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12.01.2009 13:05

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Genta Updates Late-Stage Progress of Its Phase 3 Trial of Genasense® in Advanced Melanoma

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Genta Incorporated (OTCBB: GNTA) announced the presentation of a progress update on the Company’s ongoing Phase 3 trial of Genasense® (oblimersen sodium) Injection, Genta’s lead oncology product, in patients with advanced melanoma. The data were presented in conjunction with the 27th Annual JP Morgan Healthcare Conference in San Francisco, CA.

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 (DTIC) in patients who have not previously received chemotherapy and who are identified by a biomarker (low-normal levels of lactate dehydrogenase [LDH]). The co-primary endpoints of AGENDA are progression-free survival (PFS) and overall survival. The trial is being led by the EADO in Europe and by the M.D. Anderson Cancer Center, Houston, TX in the U.S.

To date, more than three-quarters of the expected total number of 300 patients have been randomized into AGENDA. A total of 77 sites in 12 countries are open in Europe, the U.S., Canada, and Australia. As shown in the tables below, updated preliminary information on patient characteristics and safety findings in approximately two-thirds of patients accrued to AGENDA are similar to those in the biomarker-defined population that was accrued in the previous Phase 3 trial of Genasense, known as GM301. The incidence of serious adverse events (SAEs) in AGENDA has been somewhat lower, which may reflect the double-blind design of AGENDA compared with the open-label design of GM301.

"We have made very substantial progress in accrual and have noted similar patient demographics in the completed and ongoing trials”, said Dr. Loretta M. Itri, Genta’s President Pharmaceutical Development, and Chief Medical Officer. "Overall data from patients in these two populations, who are not identified as to treatment assignment, also show good congruence to date for the number and timing of progression events, which are key components in the PFS co-primary endpoint. We are grateful for the excellent support we have received from the investigator community and look forward to the timely completion of target accrual later this quarter.”

Demographic Comparison of Combined Blinded Demographic Data

     
Demographic Factor   GM301 (low-normal LDH)

N=274

    AGENDA (low-normal LDH)

N=208

Age, median (years) 60 58
Gender (M/F) (%) 64/36 64/36
Disease site(s): (%)
Skin, soft tissue, lymph nodes 22 25
Liver metastases 21 26
Other visceral metastases   57     49
       

Comparison of Combined Blinded Safety Data

 
Treatment-Related SAEs     GM301 (low-normal LDH)

N=259

Percent

    AGENDA (low-normal LDH)

N=212

Percent

Total SAEs 14 10
Thrombocytopenia 4 3
Neutropenia 3 < 1
Anemia 2 < 1
Bacteremia/septicemia 1 < 1
Pneumonia 0 < 1
Pyrexia 4 < 1
Nausea     2     0

About AGENDA

AGENDA is a global Phase 3, randomized, double-blind trial in patients with advanced melanoma. The study is designed to confirm certain safety and efficacy results from an antecedent randomized trial of Genasense combined with dacarbazine (DTIC) in patients who have not previously received chemotherapy (GM301). AGENDA employs a biomarker to define those patients who derived maximum clinical benefit during the preceding study. These patients are characterized by low-normal levels of LDH (lactate dehydrogenase), a tumor-derived enzyme that is readily detected in blood. Analysis of those efficacy outcomes in GM301, which were observed in 274 patients, showed the following results:

       

Endpoint

 

Genasense/DTIC

 

DTIC

  Hazard

Ratio

 

P

Overall response 20.8% 7.2% 0.002
Durable response 10.7% 2.4% 0.007
Progression-free survival, median 3.6 mos. 1.6 mos. 0.58 < 0.0001
Overall survival, median   12.3 mos.   9.9 mos.   0.64   0.0009

A scientific article that describes efficacy and safety results from GM301 can be accessed at: http://www.jco.org/cgi/content/abstract/JCO.2006.06.0483v1

About the EADO

The EADO is an independent non-profit organization dedicated to promote, coordinate and improve clinical and laboratory research activities in the field of skin cancer. The organization has a European and international membership of dermatologists, oncologists and clinical as well as basic research scientists interested in the field of dermato-oncology. EADO provides leadership by formulating and disseminating quality standards and guide-lines for diagnosis and treatment of skin cancer, and it provides direction, coordination and organizations of clinical, therapeutic, and experimental trials.

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. 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. 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® (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 approvals for Genasense® or its other 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 2007 and its most recent quarterly report on Form 10-Q.

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