FOSTER CITY, Calif. - Notable Labs, Ltd. (NASDAQ: NTBL), a clinical-stage therapeutics company, has announced the progression of its Phase 2 clinical trial for volasertib, a treatment for relapsed/refractory acute myeloid leukemia (r/r AML). The trial will utilize Notable's Predictive Precision Medicine Platform (PPMP) to identify patients likely to respond to the treatment, aiming to improve outcomes and streamline drug development.
Volasertib, a PLK-1 inhibitor, showed promise in earlier trials conducted by Boehringer Ingelheim. Notable's PPMP, which recently predicted clinical trial outcomes with 100% accuracy for another drug, fosciclopirox, will be used to select patients for the volasertib study. This targeted approach is expected to enhance the drug's clinical response rate and overall patient outcomes.
The Phase 2 trial, set to initiate in the second quarter of 2024, will be an open-label study combining volasertib with decitabine. The trial design includes a non-selective dose optimization prelude with a small cohort of patients, followed by the enrollment of PPMP-selected patients predicted to respond to the treatment. The primary endpoints will be the predicted response rate and a per-protocol response assessment of complete remission and overall survival. The prelude data is anticipated in the fourth quarter of 2024.
Notable's CEO, Dr. Thomas Bock, expressed confidence in the PPMP's ability to reduce the number of patients needed for the trial and to focus on those most likely to benefit from volasertib.
Volasertib has been granted breakthrough therapy designation by the FDA in the past, and Notable holds exclusive worldwide development and commercialization rights, with the exception of certain rare pediatric cancers. The company's PPMP is designed to select clinically responsive patients before treatment, potentially accelerating clinical development and delivering treatments more effectively.
The information in this article is based on a press release statement.
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