Genta Cites Publication of Study Showing Improved Outcomes in CLL Patients Treated with Genasense Plus Chemotherapy
BERKELEY HEIGHTS, NJ – February 14, 2007 – Genta Incorporated (NASDAQ: GNTA) today announced the publication of findings from a Phase 3 trial of the Company’s lead anticancer drug, Genasense® (oblimersen sodium) Injection, when used in combination with chemotherapy for treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL). The findings were published on-line this week in the Journal of Clinical Oncology, ahead of its tentatively scheduled print publication date of March 20, 2007.
Conducted at 100 centers in the U.S., Europe, Canada, Australia and South America, patients with relapsed or refractory CLL received fludarabine plus cyclophosphamide (Flu/Cy) chemotherapy with or without Genasense. This trial — the first randomized study ever conducted in this population — achieved its primary endpoint, which was a statistically significant increase in the proportion of patients who achieved a complete or nodular partial response (CR/nPR) (17% vs. 7%; P=0.025).
Patients who achieved CR/nPR experienced the disappearance of all predefined CLL symptoms, including fever, night sweats, fatigue, abdominal discomfort due to an enlarged spleen, and impaired mobility due to swollen lymph nodes.
The key secondary endpoint — duration of CR/nPR — was also significantly longer for patients treated with Genasense (median = not reached but will exceed 36+ months in the Genasense group vs. 22 months for patients treated with chemotherapy alone).
Among patients who achieved a CR/nPR with Genasense, 70 percent were alive at three years versus 38 percent for the control arm. Among patients who achieved a partial response, 45 percent who received Genasense were alive at three years compared to 33 percent for the control arm.
The lead and senior authors of the article are, respectively, Dr. Susan O’Brien, Professor of Medicine, Department of Leukemia, M.D. Anderson Cancer Center, and Dr. Kanti R. Rai, Chief, Hematology and Oncology, North Shore/Long Island Jewish Medical Center, and Professor of Medicine, Albert Einstein College of Medicine. An abstract of this article that addresses safety and efficacy in the trial can be accessed at: http://www.jco.org/cgi/content/abstract/JCO.2006.07.1191v1.
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. Genta has completed a pending 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.
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;
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• 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. SOURCE: Genta Incorporated
Posted: February 2007