NeOnc Technologies Holdings, Inc., a clinical-stage medical
biotechnology company, has begun patient enrollment for the Phase 2
clinical trial of NEO100-02™, the company’s first of two drug
candidates proceeding through four concurrent clinical trials for
various indications and patient populations.
The Phase 2 study of NEO100-02 seeks further safety and
preliminary evidence of the biological effects of the novel drug on
patients afflicted with residual, progressive or recurrent
high-grade meningioma.
Meningioma is the most common type of benign tumor that forms in
the brain. They grow from the membranes that surround the brain and
spinal cord, with such growth potentially pressing on the nearby
brain, nerves and blood vessels. Like any tumor, it may become
atypical or malignant. Meningiomas may also develop in areas of the
brain which are difficult to operate upon, such as at the base of
the skull.
Approximately 97 out of every 100,000 people will be diagnosed
with meningioma sometime during their lifetime, according to the
Cleveland Clinic, with this resulting in more than 170,000 people
diagnosed with meningioma annually in the United States.
“Addressing the unique challenges posed by skull-base
meningiomas, this trial is tailored to a population with limited
alternative treatment options,” commented NeOnc CEO, Thomas Chen,
MD, Ph.D. “The difficulty in accessing these tumors frequently
results in significant neurological deficits post-surgery, and
traditional radiation therapy often proves ineffective.”
NeOnc novel intranasal delivery method for NEO100-02 offers an
easier alternative for patients compared to traditional approaches,
such as pills, injections and radiation. Radiation treatment and
chemotherapy for high-grade gliomas are complex, time-consuming,
and often result in poor prognoses.
“Such factors highlight the crucial need for developing
effective therapies that are less invasive and more
tolerable—particularly for the more vulnerable elderly and
pediatric populations,” noted Dr. Chen.
NeOnc’s intranasal delivery method is designed to allow drugs to
bypass the challenging blood-brain barrier and enter the brain
through the olfactory or trigeminal nerves. Intranasal drug
delivery is non-invasive and can be easily administered by or for
the patient. This can potentially reduce treatment costs and
improve treatment efficacy.
Intranasal delivery can also potentially enable rapid onset of
action and avoidance of first-pass metabolism efficacy decrease.
NEO100 intranasal delivery is anticipated to provide oncology
physicians and CNS chemo-therapeutic manufacturers with the vehicle
they have long sought to impact the efficacy of their treatment
protocols.
Progressing under FDA Fast-Track, Orphan Drug (OD) and
Investigational New Drug (IND) status, this new Phase 2 clinical
trial is titled, ‘An Open-Label, Phase 2 Study of NEO100-02 in
Participants with Residual, Progressive or Recurrent High-grade
Meningioma.’
The new clinical trial represents NeOnc's second Phase 2
clinical trial in addition to two Phase 1 trials. The trials are
for various indications and potential patient groups, and are
proceeding simultaneously.
NeOnc’s other ongoing Phase 2a clinical trial for NEO100-01 is
titled, ‘An Open-Label, Phase 1/2a Dose Escalation Study of Safety
and Efficacy of NEO100 in Recurrent Grade IV Glioma.’ The study was
recently expanded from Grade IV Astrocytoma with IDH1 mutation to
include the more prevalent but equally lethal Grade III
variant.
NeOnc's executive chairman, Amir Heshmatpour, commented: “We
believe this initiation of our Phase 2 meningioma clinical trial
for NEO100-02, along with our lead Phase 2 clinical trials for
NEO100-01 also currently underway, strengthens the value of our
proprietary drug development platform.
“The various indications and patient groups we can address
highlight the fact we enjoy multiple ‘shots on goal’ as we pursue
commercialization, which we believe also significantly increases
our shareholder value.”
NEO100 is a proprietary, highly purified formulation of Perillyl
Alcohol (POH) which is found in the essential oils of certain
plants, such as citrus.
The biotechnology advancements generated by NeOnc's NEO™ drug
development platform is the result of more than a decade of
research at the University of Southern California (USC) by Dr. Chen
and his medical and scientific teams.
About NeOnc Technologies Holdings
NeOnc Technologies is a privately held clinical stage life
sciences company focused on the development and commercialization
of central nervous system therapeutics that are designed to address
the persistent challenges in overcoming the blood-brain
barrier.
The company’s NEO™ drug development platform has produced a
portfolio of novel drug candidates and delivery methods with patent
protections extending to 2038. These proprietary chemotherapy
agents have demonstrated positive effects in laboratory tests on
various types of cancers and in clinical trials treating malignant
gliomas. NeOnc’s NEO100™ and NEO212™ therapeutics are in Phase I
and II human clinical trials, and are advancing under FDA
Fast-Track and Investigational New Drug (IND) status.
The company has exclusively licensed an extensive worldwide
patent portfolio from the University of Southern California
consisting of issued patents and pending applications related to
NEO100, NEO212, and other products from the NeOnc patent family for
multiple uses, including oncological and neurological
conditions.
For more about NeOnc and its pioneering technology, visit
neonctech.com.
Important Cautions Regarding Forward-Looking
Statements
All statements other than statements of historical facts
included in this press release are "forward-looking statements" (as
defined in the Private Securities Litigation Reform Act of 1995).
Generally, such forward-looking statements include statements
regarding our expectations, possible or assumed future actions,
business strategies, events, or results of operations, including
statements regarding our expectations or predictions or future
financial or business performance or conditions and those
statements that use forward-looking words such as "projected,"
"expect," "possibility" and "anticipate," or similar expressions.
The achievement or success of the matters covered by such
forward-looking statements involve significant risks,
uncertainties, and assumptions. Actual results could differ
materially from current projections or implied results.
NeOnc Technologies Holding, Inc. (the "Company") cautions that
statements and assumptions made in this news release constitute
forward-looking statements without guaranteeing future performance.
Forward-looking statements are based on estimates and opinions of
management at the time statements are made. The information set
forth herein speaks only as of the date hereof. The Company and its
management are under no obligation, and expressly disclaim any
responsibility, to update, alter, or otherwise revise any
forward-looking statements following the date of this news release,
whether because of new information, future events, or otherwise,
except as required by law.
NeOnc Company Contact: Patrick
Walters Chief Operations OfficerNeOnc Technologies Holdings,
Inc. Email Contact
NeOnc Investor Relations: Ron Both or
Grant StudeCMA Investor Relations Tel (949)
432-7566 Email Contact
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