NEW YORK, June 12, 2004 (PRIMEZONE) -- A class action complaint has been filed in the United States District Court for the District of New Jersey, on behalf of all persons or entities who purchased or otherwise acquired Genta Inc. ("Genta" or the "Company") securities (Nasdaq:GNTA) between March 26, 2001 through May 3, 2004, inclusive (the "Class Period"). The Complaint names Raymond P. Warrell Jr., Loretta M. Itri, and the Company as defendants.
To discuss this action, this announcement, or your rights or interests, please contact plaintiff's counsel, Eric J. Belfi or Aaron Patton at Murray, Frank & Sailer LLP, 275 Madison Avenue, Suite 801, New York, NY 10016, by telephone at (800) 497-8076 or (212) 682-1818, by facsimile at (212) 682-1892, or by e-mail at info@murrayfrank.com.
The Complaint alleges that defendants violated section 10(b) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the Securities and Exchange Commission. In particular, the Complaint alleges that defendants failed to disclose and/or misrepresented the following adverse facts, among others: (1) that most patients enrolled in the Genasense Phase III study were asymptomatic and that 56% were "ECOG performance status 0" (fully active, able to carry on all pre-disease performance without restriction) at baseline; (2) that attempts to stratify and balance prognostic factors during the randomization of patients were unsuccessful, resulting in imbalances, including fewer patients with visceral disease-lactate dehydrogenase elevations (59% versus 67% in the DTIC alone arm); (3) that the majority of patients in both arms went off study after 6 weeks (two cycles) because of progressive disease; (4) that the study failed to show a survival benefit from the combination of Genasense plus DTIC using an unadjusted log rank analysis of survival time for the intention-to-treat population (p = 0.18, HR=0.89); (5) that as a result of "missing data," defendants employed a censoring procedure of "last observation carried forward" for analysis of secondary endpoints, to show a statistically significant benefit in progression-free survival; (6) that as a result of "missing data" and the questionable manner in which defendants arrived at their analysis of the secondary endpoints, defendants were required to perform a different procedure of censoring at last observation for missing data; (7) that as a result of these analyses and further simulations conducted by FDA reviewers, it was clear that defendants' study was biased and fundamentally flawed -- flaws which make it impossible to rule out that the statistically significant differences observed by defendants were false positive; (8) that of the 5 complete responses reported to the FDA by defendants, none were verified by their blinded, independent review organization; (9) that for all 71 responders identified by defendants, there was concordance with their blinded, independent review organization for only 49% of the interpretations; (10) that since most patients were asymptomatic at study entry and were performance status zero, it was difficult to assess whether patients achieved any symptom benefit from combination therapy over single-agent therapy; (11) that the addition of Genasense correlated with serious and alarming toxicity to patients during the study, including increased toxicity and discontinuations due to adverse events, including 69 patients (18.6%) who discontinued therapy for adverse events on the Genasense arm versus 39 (10.8%) on the DTIC alone arm; (12) that the rate of serious adverse events was 40% on the Genasense arm versus 27% on DTIC alone; (13) that since the dosing of DTIC was identical on the two arms, toxicity increases were likely due to the addition of Genasense; (14) that at the May 3, 2004 meeting of the ODAC, FDA would provide an accurate and transparent report of the concealed facts; (15) that the FDA and the ODAC had previously rejected an application that sought approval based on facts similar to those concealed by defendants, and specifically small differences in progression-free survival, a situation worsened in the case of Genasense as a result of the unreliable nature of the clinical data and the observation of serious toxicities cased by Genasense when used in combination with DTIC; and (16) that FDA regulations require "substantial evidence of efficacy" for any NDA, including NDA 21-649, and that no such finding could be made for Genasense since survival was not improved and toxicity was increased over the existing therapy.
On April 30, 2004, Genta announced that the FDA had posted on its website briefing documents for the ODAC meeting on Monday, May 3, 2004. The briefing documents suggested that Genasense will fail to win FDA approval. News of this shocked the market. Shares of Genta fell $5.83 per share or 40% on April 30, 2004 to close at $8.60 per share. In fact, on May 3, 2004, Genta failed to win FDA Panel support for Genasense. News of this sent shares of Genta falling another $3.49 per share or 40.5% to close at $5.11 on May 3, 2004.
Plaintiff is represented by the law firm of Murray, Frank & Sailer LLP. Murray, Frank & Sailer LLP and its predecessor firms have devoted its practice to shareholder class actions and complex commercial litigation for more than thirty years and have recovered hundreds of millions of dollars for shareholders in class actions throughout the United States.
If you purchased or otherwise acquired Genta securities during the Class Period between March 26, 2001 through May 3, 2004, you may, no later than July 5, 2004, move the Court to serve as lead plaintiff. To serve as lead plaintiff, however, you must meet certain legal requirements. You can join this action as a lead plaintiff online at http://www.murrayfrank.com/newcases_202.htm. Contact plaintiff's counsel Eric J. Belfi or Aaron Patton at Murray, Frank & Sailer LLP to further discuss this action, this announcement, or your rights or interests.
More information on this and other class actions can be found on the Class Action Newsline at www.primezone.com/ca