Genasense(R) Shown Active Using Intermittent Dosing In Melanoma Preclinical Studies

Main Category: Melanoma / Skin Cancer
Also Included In: Clinical Trials / Drug Trials
Article Date: 10 Nov 2006 - 0:00 PDT

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Genta Incorporated (Nasdaq: GNTA) announced the presentation of new data related to the Company's research program in solid tumors. In preclinical models, high- dose intermittent treatment with Genasense was both efficacious and associated with increased uptake of the drug within tumors. The use of Genasense plus Abraxane(R) (paclitaxel protein-bound particles; Abraxis Oncology, Inc.) and Temodar(R) (temozolomide; Schering Plough, Inc.) also proved synergistic in a highly aggressive model of malignant melanoma. As shown in the figure, this triple combination showed extremely prolonged suppression of tumor growth. The data were presented today at the 18th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, Prague, Czech Republic. Both the intermittent dosing regimens, as well as certain of the drug combinations, are expected to be rapidly translated into clinical trials.

In this program, initial studies evaluated Genasense in several dosing schedules using xenograft models of human lung cancer, colon cancer and melanoma. Treatment every 3 days was demonstrably more effective than continuous daily dosing. Intravenous treatment as infrequently as twice per week was active and potentiated the activity of multiple kinase inhibitors (erlotinib, imatinib, sunitinib, and sorafenib) used either alone or in combination with a taxane. In all tumors, the combination of Genasense combined with a taxane and kinase inhibitor was highly effective, and regimens were identified that were well-tolerated during repeated cycles and maximized tumor suppression.

"In order to extend these observations, we have initiated a clinical trial to evaluate intermittent dosing of Genasense by both subcutaneous injection and brief intravenous infusion," said Dr. Bob D. Brown, Vice-President, Research and Technology. "From a clinical standpoint, our results using intermittent dosing may eventually obviate the current requirement for continuous IV infusion. These results together with the combination data in melanoma, and with various kinase inhibitors in multiple tumors, will facilitate our ongoing development of clinical regimens that are significantly more "patient friendly".

About Genasense

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.

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.

Safe Harbor

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's ability to obtain necessary regulatory approval for Genasense(R) from the U.S. Food and Drug Administration ("FDA") or European Medicines Agency ("EMEA");

- the safety and efficacy of the company's products or product candidates;

- the company's assessment of its clinical trials;

- the commencement and completion of clinical trials;

- the company's ability to develop, manufacture, license and sell its products or product candidates;

- the company's ability to enter into and successfully execute license and collaborative agreements, if any;

- the adequacy of the company's capital resources and cash flow projections, and the company's ability to obtain sufficient financing to maintain the company's planned operations;

- the adequacy of the company's patents and proprietary rights;

- the impact of litigation that has been brought against the company and its officers and directors;

- the Company's ability to regain compliance with the NASDAQ's listing qualifications; and

- the other risks described under Certain Risks and Uncertainties Related to the company's Business, as contained in the company's Annual Report on Form 10-K and Quarterly Report on Form 10-Q.

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 2005 and its most recent quarterly report on Form 10-Q.

Genta Incorporated
http://www.genta.com

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