Oragenics, Inc. Announces Enrollment of 60th Patient in Clinical Trial

TAMPA, Fla.–(BUSINESS WIRE)–Oragenics, Inc. (NYSE American: OGEN), a leader in the development of
new antibiotics against infectious diseases and effective treatments for
oral mucositis, today announces the enrollment of the 60th
patient in its Phase 2 double blind, placebo controlled clinical trial
of AG013 (NCT03234465).

AG013 is an oral mouth rinse composed of a recombinant Lactococcus
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,
). 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.”

About Oragenics, Inc.

We are focused on becoming a leader in novel antibiotics against
infectious disease and on developing effective treatments for oral
mucositis. Oragenics, Inc. has established two exclusive worldwide
channel collaborations with Intrexon Corporation and its subsidiaries.
The collaborations allow Oragenics to accelerate the development of much
needed new antibiotics that can work against resistant strains of
bacteria and the development of biotherapeutics for oral mucositis and
other diseases and conditions of the oral cavity, throat, and esophagus.

For more information about Oragenics, please visit www.oragenics.com.

Safe Harbor Statement: Under the Private Securities Litigation
Reform Act of 1995: This release includes forward-looking statements
that reflect management’s current views with respect to future events
and performance. These forward-looking statements are based on
management’s beliefs and assumptions and information currently
available. The words “believe,” “expect,” “anticipate,” “intend,”
“estimate,” “project” and similar expressions that do not relate solely
to historical matters identify forward-looking statements. Investors
should be cautious in relying on forward-looking statements because they
are subject to a variety of risks, uncertainties, and other factors that
could cause actual results to differ materially from those expressed in
any such forward-looking statements. These factors include, but are not
limited to, risks and uncertainties described in our filings with the
U.S. Securities and Exchange Commission. Oragenics assumes no
responsibility to update any forward-looking statements contained in
this press release or with respect to the matters described herein.


Oragenics, Inc.
Michael Sullivan,
Chief Financial Officer
[email protected]


John Marco
Managing Director
[email protected]

Jules Abraham
[email protected]

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