Brief: Curis Announces FDA Partial Clinical Hold For Takeaim Leukemia Study Of Emavusertib

Curis

04/04/2022 12:11

April 4 (Reuters) - Curis Inc  CRIS.O :
    * CURIS ANNOUNCES FDA PARTIAL CLINICAL HOLD FOR TAKEAIM
LEUKEMIA
STUDY OF EMAVUSERTIB (CA-4948)
    * CURIS INC - WHILE PARTIAL HOLD IS IN PLACE, NO NEW
PATIENTS WILL
BE ENROLLED IN STUDY
    * CURIS INC - CURRENT STUDY PARTICIPANTS BENEFITTING FROM
TREATMENT MAY CONTINUE TO BE TREATED WITH EMAVUSERTIB AT DOSES
OF 300MG BID OR LOWER
    * CURIS - FDA REQUESTING ADDITIONAL DATA FROM STUDY,
INCLUDING
DATA RELATED TO DEATH OF A R/R AML PATIENT WHO EXPERIENCED,
AMONG OTHERS, RHABDOMYOLYSIS
    * CURIS - FDA ALSO REQUESTING SAFETY, EFFICACY, AND OTHER
DATA,
INCLUDING DATA RELATED TO RHABDOMYOLYSIS
    * CURIS - EXPECTS TO GIVE GUIDANCE ON TIMING OF DISCUSSING
POTENTIAL FOR RAPID REGISTRATIONAL PATH FOR EMAVUSERTIB AFTER
PARTIAL CLINICAL HOLD IS RESOLVED
    * CURIS - DECIDED TO PAUSE ENROLLMENT OF NEW PATIENTS IN
TAKEAIM
LYMPHOMA STUDY, PENDING RESOLUTION OF PARTIAL CLINICAL HOLD IN
TAKEAIM LEUKEMIA STUDY

Source text for Eikon:  ID:nPnbGVmDZa 
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