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news.Genta Incorporated has entered the first patient into a new clinical study that will evaluate the bioactivity and safety of the company's lead anticancer drug, Genasense Injection, administered by intermittent subcutaneous injection.
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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 application that was filed with the FDA.
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.
A prolonged subcutaneous infusion method using the existing intravenous formulation of the drug has been studied in patients with advanced non-Hodgkin’s lymphoma. In this study the drug showed anti-tumor activity as a single agent and documented down-regulation of Bcl-2.
The new program seeks to extend these initial observations in a formal dose-ranging trial using the new, highly concentrated formulation.
“Genasense has demonstrated synergy with various treatments, such as Tarceva, interferon and radiation, all of which require multi-day schedules,” commented Dr Raymond Warrell, Genta’s chairman and CEO. “The new method may substantially increase patient convenience and expand the utility of Genasense, particularly in front-line and adjuvant settings.”