FDA Extends Review Period for Correction of Genasense Data- Genta Incorporated
BERKELEY HEIGHTS, N.J., Dec. 21 /PRNewswire-FirstCall/ -- Genta Incorporated announced today that the Company has received notice from the Food and Drug Administration (FDA) that FDA has extended its review period of Genta's request for correction of certain information that was filed pursuant to the Information Quality Act for an additional 60 days. The requested correction relates to FDA's assessment of progression-free survival (PFS) in the Phase 3 trial of Genasense(R) (oblimersen sodium injection) that was presented to the Oncology Drug Advisory Committee (ODAC) that considered Genta's New Drug Application for Genasense in patients with advanced melanoma.
"Melanoma is a key indication in our current Phase 3 development program", said Dr. Loretta M. Itri, M.D., Genta's President for Pharmaceutical Development and Chief Medical Officer. "A methodological error may have impacted ODAC deliberations, which voted unanimously that an improvement in PFS of some magnitude represents clinical benefit that could support regular approval in advanced melanoma."
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. For more information about Genta, please visit our website at: www.genta.com.
This press release may contain forward-looking statements with respect to business conducted by Genta Incorporated. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Forward- looking statements include, without limitation, statements about:
The Company does not undertake to update any forward-looking statements. There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the Company's Annual Report on Form 10-K for 2006 and its most recent quarterly report on Form 10-Q.