In something of a surprise move, Japan's NanoCarrier submitted a Phase I application to the Pharmaceuticals and Medical Devices Agency for oncology candidate NC-6004, Nanoplatin, on June 9.
In January, the company said that trials of Nanoplatin in Taiwan, Singapore, Hong Kong, Korea and Australia this year with Taiwan's Orient Europharma were progressing and they announced plans to build a new manufacturing plant in the Central Taiwan Science Park-Huwui Park.
Plans included FDA-approval for the plant. The Phase III study with Orient Europharma is for the treatment of locally advanced or metastatic pancreatic cancer.
NanoCarrier has previously said the candidate would be used in combination with gemcitabine outside Japan.
Elsewhere, it is independently conducting a Phase Ib/II study for non-small cell lung cancer in the U.S. and a Phase I study for solid tumors in Japan.
- here's the release (PDF)