Pharma Focus Asia

Rafael Pharmaceuticals Announces Expansion into Austria, South Korea and Spain of Pivotal Phase 3 Trial of CPI-613 in Patients

Friday, August 02, 2019

Rafael Pharmaceuticals, Inc., a leader in the growing field of cancer metabolism-based therapeutics, today announced the expansion of its Phase 3 clinical trial (ARMADA 2000) of CPI-613® (devimistat) in patients with relapsed or refractory acute myeloid leukemia (AML) into Austria, South Korea and Spain. 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) in older patients with relapsed or refractory AML. The global study, currently in multiple U.S. sites, will open in three sites in Austria, several sites in South Korea and six sites in Spain.

“Every year, more than 30,000 people throughout Europe and 2,000 people in South Korea are diagnosed with AML, and their five-year survival rate is less than 30%, with worse outcomes for the elderly,” said Sanjeev Luther, President and CEO of Rafael Pharmaceuticals. “Our trial, which received orphan drug designation, offers hope to relapsed AML patients more than 60 years old. Our goal at Rafael has always been to help patients with significant unmet medical needs, and I am honored to bring that commitment overseas with these trials.”

Dr. Heinz Sill, hematologist at the University Hospital Graz, will be the lead investigator on the clinical trials in Austria.

“I am excited to help initiate the spread of devimistat globally,” said Dr. Sill. “There are currently limited therapeutic options for AML, and I look forward to helping to develop another option.”

Dr. Pau Montesinos, from the department of hematology at the University and Polytechnic Hospital of La Fe, will be the lead investigator on the clinical trials in Spain.

“After seeing the advancements of cancer metabolism in the United States, and the promising results from previous trials, I am hopeful this trial can continue making strides for AML patients as it expands into Europe,” said Dr. Montesinos.

“It is very encouraging the focus on cancer metabolism as an important element of cancer biology and a target of cancer therapy is being addressed by devimistat in this clinical trial for AML which is now expanding into Europe and other regions of the world,” said Dr. Jorge Cortes, deputy chair and professor of medicine in the department of leukemia at MD Anderson Cancer Center and principal investigator on the global trial. “I am optimistic that devimistat will help us improve the treatment for AML and ultimately the outcome of AML patients worldwide.”

Phase 3 clinical trials for devimistat are projected to open in other cities in Europe and other regions in the future.

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