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Genasense® Combined with Temodar® and Abraxane® Shows Preliminary Evidence of High Response Rates and Extended Survival in Patients with Advanced Melanoma
2009 JUN 22 - (NewsRx.com) -- Genta Incorporated (OTCBB: GNTA) announced preliminary results that show a high objective response rate and potentially extended survival in an ongoing pilot study that incorporates the Company's lead oncology product, Genasense® (oblimersen sodium) Injection, in a chemotherapy program for patients with advanced melanoma. The data were featured this week in a presentation at the annual meeting of the American Society of Clinical Oncology (ASCO) in Orlando, FL. Based on preclinical evidence of synergy, Genasense was combined with temozolomide (Temodar®; Schering Plough, Inc.), the most commonly used anticancer drug for melanoma, plus ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension [albumen bound]; Abraxis Bioscience, Inc.). To date, 18 patients have been accrued, all of whom had unresectable stage 4 melanoma. None had previously received chemotherapy, and their baseline LDH did not exceed 1.1 times the upper limit of normal. (LDH is a tumor-derived biomarker that has been associated with outcome in melanoma and other diseases.) To date, 7 patients (39%) have achieved major objective responses: one with complete response (CR) after 6 cycles of treatment, and 6 with at least a partial response after a minimum of 2 treatment cycles. Five patients have maintained stable disease (SD) after at least 3 treatment cycles (24 weeks), for an overall disease control rate (CR+PR+SD) of 68%. The most commonly observed side-effects were similar to those associated with the chemotherapy drugs used alone, including leukopenia, thrombocytopenia, neuropathy, and hair loss. Overall median survival for all patients irrespective of response was 14.7 months, and 50% of patients have survived greater than 1 year. The patient who achieved a complete response has stopped all therapy and remains without recurrence for 20+ months. The single patient with ocular melanoma, a rare and highly aggressive subtype, survived for 15 months. These data compare very favorably with median survival reported in the randomized Phase 3 trial of patients with advanced melanoma and similar LDH criteria using dacarbazine alone (9.7 months) or dacarbazine plus Genasense (11.4 months) (Bedikian A, et al., J Clin Oncol. 24:4738, 2006). Keywords: , Health, Biotechnology, Clinical Trials, Oncology, Pharmaceutical, Bioscience, Chemicals, ChemistryAbraxis BioScience Inc., Anticancer Therapy, Biotechnology Business, Biotechnology Company, Chemotherapy, Clinical Oncology, Clinical Trial Research, Clinical Trials, Drug Therapy, Drugs, Genta Incorporated, Melanoma, Oncology, Paclitaxel, Pharmaceutical Business, Pharmaceutical Company, Pharmaceuticals, Pre-Trials Research, Schering-Plough Corporation, Temozolomide, Therapy, Treatment. This article was prepared by Biotech Business Week editors from staff and other reports. Copyright 2009, Biotech Business Week via NewsRx.com.
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