Kairos Pharma, Ltd. (NYSE American: KAPA) announced the completion of the safety lead-in arm of its Phase 2 clinical trial for ENV105. This trial is evaluating ENV105 for the treatment of metastatic, castration-resistant prostate cancer.
The safety lead-in portion of the study combined apalutamide, a standard of care for prostate cancer, with the company’s compound ENV105. The successful completion of this arm is essential for establishing the safety and preliminary efficacy of the combination therapy before proceeding with the randomized portion of the trial.
The company expects to announce the safety and efficacy data readout from this safety arm in the first half of 2025. Enrollment for the randomization arm of the study is ongoing at key cancer centers in Los Angeles and Salt Lake City, with the trial also validating biomarkers to identify patients most likely to benefit from the therapy.
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