GemVax & KAEL said that it proved clinical efficacy of GV1001 on benign prostatic hyperplasia through a phase 2 trial and recently had its results published in the British Journal of Urology International.
“This paper, which was presented at both domestic and international conferences – has now been published in the BJUI,” CEO Song Hyoung-gon said.
The randomized, placebo-controlled, single-blind, parallel design, multicenter Phase II trial studied the effect of GV1001 on a total of 161 patients with benign prostatic hyperplasia.
Findings showed those in the GV1001 arm had a statistically significantly reduced International Prostate Symptom Score (ISS) and prostate volume compared to the placebo group. Those taking GV1001 also did not display any statistically significant adverse or side effects.
“The trial proved statistically significant reductions in patients’ ISS score and prostate volume while keeping the International Index of Erectile Function (IIEF) score same between the two patient groups,” said research lead Lee Kyung-seop from Dongguk University’s department of urology.
Lee noted that the research team had confirmed the therapy’s potential to treat benign prostatic hyperplasia. The company said it viewed the publication as a “green light” for starting domestic and global phase 3 trials.
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