DALLAS and NEW YORK, Sept. 24, 2013 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), an emerging biopharmaceutical company, announced a poster presentation at the American Society for Radiation Oncology Meeting, September 22-25, 2013, in Atlanta, GA. The poster presentation, co-authored by Access Pharmaceuticals' Senior Vice President Research and Development, Dr. David Nowotnik, entitled, "Results from the Multi-Institutional, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy of MuGard® in Mitigating Oral Mucositis (OM) in Chemoradiation-Treated Head and Neck Cancer Patients", discusses the findings from the Company's post-marketing clinical trial that evaluated the efficacy of MuGard in controlling symptoms caused by oral mucositis in 120 patients receiving chemoradiation therapy for the treatment of cancers of the head and neck.
MuGard was shown to be superior to the sham control rinse in mitigating OM symptoms and delaying OM progression. In the trial, MuGard met the primary endpoint, achieving a statistically significant reduction in mouth and throat soreness associated with Oral Mucositis. MuGard also achieved significance in a secondary endpoint, the measurement of mucositis severity at the end of radiation treatment using a physician-based assessment of severity. Additional secondary endpoints where MuGard demonstrated superiority were reduced opioid use and weight loss.
Commenting on the findings included in the poster presentation, Nowotnik stated, "The impact of mucositis on patients is significant with particular affect on their ability to eat and maintain their weight. Due to the oral pain and discomfort of OM, patients eat less and lose weight as a result. Previous studies have shown that severe weight loss during chemoradiation therapy correlates with lower quality of life after therapy and a higher risk of mortality."
"The reduction of weight loss in the patients using MuGard is an important result of this study," stated Dr. William Wisbeck, MD of the Providence Regional Medical Center, Everett, WA. A principal investigator in the clinical trial and a coauthor on the poster, Dr. Wisbeck continued, "Average weight loss in patients using MuGard was almost 4kg less than those in the control group. This magnitude of difference can suggest MuGard will lead to better clinical outcomes."
About Oral Mucositis: Oral mucositis ("OM") is a debilitating side effect of some radiation and chemotherapy cancer treatments, characterized by sores and ulcers in the mouth and throat that make swallowing difficult or impossible. It is estimated that 97% of patients receiving radiation for head and neck cancer, 70% of patients receiving stem cell transplantation and up to 40% of patients receiving conventional chemotherapy develop oral mucositis. The NIH estimates that there are 400,000 patients diagnosed with OM in the US annually, but OM is often under-diagnosed and the population at risk is significantly higher.
About ASTRO: ASTRO is the premier radiation oncology society in the world, with more than 10,000 members who are physicians, nurses, biologist, physicists, radiation therapists, dosimetrists and other health care professionals that specialize in treating patients with radiation therapies. To learn more about ASTRO, visit www.astro.org.
About MuGard: MuGard® Mucoadhesive Oral Wound Rinse is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces. MuGard is available by prescription only and is contraindicated in patients with known hypersensitivity to any of the ingredients in the formulation. MuGard was launched in 2010 after receiving 510(k) clearance from the U.S. Food and Drug Administration and is marketed by AMAG Pharmaceuticals, Inc. in the United States.
About Access: Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access developed MuGard and is developing multiple products. Access also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism. For additional information on Access Pharmaceuticals, please visit our website at www.accesspharma.com.
This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: our cash burn rate, clinical trial plans and timelines and clinical results for MuGard and Cobalamin, our ability to achieve clinical and commercial success and our ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited to Access' need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access' Annual Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.
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