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SOURCE Access Pharmaceuticals, Inc.
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
NEW YORK, Feb. 18, 2014 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP) announced the online early publication of the final results of its post-approval marketing study of MuGard® in Cancer, the journal of the American Cancer Society and one of the oldest peer-reviewed journals in oncology. The publication, entitled "Multi-Institutional, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy of a Mucoadhesive Hydrogel (MuGard) in Mitigating Oral Mucositis Symptoms in Patients Being Treated With Chemoradiation Therapy for Cancers of the Head and Neck," is available at http://onlinelibrary.wiley.com/doi/10.1002/cncr.28553/full. The publication discusses data on Access' 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 saline-bicarbonate rinse in mitigating oral mucositis symptoms and delaying oral mucositis 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 measure of mucositis severity at the end of radiation treatment using a physician-based assessment of severity (WHO score). Additional secondary endpoints where MuGard demonstrated superiority were reduced opioid use and weight loss.
"Oral mucositis is one of the most challenging adverse side-effects we face when treating our cancer patients," stated Dr. Ron R. Allison of Carolina Radiation Medicine, Greenville, NC. Dr. Allison, a principal investigator in the MuGard trial, continued "From a patient quality-of-life perspective, the reduction in mouth-and-throat soreness and reduced dependence upon opioids are extremely important. Patients using MuGard showed better weight maintenance, indicative of a superior nutritional status during the intensive cancer treatment regimen. As a physician, I was particularly impressed by the fact that the reduction of oral mucositis severity and mouth-and-throat soreness in the MuGard group was statistically significant."
"Oral mucositis continues to be a significant unmet medical need with horrific symptomatic consequences. This multi-institutional study provides strong evidence of MuGard's effectiveness in reducing pain associated with radiation-induced injury," stated Stephen T. Sonis, DMD, DMSc, an expert on cancer treatment complications, Clinical Professor of Oral Medicine at Harvard and the primary author of the protocol for this trial. "Access' commitment to demonstrate MuGard's benefit through a rigorous clinical trial process separates MuGard from currently available rinses and sets a new standard for evidence-based use of agents in this class."
No difference in adverse events was observed between patients receiving MuGard and those patients receiving the saline-bicarbonate control. No patients discontinued MuGard treatment because of an adverse event while two patients using the sham-control ended their medication use due to nausea or vomiting.
"Access is extremely pleased with the outcome and publication of this clinical study of MuGard, and thank the many participating clinicians, sites and authors for the participation in this important trial," stated Jeffrey B. Davis, President and CEO of Access Pharmaceuticals, Inc. "Raising the level of visibility for MuGard should expand its usage, and availability, both domestically and abroad. Access is actively seeking additional marketing agreements in Europe, the Far East and in other un-licensed territories and will keep all stakeholders apprised as to developments in this area."
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. There are an estimated 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 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 follow-on 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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