Curis ( NASDAQ: CRIS ) said the U.S. Food and Drug Administration (FDA) allowed patient enrollment to resume in the monotherapy phase of the TakeAim Leukemia study.
Earlier in August, the FDA had lifted a partial clinical hold on a phase 1/2 trial (TakeAim Lymphoma) of emavusertib in lymphoma after reviewing data submitted by the company. In April, the FDA had placed separate partial clinical holds on the TakeAim Leukemia and TakeAim Lymphoma studies.
Curis said in an Aug. 30 press release that the partial hold remains in place for the combination therapy phase (phase 1b) and the expansion phase (phase 2a) of the study until phase 1a is complete and the FDA approves proceeding to the next phases of the trial.
After reviewing the data submitted by Curis, the FDA has now allowed enrollment of additional patients in the monotherapy dose finding phase (phase 1a) of the TakeAim Leukemia study.
The hold on the Leukemia study was carried out after the death of a patient with acute myeloid leukemia who experienced rhabdomyolysis — damage to muscle tissue — a previously identified dose-limiting toxicity of the candidate.
Curis said the FDA reviewed additional data related to the risk of rhabdomyolysis, the company's strategy for using objective laboratory measurements to identify rhabdomyolysis, and the company's strategy to manage rhabdomyolysis, if it is detected.
The company noted that it was working with clinical sites to resume enrollment.
Curis expects preliminary clinical data update from the TakeAim Leukemia study in 2023.
CRIS -1.79% to $1.10 premarket Aug. 30
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Curis leukemia study's monotherapy part gets FDA nod to resume enrollment, others still under partial hold