LSK BioPharma’s Apatinib Receives Orphan Drug Designation in the European Union
SALT LAKE CITY, USA, March 1, 2017 – LSK BioPharma (LSKB, Company) today announced that it has received notification that the European Commission has designated apatinib as an orphan medicinal product for the treatment of gastric cancer in the European Union. Further to the development of apatinib in this indication, the Company announced that it has started site-initiation-visit (SIV) meetings for its global phase 3 clinical trial in 3rd line gastric cancer.
Orphan Drug Designation can be awarded when the sponsor establishes that the medicinal product will be of significant clinical benefit to the intended orphan population. There are a number of incentives companies may receive when awarded this designation, including protocol assistance, scientific advice, and market exclusivity above and beyond patent expiration. Regulatory fee reductions are also available. Medicines identified under Orphan Drug Designation are also reviewed under a centralized authorization procedure. This procedure allows for the submission of a single marketing-authorization application to European Medicines Agency (EMA) that, if approved, will make apatinib available throughout the EU.
“The Orphan Drug Designation for apatinib in the European Union is a key regulatory milestone in the road to market approval,” said Dr. Sung Chul Kim, President, “We strongly believe apatinib will provide a much-needed therapy to gastric cancer patients worldwide and this designation will help to streamline and accelerate the development process.”
The Company further announced that it has completed the SIV meeting on the initial trial site in Korea for the global phase 3 clinical trial in 3rd line gastric cancer. The company expects to enroll 459 patients at 95 sites in 12 countries with the first patients to be treated in short order.
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 is initiating 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.
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.