Genta Initiates Phase 3 AGENDA Trial of Genasense(R) for Patients with Advance...(o target novel therapiesfor melanoma. ....),Health

"I am pleased that the European Association of Dermato-Oncology (EADO) will be the lead international cooperative group for AGENDA," said Dr. Claus Garbe, Professor of Dermatology and Head of the Division of Dermatooncology, Department of Dermatology, University Medical Center, Tubingen, Germany. "The use of LDH to pre-select individuals who are disproportionately likely to benefit represents an important innovation for patient treatment."

"The Genasense/dacarbazine trial represents our highest treatment priority for patients with advanced melanoma," said Dr. Sanjiv Agarwala, Chief of Medical Oncology, St. Luke's Hospital and Health Network, Allentown, PA. "With our center now actively enrolling patients, we look forward to rapidly confirming the exciting results previously obtained in individuals with low- normal LDH."

About Genasense in Advanced Melanoma

Genasense, Genta's lead anticancer drug, is a novel targeted therapy that blocks the production of Bcl-2, a protein that appears to be a fundamental cause of cancer treatment resistance. By knocking down Bcl-2, Genasense may enhance the effectiveness of chemotherapy in patients with advanced melanoma. Genasense in melanoma has Orphan Drug designations in Australia and the U.S., along with Fast Track designation in the U.S.

In its initial Phase 3 trial, Genta performed the largest randomized controlled trial that has ever been conducted in patients with advanced melanoma. In that trial, 771 patients were randomly assigned to receive chemotherapy with DTIC alone or in combination with Genasense. A scientific article that describes efficacy and safety results from this study can be accessed at: http://www.jco.org/cgi/content/abstract/JCO.2006.06.0483v1.

In that trial, patients were also prospectively stratified according to blood levels LDH. Further analysi
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SOURCE Genta Incorporated Copyright©2007 PR Newswire.

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