Arsis

Oncternal Therapeutics Receives FDA Study May Proceed Letter for ONCT-534, its Novel Dual-action Androgen Receptor Inhibitor, for the Treatment of Patients with Advanced Prostate Cancer

Retrieved on: 
Thursday, August 3, 2023

The letter was received prior to the 30-day review date.

Key Points: 
  • The letter was received prior to the 30-day review date.
  • “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.

Zenith Epigenetics and Newsoara Announce Initiation of a Randomized Phase 2b Metastatic Castration-Resistant Prostate Cancer (mCRPC) Study

Retrieved on: 
Tuesday, September 21, 2021

The study will evaluate the efficacy of ZEN-3694 + enzalutamide vs. single agent enzalutamide as measured by its primary endpoint, radiographic free progression.

Key Points: 
  • The study will evaluate the efficacy of ZEN-3694 + enzalutamide vs. single agent enzalutamide as measured by its primary endpoint, radiographic free progression.
  • Abiraterone, also an ARSI, is frequently prescribed as a first line therapy for patients with metastatic prostate cancer.
  • Prostate cancer is the second-most commonly diagnosed cancer among men and the fifth most common cause of male cancer death worldwide.
  • Ovarian cancer in combination with immune-checkpoint inhibitors, nivolumab and ipilimumab in collaboration with the National Cancer Institute.