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LSKB ANNOUNCES ENROLLMENT OF THE FIRST PATIENTS IN THE US AND EUROPE FOR ITS ONGOING APATINIB PHASE 3 CLINICAL TRIAL IN ADVANCE
SALT LAKE CITY, USA, December 20, 2017 — LSK BioPharma (LSKB, Company) has enrolled the first US and European patients in its ongoing, multinational Phase 3 ANGEL Study; a pivotal study assessing the safety and efficacy of apatinib in patients with advanced or metastatic gastric cancer. The Company has now opened sites in Asia, US, Europe, Eastern Europe, and Russia.
“We have enrolled over 1/3 of our total expected patients in the ANGEL study and are looking forward to accelerating overall enrollment with newly opened sites in the US, Europe, and Eastern Europe,” said Dr. Sung Chul Kim, President, “We believe the addition of gastric cancer patients outside of Asia is essential to the regulatory, clinical, and commercial success of apatinib globally.”
The multinational Phase 3 ANGEL study is expected to enroll 459 patients and will assess the safety and efficacy of apatinib vs. placebo in advanced or metastatic gastric patients who have failed two or three lines of therapy. The Phase 3 trial was designed with input from the US FDA, the PMDA (Japan), EMA (EU), TFDA (Taiwan), and MFDS (South Korea). LSKB believes apatinib can be approved based on this single pivotal Phase 3 clinical trial in 3rd and 4th line gastric cancer patients. More details about the study can be found on clinicaltrials.gov (NCT03042611).