Biotherapeutics for Diseases of the Oral Cavity
We have entered into a worldwide Exclusive Channel Collaboration Agreement with Intrexon and Intrexon Actobiotics NV, a wholly owned subsidiary of Intrexon, pursuant to which we obtained certain exclusive rights to AG013. We intend to develop AG013 as a potential treatment of oral mucositis, or OM.
In a phase 1B clinical trial in 25 cancer patients with OM, AG013 was safe and well tolerated. Data published in the journal Cancer showed a 35% reduction of the duration of ulcerative OM in the AG013-treated patients versus the placebo-treated patients. Furthermore, close to 30% of the patients treated with AG013 were full responders while all placebo-treated patients developed ulcerative OM. Additionally, in a phase 1 pharmacokinetic (PK) study in 10 healthy volunteers, AG013 bacteria adhered to the buccal mucosa and actively secreted protein locally, resulting in homogeneous exposure to the entire mucosal surface up to 24 hours after administration of a rinse. AG013 has been granted Orphan Drug status in the European Union and we believe it may be eligible for Biologic License Application exclusivity as well as Fast Track designation with the United States Food and Drug Administration. We are undertaking further studies on oral mucositis at this time before determining to proceed with a phase 2 clinical trial.