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D. Bradley Welling, Department of Otolaryngology Head and Neck Surgery, Harvard Medical School, Massachusetts Eye and Ear and Massachusetts General Hospital, 243 Charles Street, Boston, MA 20114, USA. Email: brad_welling@meei.harvard.edu
Conceived the study: D. Bradley Welling, Amir Mortazavi, Craig C. Hofmeister. Performed experiments: Long‐Sheng Chang, Janet L. Oblinger, Sarah S. Burns. Provided patient care: D. Bradley Welling, S. Alireza Mansouri, Brian A. Neff, Janet L. Oblinger, Robert K. Jackler, Amir Mortazavi. Analyzed the data: D. Bradley Welling, Katharine A. Collier, Beth A. Miles‐Markley, Mina S. Makary, H. Wayne Slone. Prepared the manuscript: D. Bradley Welling, Katharine A. Collier, Long‐Sheng Chang, Amir Mortazavi, Edina Shu. Supervised project: D. Bradley Welling, Amir Mortazavi, Long‐Sheng Chang. All authors contributed to and approved the manuscript.
The authors thank our patients who participated. We also thank the OSUCCC PhASR core for PK analysis. We express appreciation to Edwin M. Choy, MD, PhD, Dominic J. Reda, PhD, and Christopher Moertel, MD, our Data Safety & Monitoring Board; Christine Finn, PharmD consultant; and Arno Therapeutics. This work was supported by the U.S. Department of Defense (W81XWH‐14‐1‐0167 to D. Bradley Welling, W81XWH‐18‐1‐0547 to Long‐Sheng Chang); National Cancer Institute of the National Institutes of Health (U01CA076576, R01CA201382 to Amir Mortazavi and Craig C. Hofmeister); the Galloway Family; Advocure NF2; The Ohio State University Comprehensive Cancer Center (P30CA16058); and The Ohio State University Center for Clinical and Translational Science to Long‐Sheng Chang. The content is solely the responsibility of the authors and does not represent official views of the sponsors.
D. Bradley Welling is a consultant for CereXis, Science 24/7, NFBio, NF2 Biosolutions, and Mulberry Bio. Craig C. Hofmeister has received research grants from Takeda and Oncolytics Biotech; research and personal grants from Janssen, BMS, Sanofi, Nektar, Karyopharm, Imbrium, and Oncopeptides, all outside the submitted work. Amir Mortazavi is on the advisory board for Seattle Genetics and Pfizer and is on the scientific advisory board for Debiopharm Group. His institution (but not him) has received research funding from Acerta Pharma, Genentech, Roche, Merck, Novartis, Seattle Genetics, Astellas Pharma, Mirati Therapeutics, and Bristol‐Myers Squibb. The other authors declare no potential conflict of interest. The Ohio State University (OSU) holds the patent on the investigational drug AR‐42 (US 10/597022). The Technology Commercialization Office has licensed AR‐42 (now called REC‐2282) to Recursion Pharmaceuticals using the institution's standard terms, conditions, and approval process, in which no author participated. To assure absence of institutional conflict of interest in assessment of response and attribution of toxicity, both were reviewed by the Cancer Therapy Evaluation Program of the National Cancer Institute prior to reporting results for the phase I study. Safety issues related to dose increases and attribution of response were monitored by The OSU Data Safety Monitoring Committee and The OSU Cancer Center Institutional Review Board for the phase 1 pilot. A separate Data Safety and Monitoring Board of Massachusetts Eye and Ear oversaw pilot study 2.
© 2021 The Authors. Laryngoscope Investigative Otolaryngology published by Wiley Periodicals LLC on behalf of The Triological Society.