Results from Access’ MuGard Phase 4 trial on oral mucositis

Access Pharmaceuticals, Inc.Jun 29 2012

ACCESS PHARMACEUTICALS, INC.(OTCBB: ACCP), a biopharmaceutical company developing treatments in areas of oncology and oncology supportive care, announced that Dr. Ron R. Allison of Carolina Radiation Medicine, Greenville, NC, presented results from its ongoing MuGard Phase 4 clinical trial in oral mucositis (OM) at the Multinational Association of Supportive Care in Cancer (MASCC) Conference in New York City. The presentation summarized data from 70 cancer patients undergoing chemoradiation therapy for head and neck cancer. Patients using MuGard experienced a statistically significant reduction in mouth and throat soreness, a statistically significant delay to onset of oral mucositis as measured in days or cumulative radiation, and statistically significant reductions in weight loss during therapy and in the use of opioid pain medication.

"Given the significant oral mucositis typically seen in this head and neck cancer population, the benefits of MuGard shown in the results from this trial are important both clinically and from a patient quality-of-life perspective. It's critically important that we keep patients as comfortable and nourished as possible during this tough treatment regimen, to optimize clinical outcomes," stated Dr. Ron R. Allison, a principal investigator in the MuGard trial, Carolina Radiation Medicine, Greenville, NC.  He continued, "MuGard is prescribed to patients at my institute who are not eligible to participate in the clinical trial, and we see less mucositis in those patients compared to other rinses. The MuGard benefits shown, to date, suggest broad application in patients at risk of this debilitating toxicity."

"The study results are consistent with a conclusion supporting MuGard's effectiveness in the palliation of oral mucositis. MuGard's ability to mitigate symptom onset and lessen patient dependence on narcotic analgesics will have important consequences on individuals' ability to more easily tolerate anti-cancer therapy," stated expert on cancer treatment-related mucosal toxicities, Dr. Stephen Sonis, Clinical Professor in Oral Medicine at Harvard and consultant to Clinical Assistance Programs for this trial.

Key points from the MASCC presentation include:

• Trial design and populations:  Head and neck cancer patients whose treatment plan calls for receiving up to a maximum cumulative radiation dose of 72 Gray (Gy) are randomized into the MuGard arm or a control rinse (sham) arm. Data are collected and reported for two populations: the efficacy analysis population (EFF) are patients that stayed on study treatment throughout chemoradiation treatment (approximately seven weeks), and the full analysis set (FAS) are all subjects enrolled and randomized and have at least 1 post-radiotherapy assessment. Data presented today was from the first 70 of a planned 120 patients. The patient populations in each arm were well balanced as to age, gender, ethnicity, and mean Karnofsky score (a measure of functional impairment of patients). The Company believes that the rigorous design of the trial for a medical device is unprecedented and sets a high bar for competing products in the market.
• Pain: Patients taking MuGard throughout their treatment regimen had a statistically significant reduction in pain. The pain endpoint is a measure of reduction in mouth and throat soreness (MTS) over the course of cancer therapy as measured with the oral mucositis daily questionnaire (OMDQ), a validated mucositis assessment tool. MuGard patients in the EFF population experienced a statistically significant reduction in MTS pain relative to the control rinse (p=0.041). MuGard patients in the FAS population showed a strong trend in pain reduction relative to the control rinse (p=0.110).
• Delay to Onset: This endpoint is the delay in onset of oral mucositis as measured in cumulative dose of radiation (measured in grays). MuGard patients in the EFF and FAS populations both experienced a statistically significant delay to onset of oral mucositis (p=0.020 and p=0.007, respectively). The ability to extend the onset of oral mucositis out in time during treatment is important clinically and from a quality-of-life (QOL) perspective.
• Time to First Occurrence: This endpoint is a measurement, in days, to the time of first occurrence of oral mucositis. MuGard patients in the EFF and FAS populations both experienced a statistically significant delay in time to first occurrence (p=0.022 and p=0.009, respectively). This statistically significant delay in first occurrence of OM occurred in both the EFF and FAS populations, which the company believes is both clinically important and beneficial from a QOL perspective.
• Maintenance of Weight: The study also measured changes in patient weight, in kilograms, at various periods during the study. MuGard patients in the EFF population experienced a statistically significant reduction in weight loss (p=0.036) between their start and completion of radiation treatment. Mean weight loss was 9.1 kg (~20.0 lbs) and 5.2 kg (~11.4lbs) for the control and the MuGard arms, respectively. A reduction in weight loss suggests that patients on MuGard were able to keep themselves better nourished during chemoradiation, which presumably enables them to better tolerate this rather challenging treatment regimen.

Jeffrey B. Davis, President and CEO of Access Pharmaceuticals, commented, "Access believes this MuGard data is ground breaking and unique from at least two perspectives. First, this is the first product that has ever shown a statistically significant positive clinical benefit in managing the pain symptoms and delaying the onset of oral mucositis in the very difficult to treat head and neck cancer population. Second, the rigorous design of the MuGard trial is the first of its kind in a medical device treatment option for oral mucositis, setting a new standard in this area. The clinical and quality-of-life benefits shown in this data echoes what we hear in the marketplace and that is evidenced in the increasing commercial adoption of MuGard."