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Genta Incorporated Announces Second Quarter 2007 Financial Results and Corporate Highlights
Date:8/19/2007

of Genasense plus Dacarbazine Compared with Dacarbazine Alone in Patients with Advanced Melanoma". This trial will seek to evaluate the effectiveness of the Genasense/dacarbazine combination in patients identified in the preceding randomized trial of dacarbazine with or without Genasense (known as GM301) as having derived greatest benefit. AGENDA seeks to enroll patients using a readily available biomarker that multiple studies have confirmed as the most powerful indicator of prognosis. The trial will enroll approximately 300 patients and will be conducted at sites in North America, Europe and Australia. In July 2007, the Company announced that the European Medicines Agency indicated that approval of Genasense in melanoma will require the conduct of another clinical study, and the new trial is intended to address this requirement.

Chronic Lymphocytic Leukemia (CLL)

The Company announced that it will request review of the non-approvable decision by the Food and Drug Administration (FDA) for the New Drug Application (NDA) for Genasense in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Following FDA's established Dispute Resolution Process, Genta will submit its request to Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research (CDER), and the Company anticipates a decision from CDER in the second half of 2007.

"Named-Patient" Distribution Will Provide Patient Access to Genasense(R) and Ganite(R)

While the AGENDA trial is ongoing, Genta has elected to continue to provide both Genasense (oblimersen sodium) and Ganite(R) (gallium nitrate injection) on a compassionate-use/named patient basis. Genta established this program via a collaboration with IDIS, a U.K.-based company that will distribute the drug in territories outside the United States upon physician request for a specific patient. Going forward, the Company will levy a charge and record revenue for the provision of both agents under this prog
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SOURCE Genta Incorporated

Copyright©2007 PR Newswire.

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