ABSTRACT: A 63-year-old man with metastatic castration-resistant prostate cancer (CRPC) was successfully treated for two years with in situ gene therapy using an adenovirus vector carrying the human REIC/Dkk‑3 gene (Ad-REIC), following chemotherapy. Ad-REIC mediates simultaneous induction of cancer-selective apoptosis and augmentation of antitumor immunity, and a Phase I/IIa clinical study on Ad-REIC has been conducted at Okayama University Hospital since January 2011. At the time of enrollment in December 2012, the patient presented with rapid progression of lymph node (LN) metastases. Two scheduled Ad-REIC injections and 10 additional Ad-REIC injections into metastatic pelvic and para-aortic LNs under CT guidance, with an average four weeks’ interval, exhibited the potent direct and indirect effects of Ad-REIC as a therapeutic cancer vaccine. During the next 12 months, three additional injections into para-aortic LNs showing regrowth achieved adequate control of all metastatic LNs with prostate-specific antigen (PSA) decline, without any particular adverse events.

KEYWORDS: REIC/Dkk-3 gene, cancer gene therapy, cancer vaccine, metastatic castrate-resistant prostate cancer

CITATION: Kumon et al. Ad-REIC Gene Therapy: Promising Results in a Patient with Metastatic CRPC Following Chemotherapy. Clinical Medicine Insights: Oncology 2015:9 31–38 doi: 10.4137/CMO.S23252.

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RECEIVED: January 12, 2015. RESUBMITTED: February 12, 2015. ACCEPTED FOR PUBLICATION: February 14, 2015.

ACADEMIC EDITOR: William C. S. Cho, Editor in Chief

TYPE: Case Report

FUNDING: This research was funded by a grant-in-aid for the “Creation of Innovation Centers for Advanced Interdisciplinary Research Areas”, a research project of the Ministry of Education, Culture, Sports, Science and Technology (MEXT) of Japan, and by a Health and Labour Sciences Research Grant from the Ministry of Health, Labour and Welfare of Japan. Okayama University received research funds for joint research in cooperation with Momotaro-Gene Inc. The authors confirm that the funders had no influence over the study design, content of the article, or selection of this journal.

COMPETING INTERESTS: Momotaro-Gene Inc. holds the patents of the Ad-REIC agent and develops the agent as a cancer therapeutic medicine. HK, MW, and YN demonstrated the utility of the agent and also own stocks in Momotaro-Gene Inc. HK is the Chief Scientific Officer of Momotaro-Gene Inc. Okayama University and Momotaro-Gene Inc. are working together on the development of the Ad-REIC agent. Okayama University received the GMP-grade Ad-REIC agent from Momotaro-Gene Inc. to perform clinical trials for the treatment of cancer patients. Outside the submitted work, HK, YN, MW, SK, TH, SE, YA and KS report grants from MEXT of Japan. HK, YN, MW, SK, TH report grants from the Ministry of Health, Labour and Welfare of Japan. HK, YN and MW report grants from the Japan Science and Technology Agency. HK, YN and MW, as indicated following the patent numbers, disclose the following patents, all licensed to Momotaro-Gene Inc: WO 2001/038528 (HK), WO 2006/098074 (HK, YN), WO 2009/060982 (HK, YN, MW), WO 2009/119874 (HK, YN, MW), WO 2010/013846 (HK, YN, MW), WO 2011/062298 (HK, YN, MW), WO 2012/161352 (HK, YN, MW).

CORRESPONDENCE: [email protected]

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