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MuGard Provides Significant Improvement or Stabilization of Oral Mucositis in Over 75% of Patients in European Clinical Experience
Date:10/11/2010

DALLAS and NEW YORK, Oct. 11 /PRNewswire-FirstCall/ -- Access Pharmaceuticals, Inc. (OTC Bulletin Board: ACCP), a biopharmaceutical company specializing in products for cancer and supportive care, announced the highlights from a poster presentation on European clinical experience of MuGard at this year's European Society of Medical Oncology Conference in Milan, Italy.  Some of the findings reported in the ESMO presentation included:

  • MuGard provided a significant improvement and/or stabilization of oral mucositis lesions and symptoms of oral mucositis (OM) in more than 75% of cancer patients treated with radiotherapy/chemotherapy;
  • Patients reported a 52% significant reduction in oral discomfort (oral pain and swallowing ability) in patients with pre-existing lesions of OM, and reported a substantial reduction in the use of pain medication;
  • MuGard has a ready-to-use formulation that is well accepted by 86% of patients, as reported in this assessment program;
  • No MuGard-related adverse reactions have been identified in clinical practice;
  • MuGard represents a valuable therapeutic option in the treatment and prevention of OM in cancer patients undergoing radio/chemotherapy.

  • "These additional findings out of Europe are very exciting and strengthen our belief in the clinical benefits that MuGard can provide patients undergoing radiation and chemotherapy," said Jeffrey Davis, CEO of Access Pharmaceuticals.  He continued, "This data confirms the competitive advantages of MuGard over the current treatment options on the market and we will use this data to educate patients, clinicians and the medical industry on the superior attributes of our product."

    Earlier this year, Access presented MuGard data and clinical experience at the MASCC Conference (Multinational Association of Supportive Care in Cancer). At that conference, Access presented data from a US clinical trial in patients undergoing radiation and/or chemotherapy for treatment of head and neck cancer showing that 42% of patients using MuGard preventatively never exceeded an Oral Mucositis Assessment Scale (OMAS) score of 0.5. This data underscored MuGard's potential for oral mucositis prevention. The overall comparison showed that patients treated with MuGard had significantly lower OMAS scores when compared to the three control groups. The largest benefit was observed when patients used MuGard on the first day they started cancer therapy and continued using MuGard during the entire duration of treatment. Additionally, MuGard lowered erythema (a precursor inflammatory condition to OM) scores in subjects with various oral inflammatory conditions, including patients with xerostomia, cheilitis and stomatitis. The presentation of clinical experience at the ESMO conference is the culmination of all previously announced European clinical programs.

    For additional information on MuGard, including information for clinicians, nurses and patients, please visit www.MuGard.com.

    About MuGard:MuGard is a novel, ready-to-use, easy-to-swallow, mucoadhesive oral wound liquid that provides a protective polymer coating over the mucosa.  MuGard received 510(k) marketing allowance in the US with a broad indication for treating lesions of the mouth including the management of oral mucositis. In Europe, MuGard is a class IIa medical device which has been granted CE mark certification with the following indication: prevention and management of the lesions and symptoms of oral mucositis 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 CobaCyte™-mediated targeted delivery and Cobalamin™ 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 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: CompanyContact: Investor RelationsChristine BerniDonald C. Weinberger/Diana Bittner (media)Director of Investor RelationsWolfe Axelrod Weinberger Assoc. LLCAccess Pharmaceuticals, Inc.(212) 370-4500(212) 786-6208
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    SOURCE Access Pharmaceuticals, Inc.
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