Healthcare Industry News: Ganite
News Release - November 29, 2006
Genta Initiates Pilot Clinical Trial of Genasense(R) Plus Abraxane(R) and Temodar(R) as First-Line Therapy for Patients with Advanced MelanomaStudy Will Evaluate Dosing Schedules, Safety and Activity of Promising Drug Combination
BERKELEY HEIGHTS, N.J., Nov. 29 (HSMN NewsFeed) -- Genta Incorporated (Nasdaq: GNTA ) announced that the Company has initiated a new clinical study that will evaluate the Company's lead anticancer drug, Genasense® (oblimersen sodium) Injection in patients with advanced melanoma. This trial is the first follow-on study to Genta's randomized Phase 3 trial of Genasense plus dacarbazine that showed benefit across multiple clinical endpoints in patients with advanced melanoma who had not previously received chemotherapy. The new study represents the rapid clinical translation of preclinical results that demonstrated marked anticancer synergy when Genasense was combined with Abraxane® (paclitaxel protein-bound particles; Abraxis Oncology, Inc.) and Temodar® (temozolomide; Schering Plough, Inc.). Both of these chemotherapy agents have recently entered Phase 3 clinical trials in patients with advanced melanoma.
The new pilot study will evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of the three-drug combination in chemotherapy-naive patients whom have normal levels of a key biomarker, serum lactate dehydrogenase (LDH). Several dosing schedules will be examined in order to develop a regimen that may optimize safety and efficacy for additional testing. The study will be led by Dr. Anna Pavlick, Director, NYU Melanoma Program, Assistant Professor of Medicine and Dermatology, New York University Cancer Institute, New York, NY.
The activity of this drug combination is supported by preclinical data that were presented earlier this month in Prague at the 18th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics. Information on this presentation can be accessed at: http://www.genta.com/Genta/InvestorRelation/2006/press_20061109.html. Results from the previous randomized trial of Genasense plus dacarbazine can be accessed at: http://www.jco.org/cgi/content/abstract/JCO.2006.06.0483v1.
"Our goal with this trial is to further evaluate the potential for Genasense to synergize with a taxane combined with temozolomide, drugs that are widely used in patients with advanced metastatic melanoma," commented Dr. Pavlick. "Genasense has demonstrated significant benefit in melanoma patients compared with dacarbazine chemotherapy used alone. We hope that this new combination may provide an enhanced level of anti-melanoma activity using a "patient friendly" regimen for patients who suffer with this devastating disease."
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.
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® (oblimersen sodium) Injection is the Company's lead compound from its oligonucleotide program. The Company has submitted a New Drug Application (NDA) to the Food and Drug Administration for the use of Genasense plus fludarabine and cyclophosphamide for treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Genta has also completed a Marketing Authorization Application to the European Medicines Agency (EMEA) for use of Genasense plus dacarbazine for treatment of 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. 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® 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; -- the Company's ability to regain 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 2005 and its most recent quarterly report on Form 10-Q.
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