Notable Reports Predictive Precision Medicine Platform (PPMP) Accurately Predicted Fosciclopirox Trial Outcome

- PPMP Accurately Predicted Patient Outcomes in Fosciclopirox Phase 2a Leukemia Trial -

- Predictive Results Further Advance PPMP and Corroborate Outcomes from 4 PPMP Validation Trials -

- Furthers Opportunity to Accelerate PPMP Use in Front-End Drug Development -

FOSTER CITY, Calif. and KANSAS CITY, Mo., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Notable Labs, Ltd. (“Notable”) (Nasdaq: NTBL), a clinical-stage therapeutic platform company developing predictive precision medicines for cancer patients, and CicloMed, LLC (“CicloMed”), a developmental-stage pharmaceutical company focusing on unmet medical needs in oncology, today announced initial safety and efficacy data of fosciclopirox and the performance of PPMP, Notable’s Predictive Precision Medicines Platform, from the Phase 2a trial in adult patients with relapsed/refractory acute myeloid leukemia, R/R AML (NCT04956042). Fosciclopirox is sponsored by CicloMed and co-developed by both companies. In the Phase 2a trial, PPMP-predicted patient responses were confirmed by the actual responses to treatment.

“The successful outcome prediction means that Notable’s PPMP platform accomplished its goal in this trial,” stated Thomas Bock, M.D., Chief Executive Officer of Notable. “These data further corroborate and extend our four independent PPMP validation trials in collaboration with leading medical centers*.”

Fosciclopirox, a patented, parentally administered prodrug of a commercially available topical antifungal agent, ciclopirox, is being developed for the treatment of bladder cancer and AML.

This Phase 2a study was designed to characterize the safety and efficacy of fosciclopirox in R/R AML and, in parallel, to test PPMP’s ability to predict patient responses to treatment. Patients were not selected for enrollment based on PPMP results and, to avoid potential bias, PPMP analysis was blinded to the actual patient outcomes during the trial. Clinical efficacy in this heavily pretreated group of patients was defined by standard criteria in AML medical research and practice.

Eighteen heavily pre-treated patients were enrolled in the trial with nine patients evaluable for response assessment per-protocol. Fosciclopirox, administered at the Recommended Phase 2 Dose, was well-tolerated. However, none of the nine evaluable patients achieved a complete response. Stable disease, over four months, was observed in two evaluable patients.