Full Press Release Details
Inc. Announces Early Top-Line Results of Phase 2 Clinical Trial of AG013 for Oral Mucositis in Chemoradiation Treatment of Head
Fla-April 15, 2020 - Oragenics, Inc. (NYSE American: OGEN), a leader in the development of new antibiotics against
infectious diseases and effective treatments for oral mucositis, announced today that early top-line results of the company's
Phase 2 clinical trial of AG013 in oral mucositis in chemoradiation in head and neck cancer patients did not demonstrate statistical
significance on the primary endpoint of severe oral mucositis duration when compared to placebo. AG013 was found to be safe based
on review of topline adverse event information.
Joslyn, Ph.D., president and CEO of Oragenics stated, "We have now received the first cut of top line results for the study
of AG013 in the prevention of oral mucositis in chemoradiation treatment of head and neck cancer. The results are equivocal in
relation to the efficacy outcomes and we now await a more detailed ongoing analyses to determine if there may be potential efficacy
for sub-patient populations, which we expect over the coming weeks."
Inc. is focused on becoming a leader in novel antibiotics against infectious disease and on developing effective treatments for
oral mucositis. Oragenics has an exclusive worldwide channel collaboration with ActoBio, a wholly-owned subsidiary of Precigen,
Inc. The collaboration allows Oragenics to accelerate the development of microbe-based biotherapeutics for oral mucositis. Oragenics
also has a collaboration with ILH Holdings, Inc. focused on the development of a novel class of antibiotics.
more information about Oragenics, please visit www.oragenics.com.
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.
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