NeOnc Technologies Holdings, Inc., a clinical-stage medical
biotechnology company, has begun enrollment of patients for Cohort
3 out of 6 of the Phase 1 clinical trial of NEO212™, the company’s
patented novel hybrid drug designed to deliver a ‘double punch’
against primary and secondary malignant brain tumors.
The advancement to Cohort 3 follows successful
completion of the first two cohorts. The company anticipates the
final cohort to be completed by the end of December.
The company earlier announced that the FDA
authorized NeOnc to initiate Phase 1 and 2 clinical trials of
NEO212. The Phase 1 portion of the clinical trial is an open-label
3+3 oral dose escalation of NEO212. The inclusion criteria targets
all comers with either primary or secondary solid intracranial
tumors.
“Now that we are nearly halfway through our Phase
1 clinical trial of NEO212, we are encouraged that NEO212 may
eventually impact the standard of care for primary brain tumors and
other cancers that can spread to the brain,” commented NeOnc CEO,
Thomas Chen, MD, Ph.D.
NEO212 combines the DNA alkylating agent
Temozolomide (TMZ) with NEO100™, NeOnc’s leading drug candidate
that is a proprietary, highly purified formulation of Perillyl
Alcohol (POH). NEO212 was designed to increase the efficacy of TMZ
through oral delivery using the conjugated formulation.
Merck’s patent protection of temozolomide expired
in 2009, enabling it to be produced as a generic drug. Sales of TMZ
exceeded an estimated $1.5 billion last year.
"Our preclinical animal studies suggest that
NEO212 may be less toxic and could potentially penetrate the
blood-brain barrier three times more efficiently and with ten times
the potency of TMZ—the current standard of chemotherapeutic care,”
noted Dr. Chen.
NeOnc's executive chairman, Amir Heshmatpour,
added: “We are confident that our clinical trials will validate the
result from our pre-clinical research studies conducted by Dr. Chen
and our USC Keck Medical School PhD teams, and propel our
proprietary drug development and delivery platform toward
commercialization.”
NEO212 also addresses brain metastasis, as the
most common type of brain tumor, with primary cancers, such as
lung, breast and melanoma, most likely metastasizing to the
brain.
An estimated 8%-10% of patients with systemic
cancers will develop brain metastases representing approximately
200,000 new patients with brain metastases annually, according to
the American Association of Neurological Surgeons. For patients
with malignant brain tumors, the five-year relative survival rate
following diagnosis remains at less than 36%.
These factors are driving the therapeutics market
for brain metastasis to grow at a projected 7.8% CAGR to reach $6.9
billion by 2033.
The biotechnology strides 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.
The NEO212 clinical trial is titled, ‘Open-Label,
Phase 1/2 Dose Finding, Safety and Efficacy Study of Oral NEO212 in
Patients with Astrocytoma IDH-Mutant, Glioblastoma IDH-Wildtype or
Uncontrolled Metastasis to the Brain in Patients with Select Solid
Tumors.’
The company recently announced that its Phase 2a
clinical trial of NEO100-01™, titled, 'An Open-Label, Phase 1/2a
Dose Escalation Study of Safety and Efficacy of NEO100 in Recurrent
Grade IV Glioma,’ was expanded from Grade IV to Grade III
Astrocytoma with IDH1 mutation.
The clinical trials advance the R&D of NEO™
technology platform and its ability to produce novel drugs and
delivery methods designed to address the persistent challenges with
overcoming the blood-brain barrier.
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 COO NeOnc Technologies Holdings,
Inc. Email Contact
NeOnc Investor Relations:
Ron Both or Grant Stude CMA Investor Relations Tel (949)
432-7566 Email Contact
NeOnc Media & ESG
Contact: Tim Randall CMA Media Relations
Tel (949) 432-7572 Email Contact
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