GemVax & Kael announced on the 18th that a paper on the Phase 3 clinical trial of GV1001 for benign prostatic hyperplasia was published in the international journal Prostate International on the 11th.
Prostate International, the official journal of the Asia Pacific Prostate Society (APPS) and the Korean Prostate Society (KPS), is an international academic journal that publishes the latest papers in the fields of basic and clinical medicine related to prostate diseases.
The paper titled "A Randomized, Multicenter, Phase 3 Study on the Efficacy and Safety of GV1001 in Patients with Benign Prostatic Hyperplasia" reports the results of a study conducted on a total of 423 patients with benign prostatic hyperplasia at 17 leading institutions in Korea.
According to the paper, GV1001 showed an improvement in lower urinary tract symptoms equivalent to the control group taking 5 mg of finasteride. It did not affect sexual function. Finasteride, which requires more than six months of administration to reduce prostate size, can cause side effects such as decreased libido and erectile dysfunction with long-term use; however, GV1001 was confirmed not to affect sexual function.
Prostate-specific antigen (PSA) is an important tumor marker for the diagnosis and treatment of prostate cancer. When taking finasteride, PSA levels decrease, which can delay or miss the diagnosis of latent prostate cancer. The paper showed that GV1001 did not affect PSA levels.
Professor Kyungseop Lee of Keimyung University Dongsan Hospital stated, "This study is a large-scale research confirming that GV1001 has similar therapeutic effects and drug safety to finasteride through anti-inflammatory and anti-fibrotic actions," adding, "It is expected that it can be applied clinically through further research."
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