Taiho Pharmaceutical Co., Ltd., a subsidiary of Otsuka Holdings Co., Ltd., has announced that the company will be initiating a global phase III clinical trial (RECOURSE) for the novel combination antimetabolite TAS-102 by June this year.

RECOURSE is a randomized, double-blind, placebo-controlled Phase III trial that compares TAS-102 with best supportive care (BSC) to investigate the efficacy and safety of TAS-102 when administered to patients with advanced recurrent colorectal cancer that is both unresectable and relapsed/refractory to standard chemotherapies. Standard chemotherapies include fluoropyrimidines, irinotecan, oxaliplatin, bevacizumab and, in the case of patients whose tumour harbors the wild-type KRAS gene, an anti-EGFR monoclonal antibody. The primary endpoint is overall survival. Eight hundred patients around the world will be enrolled into the trial, beginning in Japan in June, followed by North America, Europe, and Australia. The principal investigators will be Dr Atsushi Ohtsu, National Cancer Centre Hospital East (Kashiwa/Japan), Dr Robert J Mayer, Dana Farber Cancer Institute (Boston/USA), and Dr Eric Van Cutsem University Hospital Gasthuisberg (Leuven/Belgium).

Taiho Pharmaceutical is proceeding with the global development of TAS-102 so that this drug can be offered as soon as possible to metastatic colorectal cancer patients who have exhausted standard treatment options.

TAS-102 combines: FTD (a,a,a-trifluorothymidine), a nucleoside analog which disrupts a variety of DNA functions necessary for the proliferation of cancer cells by being efficiently incorporated into DNA, and 5-chloro-6-(2-iminopyrrolidin-1-yl)-methyl-2, 4(1H, 3H)-pyrimidinedione hydrochloride (TPI), which maintains an effective blood concentration of FTD by inhibiting thymidine phosphorylase which is the primary enzyme involved in the degradation of FTD.

Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co., Ltd., is an R&D-driven specialty pharma focusing on the three fields of oncology, allergies and immunology, and urology.

The Otsuka Group is a diversified healthcare group operating globally under the corporate philosophy ‘‘Otsuka-people creating new products for better health worldwide’’.