Access Pharmaceuticals Announces Positive Data From MuGard Phase 4 Clinical Trial In Oral Mucositis At MASCC/ISOO 2012 Symposium
DALLAS and NEW YORK, June 28, 2012 /PRNewswire/ — 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.”
About the Study: Access initiated the Phase 4 clinical trial of MuGard in 2010 with first sites opened and subjects enrolled in the first quarter of 2011. The rigorously designed trial is a prospective, randomized, multi-center, double-blind, placebo-controlled study to evaluate the efficacy of MuGard in controlling symptoms caused by oral mucositis in subjects receiving chemoradiation therapy for the treatment of cancers of the head and neck. The protocol, whose primary contributor was Stephen T. Sonis, DMD, DMSc, a thought leader in oral mucositis, is designed to evaluate MuGard with a rigor that is typically associated with drugs or biological. Access believes this trial design is the first to be used to evaluate a device for an oral mucositis indication and distinguishes Access and MuGard from competing companies and products. In addition to the primary study endpoints which assess MuGard’s efficacy, the protocol provides for the collection of a range of other endpoints including quality of life and pharmacoeconomic outcomes. Details on the MuGard Phase 4 clinical trial are available at the ClinicalTrials.gov website (http://clinicaltrials.gov/ct2/show/NCT01283906).
About Oral Mucositis: Oral mucositis (“OM”) is a debilitating side effect of some radiation and chemotherapy cancer treatments, characterized by sores and ulcers in the mouth and throat that make swallowing and continued cancer therapy difficult or impossible. It is estimated that 97% of patients receiving radiation for head and neck cancer, 70% of patients receiving stem cell transplantation and up to 40% of patients receiving conventional chemotherapy develop oral mucositis. The NIH estimates that there are 400,000 patients diagnosed with OM in the US annually, but OM is often under-diagnosed and the population at risk is significantly higher. Oral mucositis can lead to pain and the need for strong pain medication, difficulty or the inability to talk, swallow, eat and drink, weight loss, infection, and in the most severe instances the interruption or stoppage of cancer treatment.
About MASCC: 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. 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. For more information, please visit www.MuGard.com.
About Access: Access Pharmaceuticals, Inc. is a biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access’ products include MuGard(TM) (www.MuGard.com), which has received FDA marketing clearance for the management of patients with mucositis. For additional information on Access Pharmaceuticals, please visit our website at www.accesspharma.com.
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: our cash burn rate, clinical trial plans and timelines and clinical results for MuGard and other product candidates, our ability to achieve clinical and commercial success and our ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited to 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.
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