BERKELEY HEIGHTS, N.J., Aug. 7 /PRNewswire-FirstCall/ -- Genta Incorporated (OTC Bulletin Board: GNTA) today announced financial results for the quarter ended June 30, 2008. The Company recorded significant milestones in the second quarter, including the following:
-- NDA amendment for Genasense(R) in CLL submitted to FDA
-- AGENDA Phase 3 trial of Genasense in melanoma updated at EADO
-- Clinical hold on tesetaxel, a leading, clinical-stage oral taxane,
lifted by FDA
-- Pharmacokinetics of oral G4544 for bone disease presented at ASCO
-- Company closes $20 million financing in convertible notes
"Genta has three high-value clinical-stage products, and we have now secured funding that should enable us to conclude both our NDA amendment for Genasense(R) in CLL, as well as enrollment into our Phase 3 program in melanoma," said Dr. Raymond P. Warrell, Jr., Genta's Chairman and Chief Executive Officer. "FDA has targeted December 3, 2008 as the action date for the CLL NDA amendment, and we expect to report AGENDA results in melanoma during 2009. In response to Genta's regulatory submission, FDA has now lifted the clinical hold on tesetaxel, which will allow us to resume clinical trials with a leading oral taxane that addresses a large, well-characterized market. Our portfolio includes unique compounds that offer significant revenue and partnering opportunities."
Highlights of the Genta programs appear below.
Genasense: The Leading Antisense Drug in Clinical Development
Genasense in Melanoma: Genta is currently enrolling patients with
advanced melanoma in a Phase 3 trial of Genasense plus chemotherapy, known
as AGENDA. AGENDA is a randomized, double-blind, placebo-controlled trial
that is intended to support global registration of Genasense for patients
with advanced melanoma. The study is designed to confirm certain safety and
efficacy results from Genta's prior randomized trial of Genasense combined
|SOURCE Genta Incorporated|
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