LSKB Announces Enrollment of the First Patients in the US and Europe for its Ongoing Apatinib Phase 3 Clinical Trial in Advanced or Metastatic Gastric Cancer
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).
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. The Company is currently conducting a global (12 countries including US, Japan, Korea, Italy, Germany, and Russia) Phase 3 clinical trial of apatinib in advanced or metastatic gastric cancer patients. 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, the US FDA, as well as the MFDS in 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 targeted 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 (designated LSK9985) 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.
Contact: Angie Price firstname.lastname@example.org