MuGard Data From UK Study Shows Prevention Of Oral Mucositis In Head And Neck Cancer Patients

Main Category: Cancer / Oncology
Also Included In: Pharma Industry / Biotech Industry
Article Date: 24 Jul 2009 - 2:00 PDT

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ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP), announced that its European partner, SpePharm, is collecting data from a post approval study of MuGard in head and neck cancer patients undergoing radiation treatment in the UK showing prevention of oral mucositis. In a multi-center study expected to enroll a total of 280 patients, patients are provided with seven weeks of MuGard therapy, and begin using MuGard one week prior to radiation treatment and then throughout the subsequent six weeks of planned therapy. The first 140 patients being treated in this assessment study have been enrolled and treated, and as of the time of the update, none of these patients have experienced any oral mucositis.

"The initial feedback from SpePharm on their experience in the UK, with the first 140 patients in the assessment study, exceeds our most positive expectations," stated Jeffrey B. Davis, Access' President & CEO. "Normally, roughly 100% of patients undergoing radiation treatment for head and neck cancer experience some level of oral mucositis. This condition varies from a low level of discomfort and pain, up to Grades 3 and 4 which are debilitating to the point of patients discontinuing therapy. To see a result where all or substantially all of the patients using MuGard, and using it prophylactically, are not getting oral mucositis is extremely important with respect to treatment regimens. We believe the final data set will show that MuGard should be used prophylactically with all radiation or chemotherapy regimens that have the potential to lead to oral mucositis, greatly expanding the target market."

MuGard is a novel, ready-to-use mucoadhesive oral wound rinse for the management of oral mucositis, a debilitating side effect of many anticancer treatments. Up to 40% of all patients receiving chemotherapy and/or 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, used prophylactically for patients undergoing chemotherapy and radiation therapy, is estimated to be in excess of $5 billion world-wide.

MuGard forms a protective coating over the oral mucosa when swirled gently around the mouth. In a comparison of cancer patients receiving standard mucositis care with those patients receiving MuGard, the incidence and severity of mucositis was significantly lower in the MuGard treated group using a validated scale for the assessment of oral mucositis.

About Access:

Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes propriety products for the treatment and supportive care of cancer patients. Access' products include ProLindac(TM), currently in Phase 2 clinical testing of patients with ovarian cancer, and MuGard(TM) for the management of patients with mucositis. The company also has other advanced drug delivery technologies including Cobalamin(TM)-mediated targeted delivery and oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism; Angiolix(R), a humanized monoclonal antibody which acts as an anti-angiogenesis factor and is targeted to breast cancer; and Thiarabine, a new generation nucleoside analog which has demonstrated both pre-clinical and clinical activity in certain cancers.

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: clinical trial plans and timelines and clinical results for ProLindac and product candidates acquired in the MacroChem transaction, our ability to execute licensing agreements in the future, Access' plans to continue and initiate clinical trials, the value of its products in the market (including MuGard and the size of the overall market for mucositis products), its ability to achieve clinical and commercial success and its 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.

Source: Access Pharmaceuticals, Inc

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