A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Topically-applied AG013 for the Attenuation of Oral Mucositis in Subjects With Cancers of the Head and Neck Receiving Concomitant Chemoradiation Therapy
Phase of Trial: Phase II
Latest Information Update: 04 Aug 2017
At a glance
- Drugs AG 013 (Primary)
- Indications Stomatitis
- Focus Adverse reactions; Therapeutic Use
- Sponsors Oragenics Inc
- 28 Jul 2017 Status changed from planning to recruiting.
- 18 Apr 2017 According to an Oragenics media release, the company has submitted an IND amendment for this phase II trial. The company has provided the US FDA with the updated protocol for this trial, including the identification of the trial sites in the United States and the manufacturing details of the product material.
- 09 Nov 2016 According to an Intrexon media release, US FDA has provided as feedback to the request for a Type C meeting concerning protocol of this Phase 2 study.