GENTA PRESENTS NEW ANALYSES FROM GENASENSE STUDY IN CLL

Genta has presented new analyses from the company's randomized Phase III trial of Genasense (oblimersen sodium) injection in patients with relapsed or refractory chronic lymphocytic leukemia (CLL).

In patients who were prospectively stratified as being non-refractory, Genasense-treated patients were four times more likely to achieve complete remission compared with patients treated with chemotherapy alone. Moreover, these non-refractory patients also achieved a statistically significant increase in overall survival. These and other analyses comprised information submitted by Genta to the FDA last month.

In the trial 241 patients with relapsed or refractory CLL were randomly assigned to receive fludarabine plus cyclophosphamide (Flu/Cy) chemotherapy with or without Genasense. This trial -- the first randomized study ever conducted in this patient population -- achieved its primary endpoint, which was a statistically significant increase in the proportion of patients who achieved a complete or nodular partial response (CR/nPR). In addition, the duration of CR/nPR was significantly longer for patients treated with Genasense.

Prior to randomization in this trial, patients were prospectively stratified according to three criteria that reflected their responsiveness to prior chemotherapy. The CR/nPR response to Flu/Cy alone was both equally poor (6 to 7 percent) and numerically inferior in all stratification groups. Nonetheless, clear trends were evident across all strata, which suggested the best response to Genasense was achieved in patients who had received less extensive therapy.