Rafael Pharmaceuticals Expands Phase 2 CPI-613 Trial

Rafael Pharmaceuticals, a division of Rafael Holdings (NYSE:RFL) has announced that its Phase 2 clinical trial of CPI-613 for patients with relapsed or refractory Burkitt’s lymphoma/leukemia has been expanded.

As quoted in the press release:

The clinical trial will begin enrolling patients at Massachusetts General Hospital in Boston starting this month. The trial is currently underway at Memorial Sloan Kettering Cancer Center in New York City and at City of Hope in Duarte, California.

“Burkitt’s lymphoma is a rare disease, with approximately 1,200 people in the United States diagnosed annually, so treatment options for these patients are very limited,” said Sanjeev Luther, President and CEO of Rafael Pharmaceuticals. “The disease is highly aggressive and has a high rate of relapse. Expanding our clinical trial will increase access and create hope for patients and their loved ones across the country.”

In June 2018, devimistat received orphan drug designation for the treatment of relapsed Burkitt’s lymphoma from the U.S. Food and Drug Administration (FDA). Orphan drug designation refers to a special status granted by The Orphan Drug Act (ODA) to a drug used to treat a rare disease or condition.

“Currently no definitive second-line therapy exists for patients with relapsed Burkitt’s lymphoma,” said Ariela Noy, M.D., an oncologist at Memorial Sloan Kettering Cancer Center and principal investigator on the devimistat clinical trial for relapsed Burkitt’s lymphoma. “The expansion of the clinical trial across the country will help reach patients that have a clear unmet medical need for additional treatment options.”

Click here to read the full press release.