Cranbury, NJ, Oct. 28, 2019 (GLOBE NEWSWIRE) -- Rafael Pharmaceuticals, Inc. (“Rafael” or the “Company”), a leader in the growing field of cancer metabolism-based therapeutics, today announced the milestone activation of 25 sites for its pivotal Phase 3 clinical trial (ARMADA 2000) of CPI-613® (devimistat) in patients with relapsed or refractory acute myeloid leukemia (AML). 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 is now active at sites in the United States, Austria, Spain and South Korea, with more openings to come.
“The average age of diagnosis for AML is 68 years old, and the majority of patients will pass away within five years of this diagnosis,” said Sanjeev Luther, President and CEO of Rafael Pharmaceuticals. “We want to offer hope to patients with relapsed AML, and are proud to continue this commitment by activating 25 trial sites across the United States, as well as parts of Europe and Asia.”
Dr. Jorge Cortes, Director of the Georgia Cancer Center at Augusta University, is the principal investigator on Rafael’s Phase 3 clinical trial for patients with refractory AML. Dr. Cortes developed the rationale and design of the trial, and supervises the conduct of the ongoing clinical investigation.
“Activating 25 trial sites is a landmark achievement for this clinical trial that shows the strong interest in this approach among investigators,” said Dr. Cortes. “Relapsed or refractory AML remains a significant challenge for older patients, and I am hopeful that this clinical trial will expand the treatment options for AML patients across the globe.”
The trial will continue to open globally at additional site locations across the United States and other regions. The milestone number of sites takes the trial one step closer to the first interim data analysis and determining the efficacy of devimistat for patients with relapsed or refractory AML.
About CPI-613® (devimistat)
CPI-613® (devimistat) is a first-in-class clinical lead compound of Rafael, which targets enzymes that are involved in cancer cell energy metabolism and are located in the mitochondria of cancer cells. Devimistat is designed to target the mitochondrial tricarboxylic acid (TCA) cycle, a process essential to tumor cell multiplication and survival, selectively in cancer cells. Devimistat substantially increases the sensitivity of cancer cells to a diverse range of chemotherapeutic agents. This synergy allows for potential combinations of devimistat with lower doses of these generally toxic drugs to be more effective with lower patient’s side effects. Combination with devimistat represent a diverse range of opportunities to substantially improve patient’s benefit in many different cancers. The U.S. Food and Drug Administration (FDA) has given Rafael approval to initiate pivotal Phase 3 clinical trials in pancreatic cancer (AVENGER 500) and acute myeloid leukemia (ARMADA 2000), and has designated devimistat as an orphan drug for the treatment of pancreatic cancer, acute myeloid leukemia, myelodysplastic syndrome, peripheral T-cell lymphoma and Burkitt’s lymphoma. The EMA has granted orphan drug designation to devimistat for pancreatic cancer and acute myeloid leukemia.
About Rafael Pharmaceuticals, Inc.
Rafael Pharmaceuticals is a leader in the growing field of cancer metabolism. The company is developing a new, first-in-class category of metabolic oncology therapeutics that attack hard-to-treat cancers by targeting the metabolic processes the disease needs to survive, grow and proliferate. Rafael Pharmaceuticals’ lead compound, CPI-613® (devimistat), is a highly selective, well-tolerated and effective anti-cancer agent that is being evaluated in ongoing and completed Phase 1, 2 and 3 clinical trials. Devimistat has been granted orphan drug status by the FDA for the treatment of pancreatic cancer, acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and Burkitt’s and peripheral T-cell lymphomas. The Company's investors include Rafael Holdings, Inc. (NYSE AMERICAN: RFL). For more information, please visit www.rafaelpharma.com.
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