On March 15, 2019 Oragenics, Inc. (NYSE American: OGEN), a leader in the development of new antibiotics against infectious diseases and effective treatments for oral mucositis, reported the enrollment of the 60th patient in its Phase 2 double blind, placebo controlled clinical trial of AG013 (NCT03234465) (Press release, Oragenics, MAR 15, 2019, View Source [SID1234534401]).
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AG013 is an oral mouth rinse composed of a recombinant Lactococcus lactis bacteria strain that contains the coding sequence for human trefoil family factor 1 (hTFF1), which is continually secreted by the bacteria. The trefoil factor family (TFF) is a family of three different peptides secreted by epithelial cells of the gastrointestinal tract in response to injury (Hoffman, 2004). Their presence has been implicated in reducing chemotherapy- and radiation-induced injury, both in preclinical studies (Beck et al., 2004) and in clinical trials (Peterson et al., 2009).
"We are encouraged and pleased to have made this important intermediate progress. The number of patients interested in participating in the clinical trial highlights the need for new treatment options for prevention of severe oral mucositis in this patient population," said Alan Joslyn, CEO of Oragenics, Inc. "While we are confident in the measures we have taken to potentially expedite the pace of patient enrollment in future periods and we remain optimistic about such enrollment rates, given the pace of patient enrollment to date, we now anticipate that the top-line data readout of the AG013 study will likely occur in early 2020."