Enrollment Begins in Devimistat Trial for Patients With Relapsed Clear Cell Sarcoma


The first patient has been enrolled in the APOLLO 613 Phase 1/2 clinical trial for CPI-613.

Rafael Pharmaceuticals announced the enrollment of a first patient in its APOLLO 613 phase 1/2 clinical trial. The trial will examine CPI-613 (devimistat) in combination with hydroxychloroquine to treat patients with clear cell sarcoma, a rare type of sarcoma making up just 1% of sarcoma cases.

Enrollment is open for patients at City of Hope in Duarte, California as well as Cleveland Clinic Children’s and University of Michigan’s Rogel Cancer Center.

“Clear cell sarcoma has the propensity to spread quickly within the body, and our current available medical therapies are not consistently beneficial to patients,” said Dr. Rashmi Chugh, co-principal investigator from the University of Michigan, in a release. “Finding effective treatments for the disease is critical, and we are hopeful that devimistat’s mechanism of action will be effective in clear cell sarcoma patients.”

CPI-613 targets the enzymes involved in cancer cell energy metabolism. It was designated by the Food and Drug Administration (FDA) as an orphan drug for the treatment of pancreatic cancer, acute myeloid leukemia, myelodysplastic syndrome, peripheral T-cell lymphoma, soft tissue sarcoma, Burkitt’s lymphoma and biliary tract cancer.

“Enrolling a patient so soon after we opened the trial demonstrates the dire need for a treatment and the hope that devimistat brings to the rare cancer community,” said Sanjeev Luther, President and CEO of Rafael Pharmaceuticals, in a release. “We opened two additional sites in order to increase access to the trial for patients in need.”

The average age of diagnosis for patients with clear cell sarcoma is 25, and it is often not found until after it is already in advanced stages. Tumors typically occur in the arms, legs, feet and hands, though it can grow throughout the torso, according to the National Cancer Institute.

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