NEO 100 Human Trial In Adult Patients With Recurrent Glioblastoma

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 Fonseca^7,10, Thomas C Chen^6,7,11

A Phase 1 Human Trial of NEO 100 was conducted to study the therapeutics’ survivability impact and tolerance capacity. NEO 100, which is NeOnc Technologies 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 NEO 100 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 NEO 100 was well tolerated at all dose levels and no severe adverse events were reported. PFS-6 was 33%, OS-12 was 58%, and median OS was 15 months. Four patients (33%) survived more than 24 months.

As a result, NEO 100 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.

 

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