LSK BioPharma Announces Enrollment of First Patient in Phase 3 Apatinib Trial in Gastric Cancer
- Category: Small Molecules
- Published on Tuesday, 14 March 2017 09:53
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SALT LAKE CITY, UT, USA I March 13, 2017 I LSK BioPharma (LSKB, Company) announced today enrollment of the first patient in a global, multicenter phase 3 trial to evaluate apatinib in patients with advanced or metastatic gastric cancer.
This first patient was enrolled at ASAN Medical Center (AMC) in Seoul, South Korea. AMC recruited patients in an earlier trial of apatinib and is the first site to enroll patients in the phase 3 trial. The Company expects to open 95 sites in 12 countries including select European countries, the US, South Korea, Japan, and Taiwan.
"We are pleased to commence patient enrollment for our Apatinib trial in advanced or metastatic gastric cancer," said Dr. Sung Chul Kim, President, LSK BioPharma. "Achieving this milestone is an important step towards making apatinib available to cancer patients worldwide and demonstrates LSKB's long-term commitment to gastric cancer where we believe there is a significant clinical need."
About the Apatinib Phase 3 Trial
The 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), 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, it 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. LSK BioPharma, which holds the global rights (ex-China), has partnered development and marketing in Korea with Bukwang Pharma. The Company has completed phase 1/2a clinical studies under a U.S. FDA IND and has initiated a global phase 3 clinical trial in gastric cancer. LSKB is also planning to initiate a phase 2 trial in colorectal cancer (Korea and EU) followed closely by phase 2 development in hepatocellular carcinoma. 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.
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 VEGFR-2 inhibitor which has demonstrated clinical efficacy in 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.
SOURCE: LSK BioPharma