NEONC Technologies Scientific and Clinical Advisory Board Plans Development
and Clinical Testing of NEO100 in Treatment of Gliomas and Other Cancers
LOS ANGELES -- February 7, 2013
NEONC Technologies, Inc. (NTI), an early-stage biotechnology company
developing new drugs using intranasal brain delivery, today announced that the
company’s NEO100 compound will undergo extensive clinical testing for
treatment of gliomas and other cancers of the central nervous system. The
clinical testing program was developed at meetings in Los Angeles on January
25-26 of the company’s Scientific and Clinical Advisory Board, consisting of
internationally prominent researchers and clinicians in the field of
Leadership in Nasal Brain Delivery
NEONC has conducted in-vitro and in-vivo testing, and built extensive
intellectual property around NEO100, a novel, highly purified form of the
monoterpene perillyl alcohol (POH). The clinical program will be led by Dr.
Thomas Chen, Founder, Chairman and CEO of NEONC, Co-Director, USC/Norris
Neuro-Oncology Program and Professor of Neurological Surgery and Pathology,
USC Keck School of Medicine. “Clinical research using intranasal delivery of
POH in patients with recurrent malignant gliomas has resulted in a
statistically significant increase in survival for patients with primary or
secondary brain cancers. Our vision is to become the pharmaceutical leader in
the promising technique of nasal brain delivery, which bypasses the
blood-brain barrier and can greatly decrease the side effects of anti-cancer
medication,” said Dr. Chen.
Unparalleled Success in Treating Deadly Brain Cancer
Malignant gliomas currently have no cure and are nearly always fatal to
patients within 12-15 months of diagnosis. Research in Brazil published in
April 2010 by Dr. Clovis da Fonseca and his team, who are also founders of
NEONC, in glioma patients using intranasal delivery of POH, demonstrated
unparalleled success treating this disease. The study included 89 adult
patients with recurrent malignant glioblastoma multiforme (GBM) and 52 matched
GBM patients in a historical untreated control group. Patients with recurrent
primary GBM survived significantly longer than the untreated group. Patients
with primary GBM treated with inhaled POH showed a survival advantage (5.9
months) compared with the control group (2.3 months). In addition, the side
effects of treatment were almost nonexistent, even in patients treated for
more than four years.
Advisory Board Creates Roadmap for Clinical Trials
“The power of Dr. Fonseca’s pioneering work on intranasal POH, and NEONC’s
development, testing and intellectual property protection of even more
effective inhaled compounds, have laid the groundwork to attract a highly
experienced Scientific and Clinical Advisory Board to support the company’s
upcoming clinical testing program,” said Dr. Vincent Simmon, Chief Regulatory
Officer of NEONC. “The Advisory Board has helped create a roadmap for clinical
testing that we believe can ultimately lead to pivotal trials to determine the
effectiveness of inhaled NEO100 in treating GBM.”
Members of the NEONC Scientific and Clinical Advisory Board include:
Dr. J Howard Bailey, MD -- Professor of Medicine, University of Wisconsin,
principal investigator on most of the initial oral POH trials from U of
Dr. Marc Chamberlain, MD -- Professor of Neurology, University of Washington,
a world renowned neuro-oncologist, well known for his work on leptomeningeal
Dr. Michael Davitz, MD, JD, Outside Patent Counsel -- Both a medical doctor
and a patent lawyer. Prior to starting his practice in patent law, Dr. Davitz
was an assistant professor in pathology. He combines his knowledge of medicine
and law as a patent attorney and partner of Axinn,Veltrop. He is the key
advisor for NEONC’s patent strategy.
Marc Giroux, Director of NEONC -- Currently Chairman and Chief Executive
Officer of Kurve Technology, Inc., a drug delivery device company and
development partner of NEONC. He is the inventor of the core delivery
technologies that are under commercialization at Kurve, with applications in
nasal, nose-to-brain, ocular, dermal, transdermal, throat, mouth and lung
therapies. Mr. Giroux is a successful serial entrepreneur. He leads Kurve's
business development efforts with investors and partners and guides product
Dr. Steven L. Giannotta, MD -- Professor and Chair of Neurosurgery, University
of Southern California, has clinical interests in vascular and skull base
surgery, for which he is internationally recognized. He is considering POH for
use in treatment of skull base tumors.
Dr. Michael Gould, PhD -- Professor of Medicine, University of Wisconsin, was
the investigator who initiated studies of POH as an anti-cancer agent.
Daniel Levin, PhD, CCHEM, FRSC -- President and R&D Director of Norac Pharma,
with extensive experience in pharmaceutical process R&D and manufacturing, has
helped in developing, manufacturing and testing POH formulations.
Dr. Victor Levin, MD, Anderson Cancer Center -- Considered the “Father of
American Neuro-oncology” with an illustrious career as an oncologist at UCSF
and MD Anderson; innovator, founder of Society of Neuro-Oncology and Founder
of Orbus Therapeutics, Inc.
Dr. Michael D Prados, MD, FACP -- Director of UCSF Department of Translational
Research, Dr. Prados has over 20 years' experience at UCSF in treating and
supervising the treatment of both adults and children who have brain tumors.
The National Cancer Institute's Adult Brain Tumor Consortium, which sponsors
trials of treatment regimens for brain tumors, is based at UCSF under Dr.
Prados' leadership, and he is principal investigator of the Pediatric Brain
Tumor Consortium site at UCSF, which is one of 7 institutions in the United
States selected to participate in this NIH-funded cooperative effort to
develop effective new strategies for treating children with malignant brain
Dr. David Peereboom, MD, The Cleveland Clinic -- Medical oncologist, focusing
on neuro-oncology and was involved in some of the initial oral POH studies.
Dr. Peereboom has an active practice at the Cleveland Clinic and is a
prominent member of Society of Neuro-Oncology.
Vincent F. Simmon, PhD -- Chairman of Personalized Pharmaceutical Systems, CRO
of NEONC. Dr. Simmon was formerly CEO of Xytis Pharmaceuticals, a privately
held biotechnology company focused on developing novel therapeutics to treat
central nervous system (CNS) diseases. Previously, Dr. Simmon was COO of
Merrimack Pharmaceuticals where he was responsible for progressing its lead
compound into Phase II clinical studies, and participated in raising more than
$95 million in private financing. Dr. Simmon also previously served as the
President and CEO of Cortex Pharmaceuticals, Inc. a publicly listed biotech
company based in Irvine, CA. Prior to Cortex, he served as CEO of Alpha 1
Biomedicals, Inc., and Viral Technologies, Inc. He has also served as Vice
President of Research and Development at W.R. Grace & Co. and Genex Corp.
Dr. Patrick Wen, MD -- Director of Cancer Neurology, Brigham and Women’s
Hospital, Director of Dana-Farber/Brigham and Women’s Cancer Center
Neuro-Oncology Disease Center, and Professor of Neurology, Harvard Medical
Dr. Florence Hofman, PhD -- Professor of Pathology, University of Southern
California; focus is on glioma endothelial cells. She is a world expert in
brain tumor research and brain endothelial cells.
Dr. Axel Schonthal, PhD -- Associate Professor of Microbiology, University of
Southern California; focus is on endoplasmic reticulum stress (ERS) and expert
on cell cycle regulation.
Dr. Gabriel Zada, MD -- Assistant Clinical Professor of Neurosurgery, Director
of endoscopic pituitary and skull base surgery at USC Norris Comprehensive
Cancer Center and Hospital.
Strong Strategic Partnerships
NEONC has also established several partnerships in key strategic areas that
support the company’s growth:
USC Stevens Institute for Innovation, Intellectual Property Licensing Partner
-- The intellectual property relating to the intranasal delivery of POH has
been assigned to the USC Stevens Institute for Innovation. A patent
application for treatment of cancer using monoterpenes/POH as a standalone
therapy and in conjunction with therapeutic agents, sub solvents and inhaler
pump, has been filed by USC Stevens and licensed to NEONC for the life of the
patent. NEONC has also licensed an existing patent from the Cancer Research
Center of the University of Wisconsin.
Kurve Technologies, Intranasal Delivery System Partner – NEONC has an
exclusive contract with Kurve Technologies, a manufacturer of inhalation
devices, to provide intranasal delivery of NEO100. Kurve has a versatile
device technology platform for the inhalational delivery of a wide range of
topical, systemic, and nose-to-brain medical therapies. This device
effectively disrupts inherent nasal cavity airflows to deliver formulations to
the entire nasal cavity, the olfactory region, and the par nasal sinuses. This
technology leads to more effective treatments compared to nasal spray bottles
that deliver formulations only as far as the anterior portion of the nasal
cavity. The licensing agreement with Kurve provides NEONC with ownership of
all intellectual property related to the chemical compounds that are
Drug Development Partnerships – NEONC is in discussions with the Norris
Comprehensive Cancer Center of USC to conduct clinical trials using NEO100 and
is seeking to form a drug development and commercialization partnership with a
major pharmaceutical company.
About NEONC Technologies
NEONC Technologies, Inc. is an early-stage biotechnology company focused on
developing new drugs using intranasal brain delivery. The Company’s lead
compound is NEO100, a novel, highly purified form of the monoterpene perillyl
alcohol under development for treatment of deadly brain disease known as
glioblastoma multiforme. NEONC has established a robust pipeline of over 80
POH derivatives and new compounds and has licensed existing patents and filed
several patent applications to build its patent portfolio. The Company has
received an orphan drug designation for NEO100 for the treatment of malignant
gliomas. Please visit the company’s website at www.neonctech.com.
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NEONC Technologies, Inc.
Eytan Lombroso, Vice-Chairman, Strategic Business Affairs
Patrick Walters, COO and CFO
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