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TMCNet:  NEONC Technologies Scientific and Clinical Advisory Board Plans Development and Clinical Testing of NEO100 in Treatment of Gliomas and Other Cancers

[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 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 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 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 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 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 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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