Oragenics Appoints William “Frank” Peacock MD as Chief Clinical Officer
22 Mai 2024 - 2:00PM
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.
William “Frank” Peacock as its Chief Clinical Officer, who will
conduct its anticipated Phase II clinical trial for
treating concussion in the Emergency Department (“ED”). Oragenics’
lead drug candidate, ONP-002, is combined with its intranasal
device intended for the treatment of mild Traumatic Brain Injury
(mTBI), commonly known as concussion, in the field and emergency
departments. 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.
Dr. Peacock is currently the Vice Chair for
Emergency Medicine Research at Baylor College of Medicine and a
past Professor at the Cleveland Clinic Lerner College of Medicine.
He is also the Principal Investigator of a trial for a company
developing blood biomarkers for the identification of concussion in
the emergency department, which is analyzing acute blood markers
that are elevated after concussion to not only ensure concussion is
identified but also as a predictor of potential severity and
longer-term complications. Dr. Peacock is a world-renowned speaker
and researcher. He has been instrumental in the approval and use of
high sensitivity blood troponins for acute coronary syndrome
failure in emergency settings, which can be seen in the JAMA
Cardiology publication, Efficacy of High-Sensitivity Troponin T in
Identifying Very-Low-Risk Patients with Possible Acute Coronary
Syndrome, and he is the editor of the first book of “Biomarkers of
Traumatic Brain Injury”.
“I am excited to join Oragenics as its Chief
Clinical Officer at such an important and pivotal time in the
company’s clinical program. I have been involved with concussion
care in the emergency department throughout my 30-plus-year career.
My role with the HeadSMART blood biomarker trial has shown me that
we need biomarkers to trigger a treatment in the ER. We are
searching for that treatment, and I am looking forward to testing
ONP-002 to help determine if it can improve patient outcomes in our
upcoming Phase II clinical trials,” said Dr. Peacock.
“We are fortunate to have such an esteemed
emergency medicine physician and researcher join our team in this
important role at Oragenics. Given his understanding of blood
biomarkers, throughout his career, his intimate knowledge in
emergency medicine protocols and close ties with leading enrollment
centers for TBI clinical research, we believe he will play an
invaluable role in the success of Oragenics and planned Phase II
trials. We are currently working with Avance Clinical, CRO, for our
Phase II trial,” stated Michael Redmond, President of
Oragenics.
In preclinical animal models, ONP-002 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. The Phase II trial is designed to
establish a time to first dose, relationships between drug
application and blood biomarker levels, and the evaluation of
patient symptom severity in the first few hours and days after
injury,” said Dr. Peacock.
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 OragenicsOragenics 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 StatementsThis
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
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