TOKYO, July 22, 2011 /PRNewswire/ — Taiho Pharmaceutical Co.,
Ltd. (HQ: Tokyo, President: Toru Usami) announced on July 22 the
results of a randomized, Phase II clinical trial for the novel oral
nucleoside antitumor agent TAS-102 under development by the company
for metastatic colorectal cancer, at the 9th Annual Meeting of the
Japanese Society of Medical Oncology held in Yokohama. (Abstract
no. 10428)
The trial was a randomized, double-blind, placebo-controlled
study with a primary outcome measure of overall survival involving
172 patients with refractory metastatic colorectal cancer who had
received standard chemotherapy at least two or more regimens
containing a fluoropyrimidine, irinotecan, and oxaliplatin. The
results indicated that the TAS-102 significantly improved overall
survival compared with the placebo (overall survival median: 9.0
months vs. 6.6 months) and significantly reduced the risk of
mortality (HR=0.56, p=0.0011). Also, no instances of
treatment-related mortality were reported. The most frequently
reported adverse drug reaction with a CTCAE grade 3 or higher was
neutropenia. Grade 3 or higher diarrhea, fatigue, nausea, and other
adverse reactions were no more than 10%.
In light of these results, Taiho Pharmaceutical will proceed
with global development of TAS-102 so that this drug can be offered
as soon as possible to metastatic colorectal cancer patients who
have exhausted proven treatment options and there remains a high
unmet medical need.
About TAS-102:
TAS-102 is a novel oral nucleoside antitumor agent with a novel
mechanism of action, composed of a mixture of Trifluorothymidine
(FTD), which demonstrates antitumor effects through incorporation
into DNA, and
5-chloro-6-(2-iminopyrrolidin-1-yl)-methyl-2,4(1H,3H)-pyrimidinedione
hydrochloride (TPI), which inhibits the degradation of FTD. Phase I
trials began in Japan in 2005, and the drug continues to be
developed as a treatment for colorectal cancer refra
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