A Phase 1 Human Trial of NEO100 was conducted to study the therapeutics’ survivability impact and tolerance capacity. NEO100, which is NeOnc Technology Holdings’ core formulation of highly purified Peryllil Alcohol (POH), has been shown to be a highly effective transport mechanism for delivering therapeutics to the brain for the treatment of diseases such as brain-based glioblastomas.
In the study, a total of 12 patients with recurrent GBM were enrolled and administered NEO100 by intranasal delivery using a nebulizer and nasal mask. Patients were divided into four groups and each group was given a specific dosage for a 28-day period. Dosages were 96 mg/dose (384 mg/day) for Group 1, 144 mg/dose (576 mg/day) for Group 2, 192 mg/dose (768 mg/day) for Group 3, and 288 mg/dose (1152 mg/day) for Group 4.
Results of the study showed that Intranasal NEO100 was well tolerated at all dose levels and no severe adverse events were reported. PFS-6 was 33%, OS-12 was 58%, and the median OS was 15 months. Four patients (33%) survived more than 24 months.
As a result, NEO100 continues to demonstrate its ability to provide improved survivability when compared to historical controls and continues to point to the possibility that this novel intranasal approach could become useful for the treatment of recurrent GBM.
Read The Paper
Phase 1 Trial Of Intranasal Neo 100, Highly Purified Perillyl Alcohol, In Adult Patients With Recurrent Glioblastoma.
Authors: Axel Schonthal, PhD 1, David M Peereboom3, Naveed Wagle4, Rose Lai5, Anna J Mathew6, Kyle M Hurth6, Vincent F Simmon7, Steven P Howard8, Lynne P Taylor9, Frances Chow5, Clovis Orlando da Fonseca7,10, Thomas C Chen6,7,11
1 Department of Molecular Microbiology & Immunology, University of Southern California, Los Angeles, CA, United States, 2Department of Neurosurgery, University of Southern California, Los Angeles, CA, United States, 3Department of Medical Oncology, Cleveland Clinic, Cleveland, Ohio, 4Department of Oncology, Providence St. Johns Medical Center, Santa Monica, California, 5Department of Neurology, Keck School of Medicine, University of Southern California, Los Angeles, California, 6Department of Pathology, Keck School of Medicine, University of Southern California, Los Angeles, California, 7NeOnc Technologies, Inc., Los Angeles, California, 8Department of Radiation Oncology, University of Wisconsin, Madison, Wisconsin, 9Department of Medicine, University of Washington, Seattle, Washington 10Department of General and Specialized Surgery, Antonio Pedro University Hospital, Fluminense Federal University, Niterói, Rio de Janeiro, Brazil, 11Department of Neurological Surgery, Keck School of Medicine, University of Southern, California, Los Angeles, California
