AEterna Zentaris Starts European Trial of D-63153

AEterna Zentaris has initiated a European multicenter Phase II trial to evaluate the safety and efficacy of D-63153, a fourth generation LHRH (Luteinizing Hormone Releasing Hormone) antagonist, in patients with hormone-dependent prostate cancer.

The Phase II trial will further assess the ability of D-63153 to suppress testosterone levels in a dose-dependent manner and related antitumor activity based on objective tumor response. This trial will be fully funded by Spectrum Pharmaceuticals, AEterna Zentaris' U.S. development partner for D-63153.

In a prior Phase I trial, evaluating multiple doses of D-63153 in 18 male volunteers, D-63153 injections were well-tolerated and demonstrated an immediate and dose-dependent suppression of testosterone plasma levels reaching castrate levels within the first 12 hours of application. The duration of suppression was dose-dependent, with the single injection of highest dose leading to testosterone suppression for 27 days.