|[February 07, 2013]
NEONC Technologies Scientific and Clinical Advisory Board Plans Development and Clinical Testing of NEO100 in Treatment of Gliomas and Other Cancers
LOS ANGELES --(Business Wire)--
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 neuro-oncology.
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 Wisconsin.
Dr. Marc Chamberlain, MD -- Professor of Neurology, University of
Washington, a world renowned neuro-oncologist, well known for his
work on leptomeningeal carcinomatosis.
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 ttorney and
partner of Axinn,Veltrop. He is the key advisor for NEONC's patent
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 development.
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
Dr. Michael Gould, PhD -- Professor of Medicine, University of
Wisconsin, was the investigator who initiated studies of POH as an
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
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 tumors.
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 (News - Alert). 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
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 School.
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 delivered.
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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