Ronald F. Tutrone, Jr., MD, FACS, presented “Fexapotide for BPH with an introduction from E. David Crawford, MD. 

How to cite: TutroneRonald F. “Fexapotide for BPH” January 27, 2018. Accessed May 2018. https://grandroundsinurology.com/Fexapotide-for-BPH/

Fexapotide for BPH

Summary:

Ronald F. Tutrone, Jr., MD, FACS, summarizes two Phase III clinical trials testing the safety and efficacy of fexapotide, a novel treatment for benign prostatic hyperplasia (BPH).

Fexapotide Application

Fexapotide is a first-in-class injectable protein for the treatment of BPH. Clinicians deliver 5 cc of the protein into the right and left transition zones of the prostate through a 22 gauge needle.   

Fexapotide Mechanism of Action

The mechanism of action for fexapotide is to cause selective apoptosis in the glandular portions of the prostate. In other words, it destroys cell organelles and leaves behind the stroma. Furthermore, animals testing shows that fexapotide causes no damage to organs surrounding the prostate.

Clinical Trials

A study looking at two Phase III clinical trials served as an illustration of fexapotide’s significant benefits. Among those benefits, BPH patients saw improvement in their International Prostate Symptom Score (I-PSS), especially regarding voiding symptoms.

Also, according to trials, the drug has no serious adverse events related to it, no risk of complications with repeat injections, and causes no detectable immune response. Overall, the protein injection is extremely safe. Furthermore, patients receiving the injection saw a reduction in spontaneous acute urinary retention and incidence of prostate cancer. As an additional positive effect, patients receiving fexapotide had improved SHIM score when compared to the placebo.