On August 3, 2023 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported the receipt of a Study May Proceed letter from the U.S. Food and Drug Administration (FDA), for a Phase 1/2 dose escalation study of ONCT-534, a novel dual-action androgen receptor inhibitor (DAARI), in patients with metastatic castration-resistant prostate cancer (mCRPC) who have relapsed or are refractory to approved androgen receptor signaling inhibitors (ARSIs) (Press release, Oncternal Therapeutics, AUG 3, 2023, View Source [SID1234633764]). The letter was received prior to the 30-day review date.
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"We are very pleased with the FDA’s authorization to proceed with our Phase 1/2 clinical trial of ONCT-534," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "Many men suffering from prostate cancer that has relapsed or is refractory after treatment with standard of care ARSI therapy, such as enzalutamide or abiraterone, need additional treatment alternatives. We believe that ONCT-534’s novel mechanism of action may help address key tumor escape mechanisms that cause such resistance. Preclinical studies suggest that ONCT-534 binds to both the ligand-binding domain (LBD) and N-terminal domain of the androgen receptor (AR), inhibiting AR function and triggering AR protein degradation, even in the presence of ligand-binding domain alterations including mutations and splice variants such as AR-V7. Clinical sites that will conduct the initial dose finding study for ONCT-534 have been selected and we expect to report preliminary data in the first half of 2024".