Met Primary Endpoint of Statistically Significant Reduction in Mouth and Throat Soreness Associated With Oral Mucositis; MuGard Patients Also Had Decreased Severity of Oral Mucositis by WHO Score
Dallas, TX and New York, NY, June 27, 2013
ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), an emerging biopharmaceutical company, announced that Dr. Ron R. Allison of Carolina Radiation Medicine, Greenville, NC, presented top-line results today from a phase IV clinical trial evaluating MuGard™ Mucoadhesive Oral Wound Rinse at the MASCC/ISOO International Symposium on Supportive Care in Cancer in Berlin, Germany. The prospective, randomized, multi-center, double-blind, placebo-controlled study 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.
The presentation, entitled “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” summarized top-line data on 78 patients who were enrolled in the study for a minimum of two weeks. The patients were randomized 1:1 to receive either MuGard or placebo (a saline-bicarbonate rinse), with 37 evaluable MuGard patients and 41 evaluable placebo patients summarized in this analysis.
The primary endpoint of the study was the reduction of symptoms of oral mucositis, as determined by the area-under-the-curve (AUC) of Oral Mucositis Daily Questionaire (OMDQ) Mouth and Throat Soreness (MTS) question 2, a validated mucositis assessment tool. MuGard met the primary study endpoint, with patients receiving MuGard experiencing a statistically significant reduction versus placebo in mouth and throat soreness. In addition, fewer patients receiving MuGard had ulcerative OM (WHO score ≥2) at the end of radiation therapy.
“For this head and neck cancer population, the debilitating side effect of oral mucositis remains one of our most significant clinical challenges. The benefits of MuGard shown in these results are critically important, both clinically and from a patient quality-of-life perspective,” stated Dr. Ron R. Allison, a principal investigator in the MuGard trial, Carolina Radiation Medicine, Greenville, NC. “MuGard helps patients manage their mucositis during these tough treatment regimens.”
“Oral mucositis is a significant medical need for this population and these study results provide strong evidence of MuGard’s effectiveness in managing the mouth and throat soreness associated with it,” stated expert on cancer-treatment mucosal toxicities, Stephen T. Sonis, DMD, DMSc, Clinical Professor of Oral Medicine at Harvard and consultant to Clinical Assistance Programs for this trial.
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.
MASCC, or the Multinational Association of Supportive Care in Cancer, is the leading international organization dedicated to the research and education in all aspects of supportive care for patients with cancer. It joined forces with the International Society of Oral Oncology (ISOO) in 1998, and its members represent over sixty countries. The MASCC/ISOO membership includes oncology medical, surgical, and radiology physicians, nurses, dentists, dental hygienists, pharmacists and representatives from industry and non-profit sectors. Symposia are convened annually to share the most recent research in supportive care from throughout the world.
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.
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, a prescription oral rinse for the management of mucositis and is developing multiple products, and recently licensed US commercialization rights to AMAG Pharmaceuticals, Inc. 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 ProLindac, 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.