Access Pharmaceuticals (ACCP) Announces Interim Data From MuGard Phase 4 Clinical Trial in Oral Mucositis
4/17/2012 6:58:13 AM
DALLAS and NEW YORK, April 17, 2012 /PRNewswire/ -- ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP.OB - News), a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology and oncology supportive care, announced interim results from its ongoing MuGard Phase 4 clinical trial in oral mucositis. An interim analysis from the first forty (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 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).
"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. 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," stated Dr. Stephen Sonis.
"The interim analysis is consistent with the results that we've seen in the original MuGard trial and at least three additional clinical studies that have been completed; MuGard provides significant clinical benefit in the care of patients with, or at risk of, oral mucositis," stated Jeffrey B. Davis, President and CEO of Access Pharmaceuticals. "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 final data, and having the data published in peer reviewed publications, in 2012.
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
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.
Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access' products include MuGard™ (www.MuGard.com), which has received FDA marketing clearance for the management of patients with mucositis, ProLindac™, a second generation platinum chemotherapeutic drug and Thiarabine™, a novel nucleoside analog that has demonstrated both pre-clinical and clinical activity in certain cancers; currently in a Phase 1/2a trial in hematological malignancies at M.D. Anderson Cancer Center in Houston, Texas. The company also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism. 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 ProLindac, MuGard, Thiarabine and Cobalamin 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.
Director of Investor Relations
Contact: Investor Relations
Donald C. Weinberger/Diana Bittner (media)
Wolfe Axelrod Weinberger Assoc. LLC
Access Pharmaceuticals, Inc.
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