Genasense(R) Chemotherapy Program Yields High Response Rate in Patients with Stage ... ( Related Clinical Study Shows Potent...)

Genasense(R) Chemotherapy Program Yields High Response Rate in Patients with Stage 4 Melanoma

Date:5/30/2008

Related Clinical Study Shows Potential Utility of Short-Course High-Dose

Therapy

BERKELEY HEIGHTS, N.J., May 30 /PRNewswire-FirstCall/ -- Genta Incorporated (OTC Bulletin Board: GNTA) announced preliminary results that have shown a high objective response rate in a pilot study that incorporates the Company's lead oncology product, Genasense(R) (oblimersen sodium) Injection, in a chemotherapy program for patients with advanced melanoma. In this study, Genasense was used to potentially enhance the clinical activity of temozolomide (Temodar(R); Schering Plough, Inc.), the most commonly used anticancer drug for melanoma, combined with Abraxane(R) (paclitaxel protein-bound particles for injectable suspension; Abraxis Bioscience, Inc.). The data will be featured in a presentation at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago on June 1, 2008.

All 14 of the first cohort of patients accrued to this study had non-resectable 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 blood marker that was shown to affect the response to Genasense plus chemotherapy in a recent randomized trial.) To date, 6 patients (43%) have achieved major objective responses: one with complete response (CR) after 6 cycles of treatment, and 5 with at least a partial response after only one treatment cycle. Three additional patients have maintained stable disease (SD) after at least three treatment cycles, for an overall clinical benefit response (CR+PR+SD) of 64%.

Laboratory studies showed that Genasense did not alter the expected pharmacokinetics of paclitaxel, and that clinical response was associated with alterations in Bcl-2, a protein that is the molecular target of Genasense. No dose-limiting toxicity was observed. The most commonly observed side-effects were similar to those encountered wi
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Related medicine technology :

1. Genta Initiates Phase 3 AGENDA Trial of Genasense(R) for Patients with Advanced Melanoma
2. Genasense(R) Data in Melanoma to be Presented in Opening Session at First Worldwide Melanoma Center Meeting of the European Association of Dermato-Oncology
3. Authorization for AGENDA Phase 3 Trial of Genasense(R) in Advanced Melanoma Granted by French Regulatory Agency
4. Genasense(R) Can be Administered by Brief High-Dose IV Infusion
5. Genasense(R) Data in Patients with Advanced Melanoma to be Featured at 4th International Melanoma Congress
6. FDA to Extend Review of Data Quality Submission for Genasense(R) in Melanoma
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8. FDA Indicates That Genasense(R) Approval in Chronic Lymphocytic Leukemia Will Require Additional Confirmatory Data
9. DSMB Supports Continuation of Phase 3 AGENDA Trial of Genasense(R) in Advanced Melanoma
10. Specialized Genasense(R) Clinical Trials Featured at AACR Meeting
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