PHILADELPHIA, May 10, 2004 (PRIMEZONE) -- Law Offices Bernard M. Gross, P.C. (http://www.bernardmgross.com) announces that a class action lawsuit was commenced in the United States District Court for the District of New Jersey, against defendants GENTA INC. ("Genta" or the "Company") (Nasdaq:GNTA) and Raymond P. Warrell, Jr., M.D. -- Chief Executive Officer and Chairman of the Board and Loretta M. Itri, M.D., on behalf of all persons who purchased Genta securities (Nasdaq:GNTA), between March 26, 2003 through and including May 3, 2004 (the "Class Period") seeking remedies under the Securities Exchange Act of 1934 (the "Exchange Act").
Genta is a pharmaceutical company which describes itself as "focused on delivering innovative products for the treatment of patients with cancer." Genasense is an oncology drug created by Genta which attempts to target directly the biochemical pathway whereby cancer cells are ultimately killed by chemotherapy.
The complaint alleges that, during the Class Period, defendants falsely represented to the investing public that Genasense did not appear to be associated with serious adverse reactions in the Phase 3 clinical trial. However, unknown to the public, the use of Genasense was associated with increased toxicity and discontinuations due to adverse events which seriously threatened FDA approval of the drug, particularly in light of the marginal benefits associated with the drug. By reason of the testing of Genasense, defendants knew or should have known of the following events: (a) 69 (18.6%) patients discontinued therapy for adverse events on the G3139 arm versus 39 (10.8%) on the DTIC arm alone; (b) the rate of serious adverse events was 40% on the G3139 arm versus 27% on DTIC alone; (c) all toxicities were more frequent on the Genasense arm; (d) the frequency of grade 3-4 adverse events, serious adverse events and treatment emergent adverse events leading to discontinuation were all higher on the Genasense arm; (e) the incidence of thrombocytopenia, a serious bleeding disorder characterized by a marked decrease in the number of blood platelets, was 28.8% in the Genasense arm, compared with 11.1% in the DTIC arm; (f) pyrexia (fever) was three times as frequent on the Genasense arm with 53.1% in the Genasense arm, compared to 17.5% on the DTIC arm; (g) neutropenia (significantly reduced white blood cells) and anorexia were twice as frequent with Genasense; (h) upper extremity thrombosis (blood clots) occurred in 5% of the patients receiving Genasense, compared with .8% of the patients receiving DTIC alone; (i) in the Genasense arm, 18.6% of patients discontinued treatment permanently, compared with 10.8% on the DTIC arm; and (j) since the dosing of DTIC was identical on the two arms, toxicity increases were due to the addition of G3139.
On September 10, 2003, Genta announced the results of the Phase 3 clinical study of Genasense and submitted the first portion of the NDA to the FDA. The NDA was completed on December 8, 2003 and on February 6, 2004, Genta announced that the FDA had accepted the NDA. In addition, Genta announced on February 6, 2004 that the FDA granted Priority Review status to the application. On April 30, 2004, the staff of the Oncologic Drugs Advisory Committee (ODAC) of the FDA stated in briefing materials in advance of the May 3, 2004 ODAC meeting that the Phase 3 clinical trial of Genasense failed to demonstrate a survival benefit, which was the primary trial endpoint. However, small but unreliable benefits were seen for progression-free survival (PFS) and response rates (RR). The staff also stated: "Uncertainty also exists regarding whether an improvement in PFS and RP of this magnitude outweighs the increase in toxicity seen with the combination (of Genasense and dacarbazine.): . . . Survival was not improved and toxicity was increased." As a result of this April 30th announcement, the price of Genta shares dropped $5.83 or 40.4% to close at $8.60 on the Nasdaq market on an unusually high volume of over 30 million shares traded. On May 3, 2004, the ODAC ruled by a 13-3 vote that, in the absence of increased survival, the evidence presented did not provide substantial evidence of effectiveness to outweigh the increased toxicity of Genasense. As a result of this announcement, the price of Genta shares fell more than $3 per share, to close at $5.11 on May 3, 2004 at a high volume of over 17 million shares traded. If you wish to discuss this action or have any questions concerning this notice or your rights or interests, please contact plaintiff's counsel, Deborah R. Gross or Susan R. Gross of Law Offices Bernard M. Gross at 866-561-3600(toll-free) or via e-mail at susang@bernardmgross.com. If you are a member of this class, you can view a copy of the complaint as filed at http://www.bernardmgross.com. Any member of the purported class may move the Court to serve as lead plaintiff through counsel of their choice, or may choose to do nothing and remain an absent class member.
If you purchased or otherwise acquired the securities of Genta, Inc. between March 26, 2003 through and May 3, 2004, and sustained damages, you may, no later than July 5, 2004, file a motion to be appointed lead plaintiff, if you so choose. Law Offices Bernard M. Gross, P.C. has significant experience and expertise in prosecuting class actions.
More information on this and other class actions can be found on the Class Action Newsline at www.primezone.com/ca