@article{f40e8d0e37264858b452cdb1eec73347,
title = "Study protocol of a Phase I/IIa clinical trial of Ad-SGE-REIC for treatment of recurrent malignant glioma",
abstract = "Malignant glioma is one of the most common brain cancers in humans, which is very devastating. The expression of reduced expression in immortalized cells/Dickkopf-3 (REIC/Dkk-3) is decreased in various human cancers. Lately, we have developed a novel second-generation adenoviral vector that expresses REIC/Dkk-3 (Ad-SGE-REIC) and revealed its antiglioma efficacy. The present investigator-initiated clinical trial is a single-arm, prospective, nonrandomized, noncomparative, open-label, single-center trial performed at Okayama University Hospital, Okayama, Japan. The primary end points are dose-limiting toxicities and the incidence of adverse events. The secondary end points are the objective response rate and immunological assessment. Use of Ad-SGE-REIC will help to improve the prognosis of patients with malignant brain tumors.",
keywords = "DKK3, gene therapy, malignant glioma, prognosis, safety",
author = "Kazuhiko Kurozumi and Kentaro Fujii and Yosuke Shimazu and Yusuke Tomita and Tatsuya Sasaki and Takao Yasuhara and Tomohito Hishikawa and Masahiro Kameda and Hiromi Kumon and Isao Date",
note = "Funding Information: This research is supported by AMED under grant number JP19lm0203095. Okayama University will receive cGMP-grade products of Ad-SGE-REIC from Momotaro-Gene Inc. to perform the present clinical trial. The current trial will be conducted by researchers in the Department of Neurosurgery, Okayama University Hospital. Our department receives research funding from Momotaro-Gene Co. Ltd., but this fact will not influence the trial results. Okayama University and Momotaro-Gene Inc., a start-up biotech company from Okayama University, hold the patents for the Ad-REIC agent. They are working together on the development of the Ad-REIC agent as a cancer therapeutic medicine. H Kumon is the Chief Scientific Officer of Momotaro-Gene Inc. He demonstrated the utility of the agent and also owns stocks in Momotaro-Gene Inc. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript. Publisher Copyright: {\textcopyright} 2020 Future Medicine Ltd.",
year = "2020",
doi = "10.2217/fon-2019-0743",
language = "English",
volume = "16",
pages = "151--159",
journal = "Future Oncology",
issn = "1479-6694",
publisher = "Future Medicine Ltd.",
number = "6",
}
