DALLAS and NEW YORK, June 24 /PRNewswire-FirstCall/ -- ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP), a biopharmaceutical company specializing in products for cancer and supportive care, is presenting a scientific poster today at the Multinational Association of Supportive Care in Cancer (MASCC) Conference in Vancouver, B.C. The poster presentation, co-authored by Dr. David Nowotnik of Access Pharmaceuticals and Dr. Caroline Dumas of SpePharm Holdings, summarizes MuGard clinical experience from cancer patients globally undergoing radiotherapy and/or chemotherapy. To date, clinical experience shows that MuGard provides significant clinical benefit and is effective in the management of oral mucositis/stomatitis as well as other conditions of the oral cavity involving erythema. Key points from the poster include:
- MuGard is indicated in Europe for the prevention and management of oral mucositis, and has been used by over 2,000 cancer patients globally. A total of 185 documented patients from various studies utilized MuGard in both prophylactic and curative settings.
- European clinical experience was collected in six centers in three countries, and included cancer patients treated with radiotherapy and/or chemotherapy; one-third of the patients presented with head and neck cancer, and most received MuGard for existing lesions.
- Clinical experience showed a greater than 50% reduction in pain and oral discomfort. In an evaluation managed by Access' China partner, RHEI Pharmaceuticals, oral discomfort or pain scores as assessed by visual analog scales were reduced significantly within days of initial MuGard treatment; the reduction in pain and oral discomfort was consistent with European clinical experience, and is correlated with a reduction in the use of pain meds.
- 42% of the patients using MuGard in a US clinical program never exceeded an Oral Mucositis Assessment Scale (OMAS) score of 0.5 versus 7% in the control groups, underscoring the potential for oral mucositis prevention; 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.
- Treatment was globally well accepted in over 85% of patients and no treatment related adverse reactions were reported.
- MuGard lowered erythema (a precursor inflammatory condition to OM) scores in subjects with various oral inflammatory conditions, including patients with xerostomia, cheilitis and stomatitis.
- Patients and healthcare professionals like MuGard's ready-to-use formulation, and Access believes it supports treatment compliance by patients.
"Access is pleased with the early clinical experience that supports the prophylactic and curative profile of MuGard and we believe it is a critical weapon in the clinician arsenal to deal with the debilitating condition of oral mucositis," stated Jeffrey B. Davis, Access' President and CEO. He continued, "We remain on track with the commercial development of MuGard in the US and we look forward to keeping the oncology community and our shareholders current with ongoing clinical experience and our overall commercialization efforts."
This MuGard clinical experience poster presentation follows the Oral Mucositis (OM) Workshop last Tuesday, which was sponsored by Access and held at the British Columbia Cancer Research Centre in Vancouver. The workshop featured leading industry experts covering various topics concerning the disease, from pathogenesis and clinical factors to prevention and management of oral mucositis.
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 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.
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 technologies based on the natural vitamin B12 uptake mechanisms 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: Investor Relations
Donald C. Weinberger/Diana Bittner (media)
Director of Investor Relations
Wolfe Axelrod Weinberger Assoc. LLC
Access Pharmaceuticals, Inc.
SOURCE Access Pharmaceuticals, Inc.