Access Pharmaceuticals Announces Publication Of MuGard Clinical Data In Cancer
Met Primary Endpoint of Statistically Significant Reduction in Mouth and
Throat Soreness Associated With Oral Mucositis; MuGard Patients Also Had
Decreased Severity of Oral Mucositis by WHO Score
NEW YORK, Feb. 18, 2014
NEW YORK, Feb. 18, 2014 /PRNewswire/ --ACCESS PHARMACEUTICALS, INC. (OTCBB:
ACCP) announced the online early publication of the final results of its
post-approval marketing study of MuGard^® in Cancer, the journal of the
American Cancer Society and one of the oldest peer-reviewed journals in
oncology. The publication, entitled "Multi-Institutional, Randomized,
Double-Blind, Placebo-Controlled Trial to Assess the Efficacy of a
Mucoadhesive Hydrogel (MuGard) in Mitigating Oral Mucositis Symptoms in
Patients Being Treated With Chemoradiation Therapy for Cancers of the Head and
Neck," is available at
http://onlinelibrary.wiley.com/doi/10.1002/cncr.28553/full. The publication
discusses data on Access' post-marketing clinical trial that evaluated the
efficacy of MuGard in controlling symptoms caused by oral mucositis in 120
patients receiving chemoradiation therapy for the treatment of cancers of the
head and neck.
MuGard was shown to be superior to the sham control saline-bicarbonate rinse
in mitigatingoral mucositis symptoms and delayingoral mucositis progression.
In the trial, MuGard met the primary endpoint, achieving a statistically
significant reduction in mouth and throat soreness associated with oral
mucositis. MuGard also achieved significance in a secondary endpoint, the
measure of mucositis severity at the end of radiation treatment using a
physician-based assessment of severity (WHO score). Additional secondary
endpoints where MuGard demonstrated superiority were reduced opioid use and
"Oral mucositis is one of the most challenging adverse side-effects we face
when treating our cancer patients," stated Dr. Ron R. Allison of Carolina
Radiation Medicine, Greenville, NC. Dr. Allison, a principal investigator in
the MuGard trial, continued "From a patient quality-of-life perspective, the
reduction in mouth-and-throat soreness and reduced dependence upon opioids are
extremely important. Patients using MuGard showed better weight maintenance,
indicative of a superior nutritional status during the intensive cancer
treatment regimen. As a physician, I was particularly impressed by the fact
that the reduction of oral mucositis severity and mouth-and-throat soreness in
the MuGard group was statistically significant."
"Oral mucositis continues to be a significant unmet medical need with horrific
symptomatic consequences. This multi-institutional study provides strong
evidence of MuGard's effectiveness in reducing pain associated with
radiation-induced injury," stated Stephen T. Sonis, DMD, DMSc, an expert on
cancer treatment complications, Clinical Professor of Oral Medicine at Harvard
and the primary author of the protocol for this trial. "Access' commitment to
demonstrate MuGard's benefit through a rigorous clinical trial process
separates MuGard from currently available rinses and sets a new standard for
evidence-based use of agents in this class."
No difference in adverse events was observed between patients receiving MuGard
and those patients receiving the saline-bicarbonate control. No patients
discontinued MuGard treatment because of an adverse event while two patients
using the sham-control ended their medication use due to nausea or vomiting.
"Access is extremely pleased with the outcome and publication of this clinical
study of MuGard, and thank the many participating clinicians, sites and
authors for the participation in this important trial," stated Jeffrey B.
Davis, President and CEO of Access Pharmaceuticals, Inc. "Raising the level of
visibility for MuGard should expand its usage, and availability, both
domestically and abroad. Access is actively seeking additional marketing
agreements in Europe, the Far East and in other un-licensed territories and
will keep all stakeholders apprised as to developments in this area."
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 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. There are
an estimated 400,000 patients diagnosed with OM in the US annually, but OM is
often under-diagnosed and the population at risk is significantly higher.
About MuGard: MuGard^® Mucoadhesive Oral Wound Rinse is indicated for the
management of oral mucositis/stomatitis (that may be caused by radiotherapy
and/or chemotherapy) and all types of oral wounds (mouth sores and injuries),
including aphthous ulcers/canker sores and traumatic ulcers, such as those
caused by oral surgery or ill-fitting dentures or braces. MuGard is available
by prescription only and is contraindicated in patients with known
hypersensitivity to any of the ingredients in the formulation. MuGard was
launched in 2010 after receiving 510(k) clearance from the U.S. Food and Drug
Administration and is marketed by AMAG Pharmaceuticals, Inc. in the United
About Access: Access Pharmaceuticals, Inc. is an emerging biopharmaceutical
company that develops and commercializes proprietary products for the
treatment and supportive care of cancer patients. Access developed MuGard and
is developing multiple follow-on products. Access 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 MuGard and Cobalamin, 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
Company and Media Contact:
Access Pharmaceuticals, Inc.
SOURCE Access Pharmaceuticals, Inc.
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