AG013 for Oral Mucositis

ActoGeniX’s AG013 is an ActoBiotic™ delivering Trefoil Factor peptide (TFF) for the treatment of oral mucositis. TFF’s are a class of peptides that play an important role as healing factors in the restoration of damaged mucosal lining along the gastrointestinal tract.

Mucositis is the painful inflammation and ulceration of the mucous membranes lining the digestive tract, usually as an adverse event of chemo- and/or radiotherapy treatment for cancer. Oral and gastrointestinal mucositis can affect up to 100% of patients undergoing high-dose chemotherapy and hematopoietic stem cell transplantation, 80% of patients with malignancies of the head and neck region receiving radiotherapy and a significant part of patients receiving chemotherapy. Oral mucositis increases the complexity in the cancer treatment and hence affects mortality and morbidity and contributes to rising healthcare costs. Current treatments are  aimed at maintaining oral hygiene, treating pain and reducing infection risk.

AG013 has shown very promising efficacy results in animal models of both intestinal as well as oral mucositis. ActoGeniX is developing this ActoBiotic™ for oral mucositis and plans to start a Phase 1 clinical study with AG013 in early 2009.