BERKELEY HEIGHTS, NJ, September 4, 2001
- Genta Incorporated (Nasdaq: GNTA) announced today that the
Company has received notice from the U.S Food and Drug
Administration that Genasense
TM
, its lead anticancer compound, has been granted designation as an
"Orphan Drug" for three additional cancer indications. The
designations apply to the Companys 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
TM
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 submission for marketing
approval of a New Drug Application.
"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,
Gentas 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
TM
in one of these indications next year."
