Oral Mucositis
Oral mucositis (OM) comprises (painful) inflammation, necrosis and ulceration of the oral mucosa, and is among the most frequently reported adverse events associated with cancer treatment. It is estimated that, in the United States alone, OM affects nearly 0.5 million individuals each year.
The cardinal symptoms of OM include debilitating pain and ulceration, leading to speaking and eating difficulties. The ulcers can reach a diameter of 4 cm, and importantly, OM adversely effects a patient's ability to sustain anti-cancer therapy. In fact, nearly half of all chemotherapy patients develop such severe mucositis that their anti-cancer treatment needs to be tempered.
Etiology
The oral cavity is lined with rapidly dividing epithelial cells, which present an unintended target for anti-cancer treatment. OM results from injury to these cells, as a consequence of chemo- and/or radiotherapy targeting rapidly dividing cancer cells.
Cell death in the epithelial layer leads to subsequent thinning of the mucosal lining, and the patient’s mouth becomes red, inflamed and eventually ulcerated. Patients usually start experiencing symptoms shortly after the onset of the anti-cancer treatment.
Standard Care
Treatment of OM is symptomatic, and mainly focused on oral hygiene.
Saltwater, chlorhexidine or analgesic mouthwash can temporarily alleviate some of the symptoms. Dietary changes have to be considered, and in some cases, even non-oral dietary supplementation.
Several biological drugs exist for the treatment of OM, including recombinant epithelial growth factors. When standard care is insufficient, these more experimental therapies can be considered, albeit only in selected cases.
ActoGeniX’s Solution
ActoGeniX is developing AG013 for the local delivery of epithelial healing factors into the oral cavity. AG013 has successfully completed advanced preclinical development, demonstrating highly promising efficacy and tolerability.
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.