FDA extends review of Genasense NDA appeal in chronic lymphocytic leukemia

Jan 15 2008

Genta Incorporated has announced that the Food and Drug Administration (FDA) has extended its review of Genta's appeal of the non- approvable decision for a New Drug Application (NDA) that proposed the use of Genasense (oblimersen sodium injection) plus chemotherapy in patients with relapsed or refractory chronic lymphocytic leukemia.

The Company had previously provided guidance that a final decision would be available in the fourth quarter of 2007. Genta now envisions receiving this notification later in the current quarter.

Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. Two major programs anchor the Company's research platform: DNA/RNA-based Medicines and Small Molecules. Genasense(R) (oblimersen sodium) Injection is the Company's lead compound from its DNA/RNA Medicines program. Genta is currently recruiting patients to the AGENDA Trial, a global Phase 3 trial of Genasense in patients with advanced melanoma. The leading drug in Genta's Small Molecule program is Ganite(R) (gallium nitrate injection), which the Company is exclusively marketing in the U.S. for treatment of symptomatic patients with cancer related hypercalcemia that is resistant to hydration. The Company has developed G4544, an oral formulation of the active ingredient in Ganite, that has recently entered clinical trials as a potential treatment for diseases associated with accelerated bone loss. Ganite(R) and Genasense(R) are available on a "named-patient" basis in countries outside the United States.