| Company: | Genta Inc. |
| Ticker Symbol: | NASD: GNTA |
| Class Period: | September 10, 2003 to May 3, 2004 |
| Court: | District, NJ |
| Date Filed: | May-11-04 |
| Lead Plaintiff Deadline: | Jul-06-04 |
| Allegations: |
A Class Action lawsuit has commenced in the United States District Court for the District of New Jersey on behalf of all purchasers of securities of Genta Inc. ("Genta" or the "Company") (Nasdaq:GNTA) between September 10, 2003 and May 3, 2004, inclusive (the "Class Period").
The Complaint alleges that defendants violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, and Rule 10b-5 promulgated thereunder. The Complaint names as defendants Genta Inc., Raymond P. Warrell, Jr. and Loretta M. Itri. 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 acquired the securities of the defendants during the Class Period you may, no later than the Lead Plaintiff Deadline shown above, request that the Court appoint you as lead plaintiff through counsel of your choice. You may also choose to remain an absent class member. A lead plaintiff must meet certain requirements.
The Complaint alleges that defendants violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, and Rule 10b-5 promulgated thereunder. The Complaint names as defendants Genta Inc., Raymond P. Warrell, Jr. and Loretta M. Itri. 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 acquired the securities of the defendants during the Class Period you may, no later than the Lead Plaintiff Deadline shown above, request that the Court appoint you as lead plaintiff through counsel of your choice. You may also choose to remain an absent class member. A lead plaintiff must meet certain requirements.
If you feel you qualify for damages or remedies that might be awarded in this class action please fill in our form on the right to submit your complaint.
If your injustice does not match the complaint described above, please use this form to register your complaint. Thank you.
