Access provides update on new formulation of anti-inflammatory drug amlexanox

Access Pharmaceuticals, Inc.Apr 8 2014

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).