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Patient Enrollment for Phase 2 Trial of Ozarelix Complete, Potential Treatment for Benign Prostatic Hyperplasia
"We are pleased to have already achieved full patient enrollment for this Phase II trial in BPH which only started last April", stated Dr. Jurgen Engel, Executive Vice President, Global R&D and Chief Operating Officer at AEterna Zentaris. "In August of this year, we had previously announced the completion of patient enrollment for a current Phase II trial with ozarelix in prostate cancer, again, a full four months in advance. These milestones reflect the quality of our partnership with Spectrum Pharmaceuticals for the development of ozarelix in both indications."
Gilles Gagnon, AEterna Zentaris President and Chief Executive Officer added, "The swift patient enrollment in both prostate cancer and BPH trials reinforce the confidence of our investigators in the potential benefit of ozarelix, the second lead product in our Luteinizing Hormone Releasing Hormone antagonist therapeutic approach. It also emphasizes our commitment to advance products through the pipeline as quickly as possible for the benefit of patients in need of innovative and efficient therapies that can improve their quality of life."
Benign prostatic hyperplasia has marked adverse symptoms such as increased frequency of urination and difficulty in passing urine. Because ozarelix is expected to have dual effects, by first directly shrinking the prostate and second, through controlled reduction in the amount of testosterone (testosterone fuels the prostate gland), it is hoped that a single injection of ozarelix, repeated every few months, may be able to reduce the size of the prostate as well as accompanying symptoms.
About Ozarelix (D-63153) and Development Alliance with Spectrum
Ozarelix is a fourth generation LHRH (Luteinizing Hormone Releasing Hormone) antagonist administered as a depot formulation for the treatment of hormone-dependent prostate cancer and benign prostatic hyperplasia.
About Benign Prostatic Hyperplasia (BPH)
Benign prostatic hyperplasia (BPH) is a non-cancerous enlargement of the prostate frequently occurring in men over the age of 50. The enlargement can result in the gradual squeezing of the urethra, resulting in increased frequency or difficulty in urinating. Enlargement of the prostate is controlled by testosterone. According to the National Institutes of Health, BPH affects more than 50% of men over the age of 60 and as many as 90% of men over the age of 70. Treatment options for BPH include surgery and medications to reduce the amount of tissue and increase the flow of urine. Current treatment options are inconvenient, leading to ineffective compliance and are only effective in roughly half of the patients treated.
Source: AEterna Zentaris Inc.