LSK BIOPHARMA RECEIVES APPROVAL TO INITIATE PHASE 3 FROM KOREA’S MFDS, EXPECTS FIRST-PATIENT-ENROLLED IN GLOBAL PHASE 3 SHORTLY
SALT LAKE CITY, January 6, 2017 – LSK BioPharma (LSKB) today announced that it received approval for its apatinib phase 3 protocol under the Korean Ministry of Food and Drug Safety (MFDS). South Korea will be a part of the global phase 3 gastric cancer trial with 20 major centers including the ASAN Medical Center, Severance Hospital, Samsung Medical Center, Seoul National University Bundang Hospital, and the National Cancer Center. The global phase 3 trial, which is expected to enroll about 450 patients, is expected to enroll in 90 medical centers and 12 countries in Asia, North America, and Europe.
“We are happy with this milestone in our global phase 3 plan,” said Dr. Sung Chul Kim, President of LSKB, “We expect this pivotal study to be sufficient for market approval in 3rd line gastric cancer worldwide.”
The Company has already received advice from the US FDA, EMEA, and Japanese PMDA regarding the global phase 3 gastric cancer study and expects to quickly expand the trial globally utilizing Contract Research Organizations (CROs), LSK Global (LSKG), Chiltern, MPI, and Statplus. The Company expects Bukwang Pharm (the Korean license-holder of apatinib) to use the Global Phase 3 data for marketing approval in it’s territory.
Apatinib is the first successful small-molecule angiogenesis inhibitor in gastric cancer. It has been approved in China (advanced gastric cancer, Dec 2014) by the Chinese-territory license-holder Jiangsu Hengrui. LSK BioPharma, which holds the global rights (ex-China), has completed phase 1/2a clinical studies under a U.S. FDA IND and is planning to initiate multiple late stage clinical trials in gastric cancer (global pivotal trial), colorectal cancer, and hepatocellular carcinoma. LSKB has partnered development and marketing in Korea with Bukwang Pharma. Apatinib acts by inhibiting angiogenesis in solid tumors. Angiogenesis is a critical process in cancer growth and proliferation, as tumors cannot grow beyond 1-2mm3 without sufficient blood supply. Apatinib acts by selectively inhibiting VEGFR-2 which is primarily responsible for tumor-mediated angiogenesis. Apatinib has been tested in almost 1,000 patients worldwide and has demonstrated efficacy in numerous cancers including gastric cancer, colorectal cancer, HCC, NSCLC, breast cancer, mesothelioma, and neuroendocrine tumors.
About LSK BioPharma
LSKB is a privately-held biopharmaceutical company based in Salt Lake City, Utah. The Company specializes in the early clinical development of promising therapies for unmet medical needs in cancer. LSKB is developing two exciting drug candidates; a small molecule angiogenesis inhibitor with potential to treat a variety of solid tumors and a 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.