Genta Incorporated (OTCBB: GETA.OB) announced preliminary results that show a high objective response rate in a pilot study of patients with advanced melanoma that incorporates the Company’s lead oncology product, Genasense® (oblimersen sodium) Injection, administered for the first time as a 1-hour high-dose intravenous (IV) infusion. The data were featured this week in a presentation at the annual World Meeting of Interdisciplinary Melanoma/Skin Cancer Centers in Berlin, Germany.
Based on preclinical evidence of synergy, this study combined Genasense with temozolomide (Temodar®; Schering Plough, Inc.), the most commonly used anticancer drug for melanoma, and Abraxane® (paclitaxel protein-bound particles for injectable suspension [albumen bound]; Abraxis Bioscience, Inc.). Previous results using a standard dose and schedule of Genasense (i.e., approximately 500 mg infused over 24 hours daily for 7 days) suggested this investigational combination was associated with clinical activity and good tolerability in 18 patients.
In the new schedule, Genasense was administered with the same chemotherapy as a brief IV infusion over 1-hour twice per week for 4 consecutive weeks at a dose of 900 mg. This schedule compresses approximately 48 hours of standard dosing into a brief 1-hour infusion.