Curis Says FDS Allows Additional Patient Enrollment For TakeAim Leukemia Study

(RTTNews) - Curis, Inc. (CRIS), a biotechnology firm focused on cancer treatment, said on Tuesday that the U.S. Food and Drug Administration or FDA has notified that it may resume additional patients' enrollment for the monotherapy phase of the TakeAim Leukemia study.

The TakeAim Leukemia study is a Phase 1/2 open-label dose escalation, dose expansion clinical trial investigating Emavusertib as a monotherapy and in combination with azacitidine or venetoclax in patients with relapsed or refractory (R/R) AML or high risk MDS.

The move follows the review of the additional data submitted by the drug maker.

The regulator has notified Curis that it may resume enrollment of additional patients in the monotherapy dose finding phase of the study, in which the company has agreed to enroll at least nine additional patients at the 200mg dose level.

However, the partial hold remains in place for the combination therapy phase and the expansion phase of the TakeAim Leukemia study until Phase 1a is complete, and the FDA approves proceeding to the next phases of the study.

FDA had placed partial clinical holds on the TakeAim Leukemia and TakeAim Lymphoma studies in April. On August 18, Curis stated that the partial clinical hold on the TakeAim Lymphoma study was lifted.