Oragenics Receives Supportive FDA Feedback for Initiating a Phase 2 Study Protocol for Oral Mucositis Treatment
August 30 2016 - 8:15AM
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.
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: our current need for financing to
meet our operational needs and to be able to move our product
candidates forward through pre-clinical and clinical development;
our inability to obtain sufficient financing to conduct our
business; any inability to obtain or delays in the FDA’s approval
of clinical studies and testing; the future success of our studies
and testing and any inability to also achieve favorable results in
human studies; our ability to successfully develop and
commercialize products; the financial resources available to us to
continue research and development and the allocation of such
resources among our product candidates: any inability to regain
compliance with the NYSE MKT continued listing requirements and
those other factors described in our filings with the U.S.
Securities and Exchange Commission. Any responsibility to update
forward-looking statements is expressly disclaimed.
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OragenicsCorporate Contact:Michael Sullivan,
813-286-7900Chief Financial Officermsullivan@oragenics.comorThe
Ruth GroupInvestor/Media Contact:David Burke,
646-536-7009dburke@theruthgroup.com
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