US based Rafael Pharmaceuticals, Inc., a leader in the growing field of cancer metabolism-based therapeutics, has announced that the Phase 3 clinical trial (ARMADA 2000) of CPI-613® (devimistat) in older patients with relapsed or refractory acute myeloid leukemia (AML) is now active and enrolling patients in South Korea.

The multicenter, open-label, randomized pivotal trial is evaluating the efficacy and safety of its lead compound devimistat in combination with high dose cytarabine and mitoxantrone (CHAM). The clinical trials kicked off with an investigator meeting held on Sept. 19 in Seoul.

“Bringing our Phase 3 clinical trials for patients with AML to South Korea will mark the first of Rafael’s devimistat trials in Asia, with additional trials in the region planned for patients with pancreatic cancer in the near future,” said Sanjeev Luther, President and CEO of Rafael Pharmaceuticals. “This expansion is part of our larger goal to treat patients with unmet clinical needs around the world.” 

The study, currently in multiple U.S. and European sites, will now expand to the following four sites in South Korea: Asan Medical Center, Samsung Medical Center, Seoul National University Hospital and Severance Hospital. Lead investigators include Dr. Eun-Ji Choi, Dr. Jun Ho Jang, Dr. Sung-Soo Yoon and Dr. June-Won Cheong.

“The opening of clinical trials in South Korea is imperative for treating elderly patients with refractory AML in the region, as they have a lower survival rate,” said Dr. Jorge Cortes, principal investigator on the global trial. “I have hopes for the success of devimistat in treating patients.”