Gemvax&Kael released its phase-2 domestic clinical trial results of GV1001, a prostatic hyperplasia treatment, at the Asia Pacific Prostate Society on Oct. 12.
The research examined 161 patients with benign prostatic hyperplasia in a randomized, placebo-controlled, single-blind, parallel design and multicenter-controlled clinical trial at eight university hospitals to test its safety and efficacy.
"There was no adverse reaction or side effect from the drug,” said Lee Kyung-sup, a professor of urology at Dongguk University Gyeongju Hospital. "Patients treated with GV1001 showed the statistically significant decrease in the international prostate symptom score (IPSS).”
GV1001 not only improved the IPSS in the medication group but also decreased the prostate size and showed sufficient potential for the treatment of benign prostatic hyperplasia, he added.
Lee also emphasized that the fact there is no change in the international erectile dysfunction index in the medication group showed that GV1001 could overcome the sexual dysfunction which is considered to be a side effect of the existing treatment for benign prostatic hyperplasia.
"Based on the results of the trial, we plan to conduct phase 3 clinical trials in Korea as soon as possible,” said Song Hyoung-gon 송형곤, CEO of Gemvax& Kael 젬백스앤카엘. “The company will do its best to develop the treatment for benign prostatic hyperplasia, a representative geriatric disease.”
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