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Genasense(R) Can be Administered by Brief High-Dose IV Infusion
Date:10/23/2007

p>In the trial presented today, escalating doses of Genasense ranging from 300 mg to 1,100 mg given over 1 to 2 hours were administered once per week to patients with advanced solid tumors. The maximally tolerated dose on this schedule was 900 mg, with limiting reactions that included fever, chills, and transient reduction in blood pressure. Further dose escalation (up to and including 1,100 mg) has been possible using premedication with a steroid and ibuprofen that reduce constitutional symptoms. By comparison, the highest dose used in Phase 3 trials of Genasense has been 20 mg/hr, which has been given as a continuous IV infusion for up to 7 consecutive days.

"This study is remarkable since it overturns more than a decade of preconceived safety notions based on animal toxicology that we now show was highly misleading," said Dr. Tolcher, who further noted: "More patients have received Genasense than all other DNA- or RNA-based medicines combined. Our data show that new schedules of Genasense can be readily developed that do not involve indwelling catheters or protracted IV infusions. These schedules should also facilitate the use of Genasense combined with many different drugs that are used on virtually any schedule. Going forward, we plan to evaluate Bcl-2 down-regulation using Genasense given on a twice-per-week schedule for 3 weeks, as well as further dose-escalation using premedication on the single- dose weekly schedule."

About Genasense

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.

About Genta

Genta Incorporated is a biopharmaceutical company with a diversified product portfolio t
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SOURCE Genta Incorporated
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