Daewoong Pharmaceutical Reports Phase IV Clinical Trials of Prostate Cancer Treatment Drug (GnRH Agonist) Luphere®

Prostate cancer growth stimulant testosterone maintained near castrate levels in 97% of patients On September 1st, the phase IV clinical trial results of Daewoong Pharmaceutical’s (president: Jong-Wook Lee) cancer treatment drug (GnRH Agonist) Luphere® Depot Inj (leuprolide acetate) was reported in The Korean Journal of Urological Oncology, and was reported to have superior effectiveness and safety. At the Council of the Korean Urological Oncology Society, held at the convention center of Hotel Inter-Burgo, Daegu, the chairman of research of the Society and professor of urology at Pusan University, Moon-Gi Jung reported, “In the phase IV clinical trials, testosterone, which stimulates prostate cancer cell growth have dropped to lower than castrate levels (50ng/dL) in 97% of all patients after 12 weeks of Luphere® Depot Injections. Also, PSA (prostate specific antigen) concentration of 76.88ng/mL dropped 95% to lower than normal levels (4ng/mL) of 3.59ng/mL.” Also he reported, “Safety evaluations revealed no major abnormal chemical reactions and only minor ones showing its superior safety.” The phase IV clinical trials of Luphere® reported at the Council of the Korean Urological Oncology Society were conducted under the supervision of the Society at Samsung Medical Center, Seoul, and 12 other major hospitals throughout the country. 96 patients were injected for 12 weeks with Luphere® Depot Inj (3.75mg) and tested for testosterone level, PSA concentration, and safety. Sales of Luphere® Depot Injections began in February 2005, and it is an anti-cancer drug (GnRH Agonist) containing leuprolide co-developed by Daewoong Pharmaceutical and bio-venture company Peptron. It shows excellent effectiveness against prostate cancer, breast cancer, myoma of the uterus, endometriosis, and central precocious puberty. It was developed using the world’s first slow releasing spray-dried method, and is gelatin free, improving safety,   duration, and production efficiency. Injections are convenient and come in either the free-field type that are safe from external contamination or the 3 month type. It was licensed in Vietnam last year and it is expected to be licensed in China later this year. Other world markets are being explored, including Japan, Europe, and North America.

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