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Genta Incorporated Announces Second Quarter 2008 Financial Results and Corporate Highlights
Date:8/7/2008

with dacarbazine in patients identified by a biomarker who have not previously received chemotherapy. The co-primary endpoints of AGENDA are progression-free survival and overall survival. This global trial is targeting the recruitment of 300 patients from Europe, the U.S., Canada, and Australia.

Genasense in Chronic Lymphocytic Leukemia (CLL): During the quarter, Genta submitted an amendment to its New Drug Application (NDA) for the use of Genasense plus chemotherapy in patients with relapsed/refractory CLL. The submission was based primarily on new information from the Company's completed, randomized Phase 3 trial that showed, among other findings, a significant increase in overall survival for patients who achieved a complete or partial response when treated with Genasense plus chemotherapy compared with patients treated with chemotherapy alone. Subsequently, FDA has notified the Company that it considers Genta's submission as a complete response and a Class 2 resubmission with a Prescription Drug User Fee Act (PDUFA) goal date for FDA's response of December 3, 2008. The submission requests marketing approval of Genasense for the proposed indication.

Tesetaxel: A Leading Oral Taxane with Anticancer Activity

In other regulatory activity, Genta submitted its response to a prior notice from FDA that had placed tesetaxel, a clinical-stage oral taxane, on full "clinical hold". During the quarter, the Company was notified by FDA that the clinical hold had been lifted and that Genta may resume clinical trials with tesetaxel.

Tesetaxel is the latest addition to the Genta oncology portfolio. The agent was developed to avoid serious effects associated with other taxanes (such as paclitaxel [Taxol(R); Bristol Myers Squibb] and docetaxel [Taxotere(R); sanofi aventis]), including severe infusion reactions, peripheral nerve damage, and drug resistance. More than 250 patients have received tesetaxel, and the drug has demonstrated anticancer activity
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Related biology technology :

1. Genta Announces Second Quarter 2008 Financial Results and Conference Call
2. Genta Receives Notice of Allowances for European Patents Related to Composition and Processes for Tesetaxel, a Leading Oral Taxane
3. Genta Submits NDA Amendment to FDA for Genasense as Treatment of Chronic Lymphocytic Leukemia
4. Genta Secures Up to $40 Million Convertible Financing Facility to Fund Key Programs
5. Genta Incorporated Announces First Quarter 2008 Financial Results and Corporate Highlights
6. Genta Announces Transfer of its Common Stock to the OTC Bulletin Board
7. Genta Announces Pending Transfer of its Common Stock to the Over-the-Counter Bulletin Board
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9. Syngenta To Build Major Global Biotech Research Center in Beijing, China
10. Genta Restructures Operations to Focus on Priority Initiatives
11. Genta Granted Extension to Achieve Compliance with NASDAQ Listing Requirements
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