacyte elicited a significantly larger reduction in Visual Analogue Scale scores following a standard histamine skin prick compared to placebo.
The primary objective of this study was to assess the potential for Dermacyte Concentrate skin cream to reduce the itch (pruritus) and accompanying redness and swelling that occur in histamine-mediated allergic skin reactions. Efficacy of Dermacyte for treating pruritus was assessed as reported by each subject using a Visual Analogue Scale, a validated instrument used to evaluate itch in clinical studies.
This study, previously announced in January 2012, was a randomized, double-blind, placebo-controlled study which included 30 healthy male and female volunteers aged 18-65. The clinical trial was conducted at St. John's Medical College Hospital in Bangalore, India, under the direction of the clinical research organization, Max Neeman International. Dr. Madhukara J served as the Principal Investigator. In this study, a skin prick test was used as a model for other histamine-driven skin conditions such as allergic contact dermatitis, urticaria (hives) and eczema.
According to Executive Vice President of Drug Development Timothy Bradshaw, Ph.D., "While the sample size prevented a demonstration of statistical significance, there was clearly a profound drop in itch sensation when Dermacyte was applied to the area subjected to the prick test. As encouraging was the fact that no adverse event, such as local site irritation, was reported by any subject. Consequently, we are pleased that we reconfirmed the safety profile of Dermacyte as a topical product."
Added Interim Chief Executive Officer, President and Chief Financial Officer Michael Jebsen: "Completion of this study and the encouraging results mark an important milestone for our dermatology program. We believe these data will help advance our program as we work to finalize the study design and protocol for our next dermatologic indication, which we anticipate will begin in the next couple of months."
This study was the first of a series of trials Oxygen Biotherapeutics plans to conduct to determine the utility of Dermacyte as a treatment for a variety of dermatological conditions, such as allergic contact dermatitis, psoriasis, atopic dermatitis and acne. These pruritus study results support the company's overall dermatology program and provide the data needed to support the decision to move forward with a psoriasis study in the near future.
Pruritus
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 experienced 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 creams, non-steroidal topical medications, and steroidal creams. 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.
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 oxygen-carrying 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 oxygen-rich skin care products for the anti-aging market.
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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 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.
