Spectrum Pharmaceuticals, Inc. has launched a multi-centre phase 2 clinical trial to evaluate the safety and efficacy of SPI-153 as a treatment for patients with benign prostatic hypertrophy (BPH).
The multi-centre clinical trial is designed to evaluate both objective parameters, such as improvement in urine flow and shrinkage of the prostate volume, as well as various symptoms of BPH over a period of several months. The trial will be conducted in Europe with the collaboration of AEterna Zentaris Inc., the parent of Spectrum's licensor of SPI-153 (D-63153).
"We are eager to pursue our studies of SPI-153 as an option for patients with BPH, a disease that represents a significant challenge to their quality of life," Rajesh Shrotriya, Chairman of the Board, CEO and President of Spectrum Pharmaceuticals, Inc said adding, "Previous studies have shown a dose-dependant testosterone suppression, leading us to believe that SPI-153 has the potential to reduce both the prostate size and corresponding symptoms, diminishing the impact of this prevalent health problem."
Benign prostatic hypertrophy 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, benign prostatic hypertrophy 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 benign prostatic hypertrophy 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.
SPI-153 is a fourth generation LHRH (Luteinizing Hormone Releasing Hormone), also known as GnRH (Gonadotropin Releasing Hormone) antagonist. LHRH antagonists have the potential to treat hormone-dependent cancers as well as benign proliferative disorders such as benign prostatic hypertrophy.