Oragenics Partners with Avance Clinical for Phase II Concussion Trial in Australia
May 07 2024 - 8:00AM
Oragenics, Inc. (NYSE American: OGEN), a pioneer in developing
innovative intranasal pharmaceuticals for neurological disorders,
today announced a partnership with Avance Clinical, a leading
Contract Research Organization (CRO), to conduct a Phase II
clinical trial in Australia. This trial aims to evaluate Oragenics'
lead drug candidate, ONP-002, for mild Traumatic Brain Injury
(TBI), commonly known as concussion. ONP-002, a novel chemical
entity (NCE), is delivered through a unique intranasal device and
designed to maximize drug delivery directly to the brain.
Avance Clinical, renowned for its clinical trial
management capabilities and quality of service in Australia, New
Zealand, and North America, brings over two decades of expertise in
navigating the Therapeutic Goods Administration, Food and Drug
Administration, and European Medicines Agency regulatory
landscapes. An Oragenics Phase I clinical trial, recently completed
in Australia under the management of Avance Clinical, demonstrated
that ONP-002 is safe and well-tolerated.
"Concussion remains a significant unmet medical
need," said Dr. Jorgen Mould, Senior Director of Scientific and
Regulatory Services at Avance Clinical. "Oragenics is poised to
address this challenge, and we are delighted to be part of the
team, especially given Australia's high incidence of sports-related
concussions."
Michael Redmond, President of Oragenics, added,
"Our collaboration with Avance Clinical during the Phase I trial
was instrumental, and we are confident in their ability to execute
an effective Phase II trial that will pave the way for future
treatment protocols for concussion."
Dr. James Kelly, Neurologist and Chief Medical
Officer at Oragenics, emphasized the critical role of the
Australian medical community: "Australia has been at the forefront
of diagnosing and treating head injuries. We are fortunate to work
with such skilled medical professionals in conducting this pivotal
research."
Concussion is an unmet medical need. There are
an estimated 69 million concussions annually reported worldwide.
Common causes of concussion include falls, motor vehicle accidents,
and contact sports. Other neurological disorders, including
Alzheimer’s Disease, Parkinson’s Disease, and Chronic Traumatic
Encephalopathy (CTE), have been linked to concussion. Post
concussion syndrome is linked to long-term disability and occurs in
as high as 20% of concussed patients.
About Oragenics
Oragenics is a development-stage biotechnology
company focused on nasal delivery of pharmaceutical medications in
neurology and fighting infectious diseases, including drug
candidates for treating mild traumatic brain injury (mTBI), also
known as concussion, and for treating Niemann Pick Disease Type C
(NPC), as well as proprietary powder formulation and an intranasal
delivery device. For more information, please
visit www.oragenics.com.
Forward-Looking Statements
This communication contains “forward-looking
statements” within the meaning of the safe harbor provisions of the
U.S. Private Securities Litigation Reform Act of 1995, including
without limitation statements regarding the ability of the Company
to timely and successfully undertake Phase II clinical trial using
its novel drug-device combination for the treatment of mild
Traumatic Brain Injury. 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: the
Company’s ability to advance the development of its product
candidates, including the neurology assets, under the timelines and
in accord with the milestones it projects; the Company’s ability to
raise capital and obtain funding, non-dilutive or otherwise, for
the development of its product candidates; the regulatory
application process, research and development stages, and future
clinical data and analysis relating to its product candidates,
including any meetings, decisions by regulatory authorities, such
as the FDA and investigational review boards, whether favorable or
unfavorable; the Company’s ability to obtain, maintain and enforce
necessary patent and other intellectual property protection; the
nature of competition and development relating to concussion
treatments; the Company’s expectations as to the outcome of
preclinical studies and clinical trials and the potential benefits,
activity, effectiveness and safety of its product candidates
including as to administration, transmission, manufacturing,
storage and distribution; and general economic and market
conditions and risks, as well as other uncertainties described in
our filings with the U.S. Securities and Exchange Commission. All
information set forth is as of the date hereof unless otherwise
indicated. You should consider these factors in evaluating the
forward-looking statements included and not place undue reliance on
such statements. We do not assume any obligation to publicly
provide revisions or updates to any forward-looking statements,
whether as a result of new information, future developments or
otherwise, should circumstances change, except as otherwise
required by law.
Oragenics, Inc.Janet Huffman, Chief Financial
Officer813-286-7900jhuffman@oragenics.com
LHA Investor RelationsTirth T.
Patel212-201-6614tpatel@lhai.com
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