Barcelona Hosts Key Investigator Meeting for European Participants in Phase
3 AGENDA Trial Targeting Biomarker-Defined Population
BERKELEY HEIGHTS, N.J., Sept. 5 /PRNewswire-FirstCall/ - Genta Incorporated (Nasdaq: GNTA) announced that data from the Company's Phase 3 trial of Genasense(R) (oblimersen sodium) plus chemotherapy would be presented at the opening session of the first Worldwide Melanoma Center Meeting organized by the European Association of Dermato-Oncology (EADO). Genta, which is a Silver Level sponsor of the EADO meeting, will also host its key investigator meeting for European participants in the Company's ongoing Phase 3 trial of Genasense in advanced melanoma. The Genasense clinical results will be presented by Dr. Claus Garbe, who is Chair of the Congress, and Professor of Dermatology and Head of the Division of Dermatooncology, Department of Dermatology, University Medical Center, Tubingen, Germany. The EADO, which is the lead international cooperative group for the current Phase 3 trial, is meeting this week in Barcelona, Spain.
The new Genasense trial, known as AGENDA, is a randomized, double-blind, placebo-controlled study in which patients are randomly assigned to receive Genasense plus dacarbazine (DTIC) or DTIC alone. AGENDA is designed to confirm the safety and efficacy of Genasense when combined with DTIC in patients who have not previously received chemotherapy. The trial will accrue approximately 300 patients who have been defined using a biomarker and will be conducted at approximately 100 sites worldwide, including North America, Europe and Australia. Patient enrollment into AGENDA has been initiated.
About Genasense in Advanced Melanoma
Genasense, Genta's lead anticancer drug, is a novel targeted therapy that blocks the production of Bcl-2, a protein that appears to be a fundamental cause of cancer treatment resistance. By knocking down Bcl-2, Genasense may enhance the effectiveness of chemotherapy in patients with advanced melanoma. Genasense in melanoma has Orphan Drug designations in Australia and the U.S., along with Fast Track designation in the U.S.
In its initial Phase 3 trial, Genta performed the largest randomized controlled trial that has ever been conducted in patients with advanced melanoma. In that trial, 771 patients were randomly assigned to receive chemotherapy with DTIC alone or in combination with Genasense. A scientific article that describes efficacy and safety results from this study can be accessed at: http://www.jco.org/cgi/content/abstract/JCO.2006.06.0483v1.
In that trial, patients were prospectively stratified according to levels of a blood enzyme known as LDH. Further analysis of this study showed that maximum benefit accrued to patients whose LDH biomarker did not exceed 80% of the upper limit of normal. Efficacy results in this group of 274 patients, which are the focus of the confirmatory AGENDA trial, are displayed in the table below. (The hazard ratios indicate that the addition of Genasense to DTIC was associated with a 42% reduction in the risk of disease progression and a 36% reduction in risk of death.)
Endpoint Genasense/DTIC DTIC Hazard P
Overall response 20.8 % 7.2 % 0.002
Durable response 10.7 % 2.4 % 0.007
median 3.6 mos. 1.6 mos. 0.58 <0.0001
Overall survival, median 12.3 mos. 9.9 mos. 0.64 0.0009
Malignant melanoma is the most deadly form of skin cancer. The incidence of this disease is increasing by approximately 4% annually in the U.S. In 2004, the American Cancer Society estimates more than 55,000 cases of malignant melanoma will have been diagnosed. Melanoma is the number one cause of cancer death in women aged 25 to 29. More information about melanoma can be accessed at the Melanoma Research Foundation: http://www.melanoma.org.
About the EADO
The EADO is an international cooperative group dedicated to promote, coordinate and improve clinical and laboratory research activities in skin cancer. Further information about the EADO can be viewed at: http://www.eado.org/.
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 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. Genta is partnered with IDIS (http://www.idispharma.com) on a program whereby both 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: http://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'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
-- 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 and any proposed settlement of such
-- 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 2006 and its most recent quarterly report on Form 10-Q.
For Genta Incorporated
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