Market Overview

Oragenics, Inc. Resumes Phase 2 Clinical Trial of AG013 in Oral Mucositis Following Positive Routine Safety Review


Oragenics, Inc. (NYSE:OGEN), a leader in the development of
new antibiotics against infectious diseases and effective treatments for
oral mucositis (OM), today announced it has resumed its Phase 2 clinical
trial of AG013, a live biotherapeutic product for the potential
treatment of OM following a positive review by an independent Data
Safety Monitoring Board (DSMB).

"Based on the DSMB's positive review, and using funds recently raised
through a public offering, we are now expanding our Phase 2 trial to up
to 45 additional centers in the US and EU in order to rapidly accelerate
patient enrollment," stated Alan Joslyn, president and CEO of Oragenics,
Inc. "With our reinforced cash position, we look forward to completing
the trial next year while concurrently advancing our lantibiotic

In May 2018, Oragenics reported positive interim safety analysis results
based on the first 19 patients, which were evaluated on the basis of
treatment-emergent adverse events, vital signs, weight, physical
examination, clinical laboratory assessment and the potential presence
of AG013 in blood. Tolerability measures (taste, consistency and smell)
were collected from patient diaries. Following a routine data review,
the trial's independent DSMB concluded that it may proceed with no
necessary changes to the study.

The ongoing Phase 2 trial is a double-blind, placebo-controlled,
two-arm, multi-center trial, in which approximately 200 patients will be
randomized in a 1:1 ratio to receive either AG013 or placebo. The
purpose of the study (NCT03234465) is to evaluate the safety,
tolerability and efficacy of topically administered AG013 compared to
placebo for reducing the incidence and severity of OM in patients
undergoing traditional chemoradiation for the treatment of head and neck
cancer. Key measures include duration, time to development, and overall
incidence of OM (World Health Organization scale) during the active
treatment phase, which begins from the start of chemoradiation therapy
until two weeks following its completion.

AG013, which has been granted Fast Track designation with the U.S. Food
and Drug Administration and orphan drug status in Europe, is an
ActoBiotics® therapeutic candidate formulated to deliver the
therapeutic molecule Trefoil Factor 1 to the mucosal tissues in the oral
cavity in a convenient oral rinsing solution. 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.
The compound was designed by the company's strategic partner, ActoBio
Therapeutics, Inc., a wholly-owned subsidiary of Intrexon Corporation

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 allows 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

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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," "
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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.

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