Study to Assess Safety and Tolerability of AG013 in Oral Mucositis in Subjects Receiving Induction Chemotherapy for the Treatment of Cancers of the Head and Neck

• Safety (Adverse Events, laboratory assessments and the presence of sAGX0085 bacteria in blood) [ Time Frame: 16 months ] [ Designated as safety issue: Yes ]
  Up to 16 months
  
  

• Pharmacokinetics of serum samples, buccal smears and saliva samples [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  Day 1 CT cycle 2, Day 7 CT cycle 2, Day 14 CT cycle 2, End of Study
  
  

The purpose of this study is to investigate the safety and tolerability of AG013 in subjects who are at risk for oral mucositis (OM) and to assess clinical efficacy of AG013 in the reduction of signs and symptoms of OM in patients receiving induction chemotherapy for the treatment of their head and neck cancer.

AG013 is made up of genetically modified (GM) bacteria called Lactococcus lactis (L. lactis). Wild type L. lactis are commonly used to produce dairy products including cheeses and milk. To make AG013, the DNA of L. lactis has been changed in the laboratory to secrete a protein called human Trefoil Factor 1 (hTFF1). hTFF1 is normally secreted in saliva and intestines. Trefoil factors have been shown to be important in protecting and healing mucosal tissues, such as the tissue in the mouth, when these tissues are damaged by cancer therapies such as chemotherapy and radiation therapy.

The proposed Phase 1b clinical trial will enroll subjects with head and neck cancer who develop OM during their first cycle of treatment with induction chemotherapy. OM is a painful, common toxicity of many forms of drug and radiation therapy used for the treatment of cancer. Subjects with OM get soreness, irritation, and ulcers in the mouth and may have difficulties eating, drinking or swallowing as a result of their cancer treatment.

During the second cycle of induction chemotherapy, eligible subjects will receive AG013 or placebo for 14 consecutive days at a frequency of one rinse, three rinses or six rinses per day (sequential dose escalation design).

At least 21 subjects will be enrolled in the study. For each of the three daily dose levels, 5 subjects will be assigned to AG013 (n=5) and 2 subjects will be assigned to placebo (n=2).

Throughout the study, safety will be monitored by collecting and recording Adverse Events, laboratory assessments and the presence of sAGX0085 bacteria in blood.

An independent Data Safety Monitoring Board (DSMB) will be constituted before the enrollment of subjects in order to review safety data from each enrollment group.