NEW YORK, April 15, 2014 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), an emerging biotechnology company, announced today that positive results from a study conducted at Nova Southeastern University were presented recently at the Frontiers in Oral Medicine 2014 conference, hosted by the American Academy of Oral Medicine, in Orlando, Florida. The poster, entitled "Effectiveness of a Polymer-Based Muco-Adhesive (MuGard®) in the Healing of Oral Ulcers in Erosive Lichen Planus: A Pilot Study" reflected results of a randomized, doubled-blinded study (1:1 randomization into MuGard® or bicarbonate rinse arm) of 20 patients with biopsy proven oral lichen planus. Patients in the MuGard® arm had statistically significant improvement in ulcerations and pain, and the changes in pain were closely related to the health of the ulcers. There was no statistically significant change in erythema.
"Oral lichen planus is a significant unmet medical need, that presents similarly to oral mucositis, with inflammation, erosive ulceration and significant pain," stated Jeffrey B. Davis, President and CEO of Access Pharmaceuticals, Inc. "The results of this study, like others previously announced by Access, add to the growing body of clinical evidence of the significant benefits offered by MuGard®to patients suffering with a variety of conditions of the oral cavity."
Oral lichen planus ("OLP") is a chronic, dermatologic autoimmune disease affecting mucosal tissue and skin including, but not limited to, the oral cavity, pharynx, esophagus, nails and scalp. The prevalence of oral lichen planus in the US is unknown, but it is estimated to affect approximately one to two percent of the general adult population, predominately in adults older than 40 years, although younger adults and children can be affected. Patients with OLP are believed to have a higher risk of oral cancer and should be monitored regularly. Typically treatment includes systemic steroids or immunosuppressants, and there is a significant need for additional treatment regimens.
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 received 510(k) clearance from the U.S. Food and Drug Administration and is marketed by AMAG Pharmaceuticals, Inc. in the United States, RHEI Pharmaceuticals in China, and Hanmi Pharmaceuticals in Korea. Clinical data on MuGard®, entitled "Multi-Institutional, Randomized, Double Blind, Placebo-Controlled Trial to Assess the Efficacy of a Mucoadhesive Hydrogel (MuGard) in Mitigating Oral Mucositis Symptom in Patients being treated With Chemoradiation Therapy for Cancers of the Head and Neck," was recently published online at http://onlinelibrary.wiley.com/doi/10.1002/cncr.28553/full.
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 follow-on products including ProctiGard™. 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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