기사본문
Gemvax, phase 3 trial approval for BPH treatment in Korea
입력 2019-04-11 09:47 수정 2019-04-11 09:47
by Jongwon Jang
Gemvax & Kael will begin to have phase 3 clinical trial started for ‘GV1001’, a treatment of Benign Prostate Hyperplasia, in Korea.
Gemvax announced on the 5th that they received an approval from KFDA for ‘GV1001’ of the phase 3 clinical trial for Investigational New Drug (IND) in Korea.
Thus, Gemvax will administer GV1001 to the patients with BPH for 24 weeks to check the safety and efficacy of the drug. This clinical trial will take place at more than 20 hospitals nationwide
Previously, Gemvax reported that GV1001 not only improved the International Prostate Symptom Score (IPSS), but also reduced the prostate volume with statistically significant amount compared to the control group through the phase 2 clinical trials of 161 patients in 2017.
In addition, no abnormal findings were found in the International Index of Erectile Function (IIEF) in the medication group, suggesting the possibility of a treatment with no sexual dysfunction, which is considered to be one of the several side effects of some treatments for enlarged prostate.
The results of the phase 2 clinical trials of Gemvax were published in the Korean Prostate Society, which has the highest authority in the field of prostate disease in March 2018 and published in the British Journal of Urology International (BJUI) in April. Also, Nature Reviews Urology, Nature’s sisterhood, mentioned the possibility of GV1001 as a treatment of BPH.
