}Potential expansion to other markets, such as dental market, oral surgery, etc.
Clinical Study
} The clinical study was conducted at 11 centers.
Patients rinsed up to 6 times a day with MuGardTM during a course of radiation therapy (with or without concomitant chemotherapy) with a planned dose of at least 60 Gy over 6-7 weeks.
Patient mucositis was evaluated 3 times a week according to the Oral Mucositis Assessment Scale (OMAS), a validated assessment scale
MuGardTM data were compared with data from two similar sets of patients receiving standard care. Statistical analysis comparing the mean maximum OMAS score of the MuGardTM group to each of the untreated groups was performed using two-sided tests at the 0.05 level of significance.
42% of patients in the MuGardTM Rinse group
did not develop significant mucositis during the 6-7
week radiation treatment cycle compared with only
9% in the historical control group
Summary
- MuGard has a US 510(k) FDA marketing allowance and European CE Mark approval
- Access has recently announced agreements with SpePharm for the EU, Milestone for the US, JCOM in Korea, and RHEI for China and other Southeast Asian countries
- "Prevention" positioning yields significant sales potential and lessens the number of competitive products
- In patients receiving radiation therapy for head and neck cancer, 42% of patients using MuGard Rinse group did not develop significant mucositis compared with only 9% in a historical control group
- Simple ready to use formulation is major competitive advantage
MuGard Entering Europe (Extensive Market)
ACCESS PHARMACEUTICALS, INC.
