NEW YORK, April 15, 2014 /PRNewswire/ -- ACCESS
PHARMACEUTICALS, INC. (OTCBB: ACCP), an emerging biotechnology
company, announced today that positive results from a study
conducted at Nova Southeastern
University were presented recently at the Frontiers in
Oral Medicine 2014 conference, hosted by the American
Academy of Oral Medicine, in Orlando,
Florida. The poster, entitled "Effectiveness of a
Polymer-Based Muco-Adhesive (MuGard®) in the Healing of
Oral Ulcers in Erosive Lichen Planus: A Pilot Study" reflected
results of a randomized, doubled-blinded study (1:1 randomization
into MuGard® or bicarbonate rinse arm) of 20 patients
with biopsy proven oral lichen planus. Patients in the
MuGard® arm had statistically significant improvement in
ulcerations and pain, and the changes in pain were closely related
to the health of the ulcers. There was no statistically significant
change in erythema.
"Oral lichen planus is a significant unmet medical need, that
presents similarly to oral mucositis, with inflammation, erosive
ulceration and significant pain," stated Jeffrey B. Davis, President and CEO of Access
Pharmaceuticals, Inc. "The results of this study, like others
previously announced by Access, add to the growing body of clinical
evidence of the significant benefits offered by
MuGard®to patients suffering with a variety of
conditions of the oral cavity."
Oral lichen planus ("OLP") is a chronic, dermatologic autoimmune
disease affecting mucosal tissue and skin including, but not
limited to, the oral cavity, pharynx, esophagus, nails and scalp.
The prevalence of oral lichen planus in the US is unknown, but it
is estimated to affect approximately one to two percent of the
general adult population, predominately in adults older than 40
years, although younger adults and children can be affected.
Patients with OLP are believed to have a higher risk of oral cancer
and should be monitored regularly. Typically treatment includes
systemic steroids or immunosuppressants, and there is a significant
need for additional treatment regimens.
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 received 510(k)
clearance from the U.S. Food and Drug Administration and is
marketed by AMAG Pharmaceuticals, Inc. in the United States, RHEI Pharmaceuticals in
China, and Hanmi Pharmaceuticals
in Korea. Clinical data on MuGard®, entitled
"Multi-Institutional, Randomized, Double Blind, Placebo-Controlled
Trial to Assess the Efficacy of a Mucoadhesive Hydrogel (MuGard) in
Mitigating Oral Mucositis Symptom in Patients being treated With
Chemoradiation Therapy for Cancers of the Head and Neck," was
recently published online at
http://onlinelibrary.wiley.com/doi/10.1002/cncr.28553/full.
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 including ProctiGard™. 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
Commission.
Company and Media Contact:
Christine Berni
Vice President, Corporate Development
Access Pharmaceuticals, Inc.
(212) 786-6203
SOURCE Access Pharmaceuticals, Inc.