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Access Pharmaceuticals(OTCBB: ACCP)2600 Stemmons Freeway, Suite 176Dallas, TX 75207-2107Tel: (214) 905-5100Fax: (214) 905-5101
MuGard’s Effective Treatment of Mucositis
Public Relations Contact:ProActive Capital Group
50 Broad Street, Suite 1437New York, NY 10004
USAEMAIL: [email protected]
PHONE: (646) 315-7070 FAX: (646) 315-7080
Presentation by:Tom Allinder
Director, Investor Relations 2.0 for ProActive Capital
Mucositis is the painful inflammation and ulceration of the mucous membranes lining the digestive tract, usually as an adverse effect of chemotherapy and radiotherapy treatment for cancer…
MuGard is a an oral rinse which provides a protective coating to the mucus membranes inside the mouth and digestive tract…
In a comparison of patients undergoing standard care with patients using MuGard, the incidence and severity of mucositis was significantly lower for the MuGard group.
MuGard has received marketing allowance in the United States under a 510(k) from the Food and Drug Administration.
MuGard’s Effective Treatment of Mucositis
MuGard™ is formulated to provide a long-lasting yet unobtrusive protective coating of the oral membranes.
Access Pharma conducted a 56-patient multi-center, randomized, double-blind clinical study in patients undergoing radiation therapy for head and neck cancer
Subjects treated with the MuGard™ Oral Rinse had less severe mucositis when compared to 44 patients who received no specific therapy for the prevention of mucositis (Sonis et al, Cancer, 2000, 89: 2103).
The beneficial effects of MuGard™ Oral Rinse were further confirmed when they were compared to another previously published set of 18 historical controls (Epstein et al, Cancer, 2000, 89: 2258).
MuGard’s Effective Treatment of Mucositis
Access Pharma concluded that MuGard™ Oral Rinse shows substantial promise for reducing the severity of radiation-induced mucositis.
MuGard’s Effective Treatment of Mucositis
Mucositis and infections in the mouth remain major complications…
These complications continue despite the usual oral care provided for patients with cancer such as frequent mouth cleansing, rinsing with buffered saline and fluoride solutions, and administration of topical and systemic antimicrobial agents.
MuGard’s Effective Treatment of Mucositis
Key Term: Oral Mucositis Assessment Scale (OMAS)
OMAS is a scale developed in 1999.
The OMAS provides an objective assessment of oral mucositis based on assessment of the appearance and extent of redness and ulceration in various areas of the mouth.
OMAS is computed as the sum of all the individual erythema and ulceration scores, divided by the number of anatomical sites graded
MuGard’s Effective Treatment of Mucositis
Clinical Results of patients treated with amlexanox rinse vs MuGard:
MuGard’s Effective Treatment of Mucositis
“Standard Care” vs MuGard
MuGard’s Effective Treatment of Mucositis
Same Testing (“standard care”), different center (Annova)
MuGard’s Effective Treatment of Mucositis
When analyzed for mucositis severity (histogram, below), only 7% of patients never exceeded an OMAS score of 0.5 in the control groups, compared with 42% in the MuGard™ group (p = .0001).
MuGard’s Effective Treatment of Mucositis
MuGard’s Effective Treatment of Mucositis Conclusions
The anti-allergic, anti-inflammatory drug amlexanox, appears to be ineffective in either preventing, reducing the severity, or accelerating the healing of mucositis.
Recognizing the limitations of a retrospective analysis of historical databases, it appears that significant patient benefit is achieved when patients utilize MuGard™.
Compared with patients on standard care, patients using MuGard™ had delayed onset of mucositis and reduced severity, as assessed by the OMAS scoring system.
Of particular note was that 43% of patients on MuGard™experienced no mucositis (OMAS score never exceeded 0.5) compared with only 7% in the control group.
These results indicate that MuGard™ could be highly effective in the prevention and treatment of mucositis.
Public Relations Contact:ProActive Capital Group
50 Broad Street, Suite 1437New York, NY 10004
USAEMAIL: [email protected]
PHONE: (646) 315-7070 FAX: (646) 315-7080
For More Information on MuGard and Access Pharmaceuticals other Products please see:
http://www.accesspharma.com
