A phase Ib/II clinical trial of the experimental anti-mitochondrial drug devimistat in combination with cisplatin and gemcitabine has been initiated in patients with biliary tract cancer, according to a press release from Rafael Pharmaceuticals, Inc. The company will collaborate with Michigan Medicine to proceed with the randomized multicenter clinical trial.
A phase Ib/II clinical trial of the experimental anti-mitochondrial drug devimistat (CPI-613) in combination with cisplatin and gemcitabine has been initiated in patients with biliary tract cancer, according to a press release from Rafael Pharmaceuticals, Inc. The company will collaborate with Michigan Medicine to proceed with the randomized multicenter clinical trial.
“Devimistat has demonstrated promising results in pancreatic cancer,” Vaibhav Sahai, MBBS, MS, principal investigator of the study and associate professor of medical oncology at Michigan Medicine, said in a press release. “Rare cancers require dedicated and innovative research, and I am hopeful that we will advanced treatment options for patients with biliary tract cancer.”
The phase Ib portion of the trial will determine a maximum tolerated dose of devimistat in combination with gemcitabine and cisplatin. This will lead to a recommended dose to be used in the phase II portion of the trial, in which investigators will determine the efficacy of the triplet regimen compared with combination chemotherapy alone. Investigators plan to enroll 68 to 72 patients in the study.
Devimistat is a first-in-class lead compound targeting enzymes involved with energy metabolism in cancer cells; metabolism takes place in the mitochondria. The agent is designed to target the mitochondrial tricarboxylic acid cycle, which is essential for tumor cell multiplication and survival. It also increases sensitivity of cancer cells to chemotherapeutic agents and allows for lower doses of toxic therapies to be administered when used in combination.
The FDA has previously granted approval for the company to initiatethe pivotal phase III study, AVENGER 500, for frontline devimistat in patients with metastatic pancreatic cancer, which is evaluating the drug in combination with a modified FOLFIRINOX regimen. The FDA also approved initiation of the phase III ARMADA 2000 trial (NCT03504410) to evaluate devimistat in patients with acute myeloid leukemia.
The open-label, multicenter, single-arm phase II ARMADA trial (NCT03793140) is also assessing responses with devimistat, which is evaluating patients with relapsed/refractory Burkitt’s lymphoma/leukemia.The ARMADA trial recently expanded in December 2019to include patients from Massachusetts General Hospital in Boston, MA, along with the patients being treated at Memorial Sloan Kettering Cancer Center in New York, NY, and the City of Hope in Duarte, CA.
“Biliary tract cancer is a rare and aggressive cancer that affects approximately 15,000 people in the United States each year,” Sanjeev Luther, president and CEO of Rafael Pharmaceuticals, said in a statement. “L
Rafael Pharmaceuticals Announces the Initiation of a Phase 1b/2 Clinical Trial of CPI-613 (devimistat) in combination with Gemcitabine and Cisplatin in Patients with Biliary Tract Cancer [news release]. Cranbury, NJ: Rafael Pharmaceuticals, Inc; January 21, 2020. https://yhoo.it/2Gkuo3P. Accessed January 23, 2020.