GENTA RECEIVES NOT APPROVABLE LETTER FOR GENASENSE IN CLL

Genta announced it has received notice that its new drug application (NDA) for the use of Genasense plus chemotherapy in patients with chronic lymphocytic leukemia (CLL) has been deemed not approvable by the FDA.

"We are keenly disappointed by this decision," Raymond Warrell, Genta's CEO, said. "We believe that Genasense has amply demonstrated its efficacy and safety in patients with relapsed and refractory CLL in a carefully designed and executed randomized clinical trial. As we decide on next steps with this application, we will continue working to seek worldwide approval of Genasense for patients who have advanced cancer."

The FDA's Oncologic Drugs Advisory Committee had recommended against approving the application in September.

Genasense inhibits production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced apoptosis (programmed cell death). By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current anticancer treatment. Genta is pursuing a broad clinical development program with Genasense evaluating its potential to treat various forms of cancer.