Oragenics Receives Supportive FDA Feedback for Initiating a Phase 2 Study Protocol for Oral Mucositis Treatment

TAMPA, Fla.–(BUSINESS WIRE)–Oragenics
(NYSE MKT: OGEN.BC), a leader in the development of novel antibiotics
against infectious disease and developing effective treatments for oral
mucositis (OM) today announced that it has received feedback from the
U.S. Food and Drug Administration (FDA) in response to the Company’s
request for a Type C meeting, concerning Phase 2 study protocols for the
Company’s OM therapeutic candidate, AG013. As part of the clinical
protocol for the study, Oragenics expects to file the Investigational
New Drug (IND) update in late 2016 and initiate the study with AG013 in
the United States and Europe during early 2017.
“We are pleased to have the FDA’s thorough feedback on protocol design
for our Phase 2 trial and drug product manufacturing requirements for
evaluating AG013 for the treatment of oral mucositis,” said Alan Joslyn,
Oragenics’ Chief Executive Officer and President. “This is an important
milestone in our effort to potentially provide cancer patients with a
new therapy for treatment of oral mucositis.”
OM results in a painful inflammation and mucosal ulceration in the
lining of the oral cavity, throat and esophagus and is one of the most
commonly reported adverse events associated with cancer chemotherapy
affecting up to 500,000 patients annually. OM has a negative effect on
patient well-being and if severe, negatively affects a patient’s cancer
treatment regimen. At present, no drug is approved to prevent the
condition broadly and current therapies are primarily palliative in
nature, only addressing symptom relief but not treating the underlying
causes of the condition.
“Oral mucositis remains a major unmet need for cancer patients receiving
cytotoxic radiation and chemotherapy,” said Stephen T. Sonis, DMD, DMSc,
Senior Surgeon, Divisions of Oral Medicine, Brigham and Women’s Hospital
and the Dana-Farber Cancer Institute. Dr. Sonis continued, “As suggested
by the results of pre-clinical and clinical studies, AG013 may provide a
unique delivery platform for an effective intervention. I’m excited that
its development program has completed this important first step in
moving forward.”
Through the genetic engineering of a food grade microbe, Lactococcus
lactis (L. lactis), by the Actobiotics Division of
Intrexon Corporation (NYSE: XON), in situ production and
secretion of peptide therapeutics has been developed, including AG013,
an oral rinsing solution designed to deliver human Trefoil Factor 1
(hTFF1) to protect and regenerate damaged mucosal lining of the oral
cavity. Under an Exclusive Channel Collaboration Agreement with
Intrexon, Oragenics has an exclusive worldwide license to develop and
commercialize AG013 to treat oral mucositis in cancer patients.
A Phase 1B clinical trial with AG013 in 25 head and neck cancer patients
at high risk for OM demonstrated that AG013 was safe and well tolerated.
Data published in the journal Cancer showed a 35% reduction in
the duration of ulcerative OM in AG013-treated patients vs placebo
treated patients. Additionally over 30% of patients treated with AG013
were complete responders, defined as patients who did not develop OM,
while all patients receiving placebo developed OM. A Phase 1
pharmacokinetic study in 10 healthy volunteers showed that live AG013 L.
lactis adhered to the entire oral mucosal surface up to 24 hours
after administration of the rinse.
AG013 has already been granted Orphan Drug status in the European Union
and applications for Biologic License Application exclusivity and Fast
Track designation with the FDA will be filed in the coming months.
About the Study Design
The Phase 2 double blind placebo controlled trial has been designed to
evaluate the efficacy, safety, and tolerability of AG013 in patients
being treated with standard regimens of concomitant chemoradiation
therapy for common cancers of the head and neck. Not only is severe
mucositis among the most common complications of treatment in this
population, but its impact on patients’ ability to tolerate cancer
therapy and risk of adverse health and resource use outcomes are
frequent and devastating. Oragenics expects to announce additional
information about the study design and timelines for the study once they
are finalized.
About Oragenics, Inc.
We are focused on becoming the world 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, a synthetic biology
company. The collaborations allow Oragenics access to Intrexon’s
proprietary technologies toward the goal of accelerating 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, www.oragenics.com.
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