Access Pharmaceuticals Announces Positive Top-Line Data From MuGard™ Phase IV Clinical Trial In Oral Mucositis Patients

Access Pharmaceuticals Announces Positive Top-Line Data From MuGard™ Phase IV
    Clinical Trial In Oral Mucositis Patients Presented At MASCC/ISOO 2013
                                  Symposium

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

PR Newswire

DALLAS and NEW YORK, June 27, 2013

DALLAS and NEW YORK, June 27, 2013 /PRNewswire/ -- ACCESS PHARMACEUTICALS,
INC. (OTCBB: ACCP), an emerging biopharmaceutical company, announced that Dr.
Ron R. Allison of Carolina Radiation Medicine, Greenville, NC, presented
top-line results today from a phase IV clinical trial evaluating MuGard™
Mucoadhesive Oral Wound Rinse at the MASCC/ISOO International Symposium on
Supportive Care in Cancer in Berlin, Germany. The prospective, randomized,
multi-center, double-blind, placebo-controlled study 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.

The presentation, entitled "The Multi-Institutional, Randomized, Double-Blind,
Placebo-Controlled Trial to Assess the Efficacy of MuGard in Mitigating Oral
Mucositis (OM) in Chemoradiation-Treated Head and Neck Cancer Patients"
summarized top-line data on 78 patients who were enrolled in the study for a
minimum of two weeks. The patients were randomized 1:1 to receive either
MuGard or placebo (a saline-bicarbonate rinse), with 37 evaluable MuGard
patients and 41 evaluable placebo patients summarized in this analysis.

The primary endpoint of the study was the reduction of symptoms of oral
mucositis, as determined by the area-under-the-curve (AUC) of Oral Mucositis
Daily Questionaire (OMDQ) Mouth and Throat Soreness (MTS) question 2, a
validated mucositis assessment tool. MuGard met the primary study endpoint,
with patients receiving MuGard experiencing a statistically significant
reduction versus placebo in mouth and throat soreness. In addition, fewer
patients receiving MuGard had ulcerative OM (WHO score >/= 2) at the end of
radiation therapy.

"For this head and neck cancer population, the debilitating side effect of
oral mucositis remains one of our most significant clinical challenges. The
benefits of MuGard shown in these results are critically important, both
clinically and from a patient quality-of-life perspective," stated Dr. Ron R.
Allison, a principal investigator in the MuGard trial, Carolina Radiation
Medicine, Greenville, NC. "MuGard helps patients manage their mucositis
during these tough treatment regimens."

"Oral mucositis is a significant medical need for this population and these
study results provide strong evidence of MuGard's effectiveness in managing
the mouth and throat soreness associated with it," stated expert on
cancer-treatment mucosal toxicities, Stephen T. Sonis, DMD, DMSc, Clinical
Professor of Oral Medicine at Harvard and consultant to Clinical Assistance
Programs for this trial.

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. 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.

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™ 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 States.

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, a prescription
oral rinse for the management of mucositis and is developing multiple
products, and recently licensed US commercialization rights to AMAG
Pharmaceuticals, Inc. 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 ProLindac, 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
Commission.

Company and Media Contact:

Christine Berni
Director of Investor Relations
Access Pharmaceuticals, Inc.
(212) 786-6208



SOURCE Access Pharmaceuticals, Inc.

Website: http://www.accesspharma.com
 
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