Regulatory Affairs

Oragenics doses first patient in phase 2 clinical trial of AG013 for oral mucositis

Published 04 September 2017

Oragenics has announced that the first patient has been dosed in its Phase 2 clinical trial of AG013 for the treatment of oral mucositis (OM).

“We are very excited to dose the first patient and initiate the Phase 2 trial of AG013 for oral mucositis, one of the most common and debilitating complications of chemo-radiation therapies. With no approved preventative treatment, oral mucositis represents a serious unmet need that we hope to help overcome,” said Alan Joslyn, Oragenics’ President and Chief Executive Officer.

“The initiation of the trial represents a significant milestone for Oragenics. We expect to report preliminary data on the initial 20 enrolled patients by the end of 2017 with completion and full results of the trial expected by the end of 2018.”

The Phase 2 clinical trial of AG013 is a double-blind, placebo-controlled study that will be conducted at approximately 30 sites across the United States and Europe, and is expected to enroll up to 200 patients.

The purpose of the study is to evaluate the efficacy, safety and tolerability of administered AG013 compared to placebo for reducing OM in patients undergoing chemo-radiation for the treatment of head and neck cancer, as measured by the duration, time to development, and overall incidence of OM.

AG013 is an ActoBiotics therapeutic candidate formulated as a convenient oral rinsing solution and designed by our strategic collaboration partner Intrexon Corporation to deliver the therapeutic molecule Trefoil Factor 1 to the mucosal tissues in the oral cavity.

Trefoil Factors are a class of peptides involved in the protection of gastrointestinal tissues against mucosal damage and play an important role in subsequent repair. AG013 received Fast Track designation from the U.S. Food and Drug Administration (FDA) in November 2016.

Under an Exclusive Channel Collaboration Agreement with Intrexon, Oragenics has an exclusive worldwide license to develop and commercialize AG013 to treat OM in cancer patients.

Source: Company Press Release