Oragenics Appoints James Kelly MD, Chief Medical Officer, to Lead Phase II Clinical Trials for Treating Concussion
March 18 2024 - 7:00AM
Business Wire
Oragenics, Inc. (NYSE American: OGEN), a company focused on
developing unique, intranasal pharmaceuticals for the treatment of
neurological disorders, today announced it has appointed Dr. James
“Jim” Kelly, Neurologist, as its Chief Medical Officer, to oversee
its upcoming Phase II clinical trial. Oragenics’ lead drug
candidate, ONP-002 is combined with its intranasal device intended
for the treatment of mild Traumatic Brain Injury (TBI), aka
concussion. ONP-002 is a new chemical entity (NCE) designed to
target the brain through delivery into the nasal cavity and onward
to the brain. A 40-patient Phase I study was completed and showed
the drug to be safe and well-tolerated.
In the recent past, Dr. Kelly served as the Executive Director
of the Marcus Institute for Brain Health (MIBH) and Professor of
Neurology at the University of Colorado Anschutz Medical Campus in
Aurora, Colorado. The MIBH specialized treatment program is funded
by the Marcus Foundation to care for US military veterans with
persistent symptoms of TBI. Dr. Kelly was also National Director of
the Avalon Action Alliance TBI Programs for which the MIBH serves
as the clinical coordinating center.
“I am excited to join Oragenics as its Chief Medical Officer at
such an important and pivotal time in the drug development process.
I have been involved with the drug for many years now and look
forward to testing the drug and showing it can improve patient
outcomes in our upcoming Phase II clinical trials,” said Dr.
Kelly.
Prior to these recent positions, Dr. Kelly was the Director of
the National Intrepid Center of Excellence (NICoE) at Walter Reed
National Military Medical Center in Bethesda, MD. As its founding
Director, he led the creation of an innovative interdisciplinary
team of healthcare professionals who blended high-tech diagnosis
and treatment with complementary and alternative medical
interventions in a holistic, integrative approach to the care of US
military personnel with the complex combination of TBI and
psychological conditions, such as post-traumatic stress,
depression, and anxiety. In this role, Dr. Kelly was frequently
called upon by leaders of the Military Health System at the
Pentagon, the US Congress, the Department of Veterans Affairs, and
numerous military facilities in the continental US and abroad. Dr.
Kelly has interacted with the FDA and clinical trials for brain
injury throughout his esteemed career. He is a strong advocate for
treatments in the acute phase of brain injury and understands the
value of protecting the brain early on from inflammation, swelling
and oxidative stress to gain better clinical outcomes.
“We are fortunate to have such an esteemed neurologist as Dr.
Kelly join our team in this important role at Oragenics. Dr. Kelly
is recognized as a leading expert in concussion and other brain
injuries and we are fortunate to have him lead our drug trials
going forward. We are currently completing the drug manufacturing
and formulation at GMP facilities to ensure the integrity of the
drug before and during the trials, and we look forward to
completing this work in the short-term and getting the Phase II
trial underway,” stated Michael Redmond, President of
Oragenics.
In preclinical animal models, the drug has been shown to acutely
improve molecular and behavioral outcomes following brain injury.
In addition, intranasal delivery of the drug as a nanoparticle has
been shown to enhance brain exposure and metabolism in animals.
“Our Phase I human study has shown ONP-002 to be well tolerated in
humans. Our mission now is to show that the ONP-002 brain
protective mechanisms in animals translates to humans. Our Phase II
study is designed to establish time to first dose, relationships
between drug application and blood biomarkers, and the evaluation
of clinical endpoints to determine improved in patient outcomes, ”
said Dr. Kelly.
Concussion is an unmet medical need. There is 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.
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 the 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
retain its key employees and independent contractors necessary to
continue to develop its product candidates and in particular
ONP-002 and the availability of those key employees and independent
contractors; the Company’s ability to raise capital and obtain
funding, non-dilutive or otherwise, for the development of its
product candidates; the Company’s expectations as to the outcome of
the Phase II clinical trial 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.
Released March 18, 2024
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240318916780/en/
Oragenics, Inc. Janet Huffman, Chief Financial Officer
813-286-7900 jhuffman@oragenics.com
LHA Investor Relations Tirth T. Patel 212-201-6614
tpatel@lhai.com
Oragenics (AMEX:OGEN)
Historical Stock Chart
From Jun 2024 to Jul 2024
Oragenics (AMEX:OGEN)
Historical Stock Chart
From Jul 2023 to Jul 2024