Delta-Fly Pharma (TYO:4598) said it will begin a phase 2/3 trial for DFP-17729 combined with TS-1 in patients with advanced pancreatic cancer after receiving approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA), according to a Monday filing on the Tokyo Stock Exchange.
The study, to be conducted at 15 clinical sites in Japan, will measure overall survival as the primary endpoint. If DFP-17729 with TS-1 shows superior efficacy to TS-1 alone, the drug could receive new drug approval from the PMDA.
TS-1, developed by Taiho Pharmaceutical, is used to treat several cancers, including pancreatic cancer.
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