LSK BioPharma Announces Starting of Site Initiation Visits in the U.S. for its Phase 3 Gastric Cancer Trial Studying Apatinib
SALT LAKE CITY, USA, May 16, 2017 – LSK BioPharma (LSKB, Company) announced today that it has started Site Initiation Visits (SIVs) for clinical sites in the United States for its global apatinib phase 3 gastric cancer trial. The Company has already initiated sites in South Korea, Japan, and Taiwan, and is currently enrolling patients. LSKB expects to open sites in a total of 12 countries in Asia, North America, and Europe over the next several months.
“We are excited to bring this important trial to the US,” noted Dr. Sung Chul Kim, President of LSK BioPharma, “Although the clinical need for apatinib in gastric cancer is well known in Asia, we believe the drug will bring an important benefit to such patients in the US and Europe.”
The SIV is the last important step wherein the Company and CRO confirm that the site is prepared to start enrolling patients in the clinical trial.
About the Apatinib Phase 3 Trial
The ongoing apatinib global phase 3 trial, which is expected to enroll about 459 patients, is designed to assess the efficacy of apatinib plus best supportive care vs. placebo with best supportive care 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 that with positive overall survival results, the drug will be approved based on this single pivotal Phase 3 clinical trial for the treatment of 3rd and 4th line gastric cancer patients. More details about the study can be found on clinicaltrials.gov (NCT03042611).
About the Apatinib Phase 2 Trial
The phase 2 trial follows on the positive early indication of efficacy of apatinib in metastatic colorectal cancer (mCRC) that was observed in LSKB’s phase 1/2a study. The phase 2 trial will be conducted in patients with mCRC who have failed approved standard therapies. The trial is a multinational, randomized, double-blind, placebo-controlled study which will enroll approximately 117 subjects in a 2:1 (apatinib : placebo) ratio.
Apatinib is the first successful small-molecule angiogenesis inhibitor in gastric cancer. Apatinib acts by inhibiting angiogenesis, a critical process in cancer growth and proliferation. Specifically, apatinib selectively inhibits VEGFR-2 which mediates the primary pathway for tumor-mediated angiogenesis. It was approved in China (advanced gastric cancer, Dec 2014) where it is marketed by the Chinese-territory license-holder Jiangsu Hengrui Medicine Co., Ltd. LSK BioPharma, which holds the global rights (ex-China), has partnered development and marketing in South Korea with Bukwang Pharmaceutical Co., Ltd. Apatinib has been clinically tested in over 1,000 patients worldwide and has demonstrated efficacy in numerous cancers including gastric cancer, CRC, HCC, NSCLC, esophageal cancer, thyroid cancer, mesothelioma, and neuroendocrine tumors. It has also shown potential to significantly improve outcomes in combination with chemotherapeutics and immunotherapy, as well as for maintenance therapy. LSKB has received notification designating apatinib as an orphan medicinal product for the treatment of gastric cancer from the European Commission in the European Union as well as the MFDS in South Korea. The Company has submitted for orphan designation in the U.S.
About LSK BioPharma
LSKB is a privately-held biopharmaceutical company based in Salt Lake City, Utah. The Company specializes in clinical development of promising therapies for unmet medical needs in cancer. LSKB is developing two proprietary drug candidates; apatinib, a selective VEGFR-2 inhibitor which has demonstrated clinical efficacy in a variety of solid tumors and a selective BTK/JAK3 inhibitor with the potential to treat hematologic malignancies and rheumatoid arthritis as an immunosuppressive agent. LSKB can be found on the web at www.lskbiopharma.com.