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news.AEterna Zentaris and Spectrum Pharmaceuticals have initiated a European multi-center phase II trial to evaluate the safety and efficacy of D-63153 in patients with hormone-dependent prostate cancer.
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The phase II trial will further assess the ability of D-63153, a fourth generation LHRH (luteinizing hormone releasing hormone) antagonist, to suppress testosterone levels in a dose-dependent manner and will evaluate related anti-tumor activity based on objective tumor response.
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.
“We are very pleased with the advancement of clinical program for D-63153, and look forward to working with Spectrum to advance the program in additional indications”, said Gilles Gagnon, president and CEO of AEterna Zentaris. “We believe that LHRH antagonists such as D-63153 have several potential advantages in treating prostate cancer.”
AEterna Zentaris granted Spectrum Pharmaceuticals an exclusive license to develop and market D-63153 for all potential indications in North America (including Canada and Mexico) and India in August 2004. AEterna Zentaris retains exclusive rights to the rest of the world.