New Data: Patients treated with MuGard saw significant clinical benefit Print E-mail
By Staff and Wire Reports   
Thursday, 24 June 2010 05:27

As we told our subscribers yesterday, Access Pharmaceuticals (ACCP.OB) is presenting a scientific poster today at the Multinational Association of Supportive Care in Cancer (MASCC) Conference in Vancouver, B.C.

BioMedReports has been in touch with company officials to get further clarification about the importance and significance of the data and we expect to post a full report later today. At first glance, however, it appears that this data provides those who most often recommend the product to cancer patients ( the oncology medicine community)  with key positive findings which will help the commercial development and marketing efforts of MuGard in North America.

According to the company, 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 presentation 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 an 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.

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.

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.




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