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Genasense Trial in CLL Shows Increase in Duration of Major Responses

May 16, 2005

Genta has updated results from the company's Phase III trial of Genasense (oblimersen sodium) injection in patients with relapsed or refractory chronic lymphocytic leukemia.

Preliminary results of this trial announced in December 2004 showed that the trial had achieved its primary endpoint, which was to demonstrate a statistically significant increase in the proportion of patients who achieved either a complete response (CR) or a nodular partial response (nPR).

With an additional six months of follow-up, one additional patient in the Genasense treatment group has achieved an nPR. Overall, 20 patients (17 percent) in the Genasense plus chemotherapy group achieved a CR or nPR compared with eight patients (7 percent) in the chemotherapy only group.

Moreover, extended follow-up has now shown that the duration of CR/nPR is significantly superior for patients in the Genasense treatment group. Five of eight patients have relapsed on the chemotherapy only arm compared with four of 20 patients on the Genasense treatment arm.