Gemvax & Kael said Friday that the Ministry of Food and Drug Safety has approved its phase 3 clinical trial of GV 1001 as a treatment for benign prostatic hyperplasia (BPH).
|GemVax & KAEL headquarters in Seongnam, Gyeonggi Province.|
The company plans to test the safety and efficacy of GV1001 for 24 weeks in patients with BPH at 20 local medical institutions. Its phase 2 clinical trial results previously showed that the drug candidate significantly decreased the international prostate symptom score (IPSS), and reduced the prostate’s size.
The treatment also portrayed no change in international erectile dysfunction index, thereby overcoming the sexual dysfunction considered to be a side effect of the existing treatment for BPH.
“We plan to evaluate the efficacy and safety of GV1001 as a treatment of BPH, and proceed to apply for sales approval as soon as possible,” a company official said.