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news.AEterna Zentaris has initiated a European multi-center phase II trial to evaluate the efficacy, safety and tolerability of its Spectrum Pharmaceuticals co-developed, D-63153, in patients with benign prostate hyperplasia.
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D-63153 is a fourth generation luteinizing hormone-releasing hormone (LHRH) antagonist. The trial will evaluate the efficacy of D-63153 as measured by its effects on clinical signs and symptoms characteristic of benign prostate hyperplasia (BPH). These include the international prostate symptom score (IPSS) and maximum uroflow, as well as the durability of therapeutic response over several months.
This trial will be fully funded by Spectrum Pharmaceuticals, AEterna Zentaris’ US development partner for D-63153.
“We are very pleased to see the timely initiation of this second phase II trial of D-63153,” said Professor Jurgen Engel, executive vice president of global R&D and COO of AEterna Zentaris.
“We believe that D-63153, which allows for chronic intermittent treatment, has the potential to improve clinical symptoms of BPH while overcoming some of the limitations associated with currently marketed therapies, including the need for daily administration and side effects such as erectile dysfunction and loss of libido.”