LSKB Announces that the ANGEL Study Has Reached its Primary Completion Date
SALT LAKE CITY, USA, Feb 12, 2019 — LSK BioPharma (LSKB, Company) announced that it has reached the pre-specified number of events required for unblinding and analysis of the primary endpoint of overall survival in the ANGEL study, a global Phase III clinical trial, which is evaluating the safety and efficacy of rivoceranib (also known as apatinib) in patients with advanced or metastatic gastric cancer.
“Reaching the primary completion date in our global pivotal trial is an important milestone in the development of rivoceranib” said Scott Houston, Vice President of Clinical Development, “Outside of China, where apatinib is marketed, there is no small-molecule angiogenesis inhibitor approved for gastric cancer. We believe it will be the first such drug available for these patients worldwide.”
The Company, which has conducted pre-submission meetings with FDA and EMA in the last month, will now focus on completion of database lock activities and subsequent data analysis with an expectation that the top-line, unblinded safety and efficacy data will be reported in the middle of this year. LSKB further expects to complete preparations in the second half of this year for filing marketing authorizations applications in several territories worldwide, including the US.
About Rivoceranib (Apatinib)
Rivoceranib is the first successful small-molecule angiogenesis inhibitor in gastric cancer. Rivoceranib acts by inhibiting angiogenesis, a critical process in cancer growth and proliferation. Specifically, rivoceranib 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 holds the global rights (ex-China). The Company is currently conducting a global (12 countries including US, Japan, Korea, Italy, Germany, and Russia) Phase 3 clinical trial of rivoceranib in advanced or metastatic gastric cancer patients. Rivoceranib 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 clinical outcomes in combination with chemotherapeutics and immunotherapy, as well as for maintenance therapy. LSKB has received notification designating rivoceranib as an orphan medicinal product for the treatment of gastric cancer from the European Commission in the European Union, the US FDA, as well as the MFDS in South Korea.
About LSK BioPharma
LSKB is a privately-held biopharmaceutical company with offices in Utah, California, and South Korea. The Company specializes in clinical development of promising targeted therapies for unmet medical needs in cancer. LSKB’s lead proprietary drug candidates is rivoceranib, a selective VEGFR-2 inhibitor which has demonstrated clinical efficacy in a variety of solid tumors. LSKB can be found on the web at www.lskbiopharma.com.