April 23, 2009 08:05 AM Eastern Daylight Time
Genta Announces Presentations for Two Lead Compounds, Genasense® and Tesetaxel, at 2009 Annual ASCO Meeting
BERKELEY HEIGHTS, N.J.--(BUSINESS WIRE)--Genta Incorporated (OTCBB: GNTA.OB) announced today that data from clinical trials of the Company's late-stage compounds, Genasense® (oblimersen sodium) Injection and tesetaxel, will be presented at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting. The meeting will be held from May 29- June 2, 2009 in Orlando, FL.
Genta has now completed enrollment into AGENDA, the second of two large randomized Phase 3 trials of Genasense plus dacarbazine chemotherapy in patients with advanced melanoma. In parallel, the Company has also sponsored a pilot dose-ranging study in advanced melanoma using Genasense combined with different chemotherapy, including Temodar® (temozolomide; Schering Plough, Inc.) plus Abraxane® (paclitaxel protein-bound particles for injectable suspension) [albumin bound]; Abraxis Oncology, Inc.). This trial employs a new brief intravenous infusion schedule for Genasense, as well as a biomarker for targeting patient selection similar to that employed in AGENDA. At ASCO, results of long-term survival from this pilot non-randomized trial will be reported.
Genta has also sponsored a clinical and pharmacokinetic study of tesetaxel, a leading oral taxane in clinical development, in patients with advanced cancer who were treated at doses up to and including the maximally tolerated dose. Prior trials have employed tesetaxel dosed according to height and weight parameters (i.e., milligrams of drug per square meter of body surface area) that are difficult to precisely administer in clinical practice using an oral drug. At ASCO, dosing and pharmacokinetic data based on conversion of tesetaxel from weight-based to flat dosing (e.g., a prescribed single dose of 50 mg) will be presented. Titles, dates and times of these presentations appear below.
Survival of advanced melanoma patients with normal LDH treated with oblimersen, temozolomide, and nab-paclitaxel. (Abstract #9080). Monday June 1, 2009. Poster Session: Melanoma/Skin Cancer: 8 am-12 pm.
Pharmacology and safety factors affecting use of flat (rather than weight-based) dosing of tesetaxel, an orally administered taxane. (Abstract #2510). Monday June 1, 2009. Poster Session: Developmental Therapeutics: 2-6 pm; Discussion Session: 5-6 pm.
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, that 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 marketing and reimbursement approvals for its products from the U.S. Food and Drug Administration (“FDA”) and other regulatory or governmental authorities;
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 and maintain license and collaborative agreements;
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.
Contacts
Genta Investor Relations
908-286-3980
info@genta.com
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