Access Pharmaceuticals, a biopharmaceutical company focused on oncology, has released interim results from its ongoing MuGard phase IV clinical trial in oral mucositis.
An interim analysis from the first 40 patients enrolled in the trial showed that patients using MuGard experienced a statistically significant reduction in mouth and throat soreness and a reduction in the use of opioid pain medication compared to patients in the control arm. The trial is continuing to enroll patients and Access anticipates presenting clinical data at a leading oncology supportive care conference this summer.
Access initiated the phase IV 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, 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.
"Access should be commended. By undertaking a study which vigorously assesses MuGard's efficacy, the company is setting a new standard for the evaluation of mucositis devices,” sad Sonis. “The study's results will provide clinicians with real data to support evidence-based decision making. Reaching statistical significance on key endpoints, even with the small interim sample size evaluated, is compelling.”
Jeffrey B. Davis, president and CEO of Access Pharmaceuticals, added, "The clinical benefit is evident in the ever increasing commercial adoption of MuGard as evidenced by increasing script volume, increasing reimbursement and inclusion in formularies of the largest pharmacy benefit managers, insurance plans, group purchasing organizations and leading cancer institutions such as Memorial Sloan Kettering Cancer Center here in New York."
Access Pharmaceuticals intends on presenting and publishing final data in peer reviewed publications in 2012.