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Genta Receives Special Protocol Assessment from FDA for Confirmatory Trial of Genasense(R) Plus Chemotherapy in Chronic Lymphocytic Leukemia |
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26 Jul 2006 |
BERKELEY HEIGHTS, NJ, USA | July 26, 2006 | Genta Incorporated (Nasdaq: GNTA) announced that the Company's proposal for a confirmatory trial of Genasense(R) (oblimersen sodium) Injection in patients with chronic lymphocytic leukemia (CLL) has completed Special Protocol Assessment (SPA) by the Food and Drug Administration (FDA). The SPA documents FDA's agreement regarding the trial's design and planned analyses to fulfill commitments that may be required under provisions related to SubPart H regulations regarding accelerated approval. Genta has filed a New Drug Application (NDA) under SubPart H for Genasense plus chemotherapy, which is currently under review by FDA. The NDA has a target action date for a marketing approval decision by October 29, 2006 under the Prescription Drug User Fee Act (PDUFA).
The trial, which will be conducted in symptomatic patients who have not previously received chemotherapy, will randomize patients to receive fludarabine plus rituximab (Rituxan(R); Genentech, Inc.) with or without Genasense. The pivotal trial in the pending NDA employed a combination of fludarabine plus cyclophosphamide with or without Genasense in patients with relapsed or refractory CLL.
"Data from our previous randomized trials have suggested that extensive prior treatment may introduce other mechanisms of acquired drug resistance," said Dr. Loretta M. Itri, Genta's Chief Medical Officer and President, Pharmaceutical Development. "This study targets treatment-naïve patients with a regimen that is still considered investigational, but which includes the most widely prescribed drugs for CLL in the U.S. With this trial, we reaffirm our commitment to patients with this illness, and we are very pleased with FDA's review of this next-step proposal."
About Genta
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. The Company's research platform is anchored by two major programs that center on oligonucleotides (RNA- and DNA- based medicines) and small molecules. Genasense(R) (oblimersen sodium) Injection is the Company's lead compound from its oligonucleotide program.
The Company has submitted a New Drug Application (NDA) to the Food and Drug Administration for the use of Genasense plus fludarabine and cyclophosphamide for treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Genta has also completed a Marketing Authorization Application to the European Medicines Agency (EMEA) for use of Genasense plus dacarbazine for treatment of 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.
For more information about Genta, please visit our website at: http://www.genta.com.
SOURCE Genta Incorporated |
