To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Grants Orphan Drug Status to Genasense for Three Cancer Indications URL: http://www.pslgroup.com/dg/205542.htm Doctor's Guide September 4, 2001
BERKELEY HEIGHTS, NJ -- September 4, 2001 -- Genta Incorporated announced today that Genasense™, its lead anticancer compound, has been granted orphan drug status for three additional cancer indications by the U.S. Food and Drug Administration (FDA). The designations apply to the Company's applications for such status that were filed in May, 2001 for treatment of patients with multiple myeloma, acute myelocytic leukemia, and chronic lymphocytic leukemia.
Genasense had previously been granted such status for the treatment of patients with malignant melanoma. Orphan drug status provides for a period of marketing exclusivity, certain tax benefits, and an exemption from certain fees at the time of submission for marketing approval of a new drug application (NDA).
"The Company currently has active clinical trials in all four of the indications that have been granted orphan drug Status by FDA, three of which are randomized studies," said Dr. Loretta M. Itri, Genta's Executive Vice-President for Clinical Research and Chief Medical Officer, who also noted: "We remain pleased with the accrual in all of these studies. Assuming a positive result, we remain on track to file our first NDA for Genasense in one of these indications next year."
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