Clinical Trial of Telomelysin in a Patient with Esophageal Cancer Started in Japan
December 06, 2013
A clinical trial to determine the safety and effectiveness of Telomelysin in combination with radiation therapy has started in ,Okayama University Hospital on November 29. 2013.
Telomelysin (OBP-301) is an adenovirus in which genes are modified to be able to selectively replicate in cancer cells and kill them, but not in normal cells. Telomelysin was developed and manufactured by Oncolys BioPharma Inc. A phase I clinical trial was conducted in the USA and demonstrated the safety and effectiveness of Telomelysin.
Telomelysin via intratumoral injection was administered to a patient with esophageal cancer who has mild renal dysfunction. Adverse events except a transient slight fever were not observed. Radiation therapy was started three days after administration of Telomelysin. The therapy regimen is 2 gray/day, 5 times a week and will continue until January 16, 2014. Two more administrations of Telomelysin will be planned.
The effectiveness of the treatment will be assessed endoscopically and pathologically after 3 months.
If the clinical study demonstrates safety and effectiveness, the combination with Telomelysin and radiation could be a great therapy for esophageal cancer or head and neck cancer patients with old age and complications.
This study is funded by the Ministry of Health, Labor and Welfare, Japan.
Mototaka Senda, Ph.D.
Intellectual Property Office, Organization for Research Promotion and Collaboration, Okayama University
Fremont, California USA
Toshiyoshi Fujiwara, MD
Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan