Daehwa Pharmaceuticals said that it has launched phase 2/3 clinical trials for Liporaxel, the world's first oral paclitaxel product for relapsed or metastatic breast cancer.
The announcement came after the company enrolled its first patient in the optimal study trial on Monday. The company plans to follow up the optimal study trial with 34 patients participating in phase 2 clinical trials at eight institutions in Korea, and 476 patients participating in phase 3 trials.
The clinical trials will evaluate the efficacy and safety of Liporaxel as a first-line therapy in patients with relapsed or metastatic breast cancer.
Paclitaxel, which is the main ingredient of the drug, is a common cytotoxic anticancer drug. It has been difficult to develop oral formulations due to problems such as absorption inhibition. However, the company successfully developed the oral formulation through its patented “DH-LASED platform” technology and obtained sales rights for stomach cancer last year.
“Paclitaxel is known to have greater efficacy in breast and ovarian cancer," a company official said. "The company expects that more patients will benefit if the efficacy and safety of this drug are demonstrated as a first-line therapy for breast cancer,” a company official said.
The company is also preparing smoothly for the OPERA study, a phase 2 clinical trial to be conducted in the U.S., he added.
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