AG013 for Oral Mucositis
AG013 is ActoGeniX’ lead product an ActoBiotic™ that is being developed for the prevention and attenuation of oral mucositis (OM). OM is among the most frequently reported adverse events associated with cancer treatment.
Clinically, OM results in the painful inflammation and ulceration of the membranes lining the oral cavity. It is estimated that in the United States alone, OM affects nearly 0.5 million individuals each year. OM increases the complexity of a patient’s cancer treatment, and thus contributes to increased mortality, morbidity and healthcare costs. Furthermore, current treatment options are mostly limited to maintaining oral hygiene, treating pain and reducing infection risk.
AG013 is formulated as a convenient oral rinsing solution, and is expected to combine excellent efficacy with a favorable safety profile. AG013 delivers a specific human healing factor, namely Trefoil Factor (TFF), to the mucosal tissues in the oral cavity. TFFs are a class of peptides that are involved in protection of the gastrointestinal tissues against mucosal damage, and have an important role in subsequent repair. Oral application of human TFFs has already been demonstrated to have therapeutic potential in the treatment of OM.
In May 2009, the FDA approved ActoGeniX’s IND application, allowing the Company to initiate a phase 1B clinical trial with AG013 in cancer patients at risk of developing oral mucositis. Meanwhile, ActoGeniX has started this clinical study in collaboration with several reputed oncology centers in the US. The primary aim of the study is to evaluate safety and tolerability of AG013, but it will also allow collection of initial efficacy data.