NEW YORK, April 8, 2014 /PRNewswire/ -- ACCESS
PHARMACEUTICALS, INC. (OTCBB: ACCP) provided an update on a new
formulation of the anti-inflammatory drug amlexanox, called
LexaGard™, for the treatment of inflammatory and ulcerative
conditions of the esophagus. Amlexanox is a novel anti-inflammatory
and anti-allergic agent that has been approved and used in the US,
Japan and other countries, in
numerous formulations, for the treatment of a variety of conditions
including recurrent aphthous ulceration (RAU), bronchial asthma and
allergic rhinitis. Amlexanox is known to inhibit formation and
release of histamine, TNF-alpha and leukotriene from mast cells,
basophils and neutrophils, and has strong anti-inflammatory effects
in mucosal tissue with few adverse effects. By formulating
amlexanox in its proprietary mucoadhesive polymer hydrogel delivery
system, Access has a patented and protectable formulation of this
interesting pharmaceutical active.
"Leveraging upon our success with MuGard®, Access is
actively working on a number of follow-on products that focus on
applications of our base product in other mucosal tissue, such as
the recently discussed ProctiGard™ for the treatment of radiation
proctitis, and now LexaGard™ which incorporates an active
pharmaceutical agent," stated Jeffrey B.
Davis, President and CEO of Access Pharmaceuticals, Inc.
"While Access is exploring the use of LexaGard™ in the esophagus,
in conditions such as Barrett's esophagus, amlexanox has been
gaining renewed attention recently as academic studies have shown
that it may have broad utility in a number of conditions that are
caused or exacerbated by chronic, low-level inflammation, such as
diabetes, obesity and a variety of neurological conditions. We
believe a proprietary formulation of amlexanox, in an easy to use
format, could have broad clinical applications and commercial
appeal."
LexaGard™ is a proprietary formulation of amlexanox in a
mucoadhesive hydrogel formulation designed for treatment of
conditions of the upper gastrointestinal tract including Barrett's
esophagus and esophagitis. Amlexanox has been shown to be as
effective as dexamethasone in treatment of erosive oral lichen
planus. Barrett's esophagus is a pre-cancerous condition thought to
be caused by chronic acid exposure from reflux esophagitis, and is
estimated to be present in 10% to 20% of patients with
gastroesophageal reflux disease (GERD).
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, 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:
Scott Nogi
Vice President
Access Pharmaceuticals, Inc.
(212) 786-6203
SOURCE Access Pharmaceuticals, Inc.