Genta, Inc (fka GNTAQ)

[Renee]

From the year-end 10K : Previous analyses had shown a significant survival benefit accrued to patients in the Genasense ® group who attained COMPLETE RESPONSE . Extended follow-up showed that all major responses (complete response / partial response ) achieved with Genasense ® were associated with significantly increased survival compared with all major responses achieved with chemotherapy alone ( median = 56 months vs. 38 months , respectively ). After 5 years of follow-up , 22 of 49 (45%) responders in the Genasense ® group were alive compared with 13 of 54 (24%) responders in the chemotherapy-only group . Moreover, with 5 years of follow-up , 12 of 20 patients (60%) in the Genasense ® group who achieved COMPLETE RESPONSE were alive , 5 of these patients remained in continuous COMPLETE RESPONSE without relapse , and 2 additional patients had relapsed but had not required additional therapy . By contrast , only 3 of 8 COMPLETE RESPONSE patients in the chemotherapy-only group were alive , all 3 had relapsed , and all 3 had required additional anti-leukemic treatment .

We believe that the significant survival benefit associated with major responses to Genasense ® may provide the confirmatory evidence of clinical benefit that was requested by FDA.