Access Pharmaceuticals Provides Update On Development Of LexaGard, A Proprietary Formulation Of Amlexanox

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.