Evaluate the Efficacy and Safety of GV1001 in Patients With Benign Prostatic Hyperplasia (BPH)

The current study is being conducted by the Sponsor to evaluate the efficacy and safety of GV1001 (0.56 mg and 1.12 mg) administered as a treatment for Benign prostate hyperplasia(BPH). The investigational drug, GV1001, was first developed as a cancer vaccine for use as active immunotherapy of cancer forms expressing telomerase (eg, pancreatic cancer, prostate cancer, etc.). Subsequently, it was found that GV1001 showed efficacy in alleviating BPH symptoms during in vivo studies by reducing the size of the prostate gland. Based on the result, the effectiveness of GV1001 as a treatment for BPH has been assessed in experimental animals that are designed to develop BPH. It is considered that GV1001 acts to alleviate BPH and the results obtained from previous phase II study indicate that GV1001 may provide potential beneficial effects in BPH patients. So this study is to verify the efficacy and safety of GV1001 on BPH population, large-scale clinical study than phase II.