Clinical trial of aptamer-based liver cancer drug to begin at 4 Korean hospitals

Clinical trials of AST-201, a new liver cancer drug with an aptamer-based drug delivery platform, Aptamer-Drug Conjugate (ApDC) technology, will likely begin soon at four medical institutions in Korea.

ApDC technology uses aptamers instead of antibodies as target delivery agents. It is attracting attention as a next-generation technology field because it delivers drugs to target cancer cells with high efficiency, reduces side effects, and has advantages in drug manufacturing.

Aptamer Sciences said Wednesday that it held an investigator meeting (IM) with principal investigators from four institutions – CHA University Bundang Medical Center, National Cancer Center, Samsung Medical Center, and Severance Hospital -- for the phase 1 clinical trial of AST-201.

At the meeting, clinical trial leaders from each medical institution participated in a detailed review of the protocol, patient recruitment methods, and follow-up schedule, discussing how to conduct a smooth and efficient clinical trial.

“There are a total of four sites conducting the phase 1 clinical trial of AST-201 for liver cancer, which will evaluate the safety and tolerability of AST-201 in up to 36 patients with GPC3-positive advanced solid tumors,” Aptamer Sciences said. “Even though it is a phase 1 clinical trial, we expect to conduct efficacy exploration as an adjunct to the trial to obtain valid data for technology transfer.”

CBO Lee Kwang-yong, head of the Bio Business Unit at Aptamer Sciences, said, “All steps to initiate the clinical trial are on track, and we expect the first dose of AST-201 to be administered next January after recruiting eligible patients. We aim to have data for both dose groups in the first half of next year.”