Genta Incorporated (OTCBB:GETA.OB) announced publication of a paper that independently confirms the link of a key biomarker to overall survival in patients with advanced melanoma. The biomarker, a tumor-derived enzyme known as lactate dehydrogenase (LDH), is measured by a widely available blood test. Genta�s recently completed Phase 3 trial of Genasense� in advanced melanoma, known as AGENDA, specified low-normal LDH as an enrollment criterion. Results for progression-free survival (PFS), a co-primary endpoint of AGENDA, are anticipated in the Fourth Quarter of this year. If positive, the AGENDA results are expected to support global regulatory applications for Genasense� in this indication.

A previous randomized Phase 3 trial compared outcomes of patients with advanced melanoma who were treated using standard chemotherapy (dacarbazine) with and without Genasense� (oblimersen sodium) Injection, the Company�s lead anticancer compound. This trial showed that overall survival (OS) was strongly associated with baseline levels of LDH. While high levels of LDH have long been associated with poor outcome in melanoma and other cancers, the Genasense study showed a significant interaction with treatment outcome in a prospectively stratified randomized trial. A scientific article that describes efficacy and safety results from that study can be accessed here: http://www.jco.org/cgi/content/abstract/JCO.2006.06.0483v1.

The new publication describes the statistical model that first elucidated an association between increasingly elevated levels of LDH and inferior OS in the previous trial, along with the prospective application of that model to data derived from a recent trial conducted by the European Organization for Research and Treatment of Cancer (EORTC), the largest European oncology cooperative group. The EORTC randomized patients with advanced melanoma to drug combinations that did not employ Genasense and showed no between-treatment differences. The investigators then aggregated data from their study to test the hypothesis generated in the Genasense trial: namely, that OS in advanced melanoma is inversely associated with increasingly elevated levels of LDH.

The new analysis from the EORTC trial confirmed that association and showed results that were highly congruent with observations from the Genasense study. Moreover, the EORTC analysis also confirmed that this association extended into the normal range: specifically, patients with low-normal LDH had extended survival, an observation first established in the Genasense study. Thus, the EORTC analysis provides strong and independent confirmation of the association between survival and LDH levels. The new information appears in the July issue of the European Journal of Cancer. An abstract of the publication can be viewed here: http://www.ejcancer.info/article/S0959-8049(09)00282-2/abstract.

About AGENDA

AGENDA is a Phase 3, randomized, double-blind, placebo-controlled trial that is intended to support global registration of Genasense for patients with advanced melanoma. The study is designed to confirm certain safety and efficacy results from Genta�s prior randomized trial of Genasense combined with dacarbazine in patients who have not previously received chemotherapy and who are identified by a biomarker (low-normal levels of LDH). The co-primary endpoints of AGENDA are PFS and OS. The trial has completed accrual of 315 patients. PFS results � a co-primary endpoint in this trial -- are anticipated in the Fourth Quarter of 2009.

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. Two major programs anchor the Company�s research platform: DNA/RNA-based Medicines and Small Molecules. Genasense� (oblimersen sodium) Injection is the Company's lead compound from its DNA/RNA Medicines program. The leading drug in Genta�s Small Molecule program is Ganite� (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, which has recently entered clinical trials as a potential treatment for diseases associated with accelerated bone loss. The Company is also developing tesetaxel, a novel, orally absorbed, semi-synthetic taxane that is in the same class of drugs as paclitaxel and docetaxel. Ganite and Genasense 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.

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. Such forward-looking statements include those that express plan, anticipation, intent, contingency, goals, targets, or future developments and/or otherwise are not statements of historical fact. The words �potentially�, �anticipate�, �could�, �calls for�, and similar expressions also identify forward-looking statements. The Company does not undertake to update any forward-looking statements. Factors that could affect actual results include, without limitation, risks associated with:

  • the Company�s ability to obtain necessary regulatory approval for Genasense� from the U.S. Food and Drug Administration (�FDA�);
  • 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, the Company�s ability to obtain sufficient financing to maintain the Company�s planned operations, or the Company�s risk of bankruptcy;
  • the adequacy of the Company�s patents and proprietary rights;
  • the impact of litigation that has been brought against the Company; 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.

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 2008 and its most recent quarterly report on Form 10-Q.