Genta Clinical Programs Featured at American Society of Hematology MeetingPhase 3 CLL Survival Analysis Selected for ASH Press Briefing
BERKELEY HEIGHTS, N.J., December 04, 2007 /PRNewswire-FirstCall/ -- Genta Incorporated 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, as follows:
-- 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: 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 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 and any proposed settlement of such litigation; -- the Company's ability to retain 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 2006 and its most recent quarterly report on Form 10-Q.
CONTACT: Nichol Harber Genta Investor Relations Brian Korb The Trout Group email@example.com
CONTACT: Nichol Harber, Genta Investor Relations, ; or BrianKorb of The Trout Group, +1-908-286-3980 firstname.lastname@example.org
Web site: http://www.genta.com/
Ticker Symbol: (NASDAQ-NMS:GNTA)
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Posted: December 2007