CytRx (CYTR) Reports Favorable Phase 2 ENABLE in Certain B-CLL Patients
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CytRx Corporation (Nasdaq: CYTR), reports results from the open-label, single-agent Phase 2 ENABLE proof-of-concept clinical trial demonstrate bafetinib’s clinical activity and preliminary safety in patients with relapsed or refractory B-cell chronic lymphocytic leukemia (B-CLL). The results were presented by Tapan Kadia, M.D., Department of Leukemia at the University of Texas, M.D. Anderson Cancer Center, in a poster session at the 2011 American Society of Hematology (ASH®) Annual Meeting. CytRx also announced that the ENABLE abstract has been selected for inclusion in the Highlights of ASH® program for presentation in 2012 in ASH meetings in Austin, Orlando, Atlanta, Las Vegas, New York and San Francisco.
Each of the 18 late-stage B-CLL patients enrolled in the ENABLE trial had been treated with and failed between one and six therapies, with a median of three, and 14 of the 18 patients (87%) having unfavorable cytogenetics. Patients were treated with orally administered bafetinib twice daily. Six of 12 (50%) of the evaluable patients achieved 30% or greater shrinkage of the lymph node and spleen, and four of 12 (33%) patients had stable disease. No serious adverse events (SAEs) were observed at the dose of 240 mg twice daily, which is the dose that would likely be used in any future clinical trials in chronic lymphocytic leukemia. Two patients remain in the trial, which is being conducted at the M.D. Anderson Cancer Center and City of Hope Medical Center.
Each of the 18 late-stage B-CLL patients enrolled in the ENABLE trial had been treated with and failed between one and six therapies, with a median of three, and 14 of the 18 patients (87%) having unfavorable cytogenetics. Patients were treated with orally administered bafetinib twice daily. Six of 12 (50%) of the evaluable patients achieved 30% or greater shrinkage of the lymph node and spleen, and four of 12 (33%) patients had stable disease. No serious adverse events (SAEs) were observed at the dose of 240 mg twice daily, which is the dose that would likely be used in any future clinical trials in chronic lymphocytic leukemia. Two patients remain in the trial, which is being conducted at the M.D. Anderson Cancer Center and City of Hope Medical Center.
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