Phase 3 CLL Survival Analysis Selected for ASH Press Briefing
BERKELEY HEIGHTS, N.J., Dec. 4 /PRNewswire-FirstCall/ -- Genta
Incorporated (Nasdaq: GNTA) announced that several abstracts related to the
Company's clinical programs will be featured at the annual meeting of the
American Society of Hematology (ASH) in Atlanta, GA during December 7-11,
2007. Programs involving Genasense(R) (oblimersen sodium) Injection,
Genta's lead anticancer compound, and G4544, a new oral drug for bone
diseases, were released in abstracts published in the meeting proceedings,
-- Addition of oblimersen (Bcl-2 antisense) to
fludarabine/cyclophosphamide for relapsed/refractory chronic
lymphocytic leukemia extends survival in patients who achieve CR/nPR:
Results from a randomized Phase 3 study.
Oral session: Tuesday, December 11, 2007; 7:30 am
Note: This abstract has been selected for a featured press briefing
sponsored by ASH on Sunday December 9 at 9:30 am.
-- Oblimersen (Genasense(R)), a phosphorothioate Bcl-2 antisense
oligonucleotide (ASO), can be safely administered by bolus subcutaneous
(SC) injection and brief IV Infusion. Publication.
-- Phase 1 assessment of G4544, an orally bioavailable formulation of
gallium nitrate. Publication.
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.
G4544 contains the active ingredient in Genta's marketed compound, Ganite(R). Experimental work has established that low doses of Ganite directly inhibit calcium release from bone, principally by decreasing bone resorption and possibly by also stimulating bone formation. In patients with cancer-related hypercalcemia who were resistant to hydration, randomized double-blind trials have been conducted with Ganite compared with calcitonin and with two bisphosphonates (etidronate [Didronel(R); Proctor and Gamble] and pamidronate [Aredia(R); Novartis, Inc.]).
G4544 was developed to enable extended administration of the active ingredient in Ganite, which may greatly improve patient convenience and avoid the current need for intravenous pumps or hospitalization. The initial focus of clinical studies with G4544 will be to evaluate bioequivalence with the intravenous product, potentially enabling rapid regulatory approval of the oral formulation. Genta holds or has exclusively licensed the intellectual property related to G4544.
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(R) (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(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. The Company has developed G4544, an oral formulation of the active ingredient in Ganite, that has recently entered clinical trials as a potential treatment for diseases associated with accelerated bone loss. 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,
-- 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 Company's ability to retain compliance with the NASDAQ's listing
-- 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.
Genta Investor Relations
The Trout Group
|SOURCE Genta Incorporated|
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