DALLAS and NEW YORK, April 15 /PRNewswire-FirstCall/ -- ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP), a biopharmaceutical company specializing in products for cancer and supportive care, announced today that it is collaborating with leading expert in oral mucositis (“OM”), Stephen T. Sonis, DMD, DMSc, Chief of the Division of Oral Medicine at the Dana Farber Cancer Institute and Program Director for Supportive Cancer Care at Clinical Assistance Programs, LLC (“CAP”), to further advance ongoing marketing and reimbursement efforts for MuGard. Together with Dr. Sonis, Access Pharma will develop a program to generate additional clinical data to further support the Company’s marketing and reimbursement initiatives surrounding the U.S. commercial launch of its lead product, MuGard - a FDA-approved product for the management of oral mucositis, a debilitating side effect of many anticancer treatments. Dr. Sonis will be the primary author on a study protocol aimed at obtaining specific data that will help further broaden the indication for MuGard and support reimbursement efforts geared towards enhancing payer uptake of MuGard. Any MuGard studies will run parallel with the product’s ongoing commercialization efforts.
Dr. Sonis stated, “I am pleased that the introduction of MuGard will offer patients a new alternative to help control the painful symptoms of oral mucositis. Access’ commitment to demonstrate MuGard’s effectiveness through rigorous clinical trials will separate MuGard from other currently available oral rinses and gels and set a new standard for agents in this class. I look forward to collaborating with Access’ scientific advisory board and management.”
“Dr. Sonis is the preeminent thought leader in oral mucositis today, and we are very pleased to be collaborating with him and his team at CAP to further establish MuGard’s efficacy and utility in the treatment of OM,” said Jeffrey Davis, CEO of Access Pharmaceuticals. He continued, “Dr. Sonis has the ability to provide Access with critical insight into the conditions of OM, its impact on clinical outcomes, patient health and overall healthcare costs. We believe his counsel will be enormously valuable to us.”
Dr. Sonis, Clinical Professor of Oral Medicine at Harvard, has published extensively on the biology, clinical impact, and health and economic ramifications of mucositis and has lectured widely on the subject. He regularly collaborates with industry to facilitate the development of therapeutics for cancer supportive care.
About MuGard:
MuGard is a novel; ready-to-use mucoadhesive oral wound rinse and coating for the management of oral mucositis, a debilitating side effect of many anticancer treatments. Up to 40% of all patients receiving chemotherapy and radiotherapy develop moderate to severe mucositis, and almost all patients receiving radiotherapy for head and neck cancer and those undergoing stem cell transplantation develop mucositis. Updated clinical practice guidelines for the prevention and treatment of mucositis recommend the use of a preventive oral care regimen as part of routine supportive care along with a therapeutic oral care regimen if mucositis develops. The market for the treatment of oral mucositis is estimated to be in excess of $1 billion world-wide.
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’ products include ProLindac™, currently in Phase II clinical testing of patients with ovarian cancer, and MuGard™ for the management of patients with mucositis. The company also has other advanced drug delivery technologies including Cobalamin™-mediated targeted delivery and oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism and Thiarabine, a new generation nucleoside analog which has demonstrated both pre-clinical and clinical activity in certain cancers. 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, Thiarabine and Cobalamin and other product candidates, 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 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.
Contact: Company Contact: Investor Relations Christine Berni Donald C. Weinberger/Diana Bittner (media) Director of Investor Relations Wolfe Axelrod Weinberger Assoc. LLC Access Pharmaceuticals, Inc. (212) 370-4500 (212) 786-6208
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