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Biotech / Medical : Genta, Inc. (GNTA)

GNTA 2.300

+0.4%

Nov 7 9:30 AM EST

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To: John Nobrega who started this subject	5/28/2004 3:52:53 PM
From: Ken S.	Read Replies (1) of 1870

Genta and Aventis Announce Termination of Genasense(TM) Expanded Access Program in Melanoma Friday May 28, 12:00 pm ET BERKELEY HEIGHTS and BRIDGEWATER, N.J., May 28 /PRNewswire-FirstCall/ -- Genta Incorporated (Nasdaq: GNTA - News) and Aventis (NYSE: AVE - News) today announced the termination of the Expanded Access Program (EAP) for Genasense(TM) (oblimersen sodium) Injection in combination with dacarbazine (DTIC). The decision to close the program was made subsequent to the May 3, 2004, meeting of the Oncologic Drug Advisory Committee (ODAC), at which the results of the Genasense Phase III metastatic melanoma trial were discussed. At that meeting, the committee voted that there was insufficient evidence to recommend approval at this time. The companies are working with the FDA to review key issues and to identify next steps related to further development of Genasense in advanced malignant melanoma. As previously announced on May 13, Genta withdrew its New Drug Application for Genasense in advanced malignant melanoma.

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