LSK BioPharma Announces Approval to Initiate a Phase 2 Clinical Trial in Colorectal Cancer in South Korea
SALT LAKE CITY, USA, May 8, 2017 – LSK BioPharma (LSKB, Company) announced today that it has received approval from the Korean Ministry of Food and Drug Safety (MFDS) to initiate a phase 2 clinical trial of apatinib, the Company’s proprietary angiogenesis inhibitor, in colorectal cancer. The Company is already conducting a global phase 3 clinical trial of apatinib in advanced gastric cancer, an indication for which the drug has already received market approval in China.
“We saw promising indications of efficacy in metastatic colorectal cancer patients in our phase 1/2a clinical study of apatinib,” noted Dr. Sung Chul Kim, President of LSK BioPharma, “We look forward to seeing the results of this phase 2 trial considering the exceptional tolerability profile that has been demonstrated and the clinical benefits for such a compound in metastatic colorectal cancer.”
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 metastatic colorectal cancer (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 ratio.
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).
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 Korea with Bukwang Pharma Co., Ltd. Apatinib has been clinically tested in over 1,000 patients worldwide and has demonstrated efficacy in numerous cancers including gastric cancer, colorectal cancer, 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 from the European Commission designating apatinib as an orphan medicinal product for the treatment of gastric cancer in the European Union as well as has the MFDS for South Korea.
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.