Healthcare Industry News: Ganite
News Release - January 24, 2006
Subcutaneous Genasense(R) Trial Initiated in Patients with Solid TumorsNew Route of Administration May Extend Potential Utility and Increase Patient Convenience
BERKELEY HEIGHTS, N.J., Jan. 24 (HSMN NewsFeed) -- Genta Incorporated (Nasdaq: GNTA ) announced that the first patient has been entered into a new clinical study that will evaluate the bioactivity and safety of the company's lead anticancer drug, Genasense®(oblimersen sodium) Injection, administered by intermittent subcutaneous injection. The study employs a new formulation of Genasense that is five-fold more concentrated than material currently used in clinical trials. Having completed requisite animal toxicology work, the trial is proceeding pursuant to a separate Investigational New Drug (IND) application that was filed with the U.S. Food and Drug Administration. The new development program will evaluate a range of single doses, followed by repeated dosing schedules, in order to optimize use for future studies. The initial clinical trial is being led by Dr. Anthony Tolcher from the Institute for Drug Development and the University of Texas Health Sciences Center at San Antonio.
Genasense inhibits production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced cell death. By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current anticancer treatment. Recent Phase 3 studies of Genasense combined with chemotherapy have administered the drug by continuous intravenous infusion (CIV). However, a prolonged subcutaneous infusion method using the existing IV formulation was studied in patients with advanced non-Hodgkin's lymphoma, which showed antitumor activity as a single agent and documented down-regulation of Bcl-2 (J Clin Oncol. 18:1812, 2000). The new program seeks to extend these initial observations in a formal dose-ranging trial using the new, highly concentrated formulation.
"If successful, intermittent subcutaneous injections may prove highly desirable for a new generation of clinical studies," commented Dr. Raymond P. Warrell, Jr., Genta's Chairman and Chief Executive Officer. "Genasense has demonstrated synergy with various treatments, such as Tarceva® (erlotinib), interferon and radiation, all of which require multi-day schedules. The new method may substantially increase patient convenience and expand the utility of Genasense, particularly in front-line and adjuvant settings."
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 recently submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for the use of Genasense plus fludarabine and cyclophosphamide for treatment of patients with relapsed or refractory chronic lymphocytic leukemia. 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 patients with cancer related hypercalcemia that is resistant to hydration. For more information about Genta, please visit our website at: http://www.genta.com.
This press release contains 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. 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/Form 10-K for 2004.
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