U.S. FDA Grants Fast Track Designation for the Development of Oragenics’ AG013 for Oral Mucositis
November 21 2016 - 3:29PM
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
the U.S. Food and Drug Administration (FDA) granted Fast Track
designation to AG013, the Company’s lead therapeutic candidate for
the treatment of OM. Oragenics expects to file an Investigational
New Drug (IND) update and initiate a Phase 2 study with AG013 in
the United States and Europe in early 2017.
Fast Track is a process designed to facilitate the development
and review of drugs to treat serious conditions and address key
unmet medical needs by allowing for more frequent meetings and
communications with the FDA. It also provides eligibility
submission of a New Drug Application (NDA) on a rolling basis as
well as Accelerated Approval and Priority Review.
“We are pleased that AG013 has received this Fast Track
designation which aims to help get important new drugs for unmet
clinical needs to patients earlier,” said Alan Joslyn, Oragenics’
Chief Executive Officer and President. “This is another significant
milestone in the path providing a new therapy for cancer patients
who develop oral mucositis.”
AG013 is an ActoBiotics™ therapeutic candidate formulated as a
convenient oral rinsing solution and designed by Intrexon
Corporation (NYSE: XON) to deliver the therapeutic molecule Trefoil
Factor 1 (TFF1) to the mucosal tissues in the oral cavity. Trefoil
Factors are a class of peptides involved in protection of
gastrointestinal tissues against mucosal damage and have an
important role in subsequent repair. In addition to this Fast Track
designation, AG013 has already been granted Orphan Drug status in
the European Union.
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 versus 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.
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.
About Oral Mucositis (OM)
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.
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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version on businesswire.com: http://www.businesswire.com/news/home/20161121005390/en/
OragenicsCorporate Contact:Michael Sullivan,
813-286-7900Chief Financial
Officermsullivan@oragenics.comorInvestor/Media Contact:The Ruth
GroupDavid Burke, 646-536-7009dburke@theruthgroup.com
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