Threshold’s prostate drug enters late stage European trial

Benign prostatic hyperplasia (BPH) can restrict the flow of urine, resulting in urine retention, which can cause weakening of the bladder wall and the inability to empty the bladder completely. The study will measure the dosing, safety, and effectiveness of the drug.

BPH, also known as benign enlargement of the prostate, is the most common urological problem among older men and affects an estimated 18 million men in the United States, 28 million men in five major European countries and eight million men in Japan.

It can be progressively severe, with a risk of urinary tract infection, kidney and bladder damage, bladder stones and incontinence. However, current drug and surgical therapies for BPH are not completely effective, often having slow onset and with side effects ranging from decreased libido, sexual dysfunction and reduced quality of life to cardiovascular effects and/or surgical complications.

Threshold Pharmaceuticals’ phase III trial into the disorder will enroll approximately 480 men of 50-80 years of age with symptomatic BPH. The company’s primary objective will then be to evaluate the efficacy of TH-070 (50 mg, 150 mg) compared to placebo.

“We are excited about the potential of this therapy based on promising phase II clinical data,” said Alan Colowick, chief medical officer of Threshold. “This is another important clinical milestone in our registrational program. The phase III European trial complements our phase II trial recently begun in the United States.”