UNITED STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT
REPORT PURSUANT
TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): December 3, 2004
GENTA
INCORPORATED
(Exact Name of Registrant
as Specified in Its Charter)
Delaware
(State or Other Jurisdiction of Incorporation)
| 0-19635 | 33-0326866 | ||
| (Commission File Number) | (IRS Employer Identification No.) | ||
| Two
Connell Drive Berkeley Heights, NJ |
07922 | ||
| (Address of Principal Executive Offices) | (Zip Code) |
(908) 286-9800
(Registrant’s
Telephone Number, Including Area Code)
(Former Name or
Former Address, if Changed Since Last Report)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy
the filing obligation of the Registrant under any of the following provisions:
| o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| o | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 8.01 Other
Events.
On December
3, 2004 Genta Incorporated (“Genta”) issued a press release announcing
that it has acquired world-wide rights from Temple University to intellectual
property and technology, and a novel antisense compound (LR3001) that targets c- myb,
a central gene that regulates the growth of cancer cells. The press release is
attached hereto as Exhibit 99.1 and incorporated herein by reference.
On December 4,
2004 Genta issued a press release announcing results from the Company’s
randomized Phase 3 clinical trial of Genasense® (oblimersen sodium) Injection in
patients with relapsed or refractory multiple myeloma were presented today at
the annual meeting of the American Society of Hematology (ASH) in San Diego, CA.
The press release is attached hereto as Exhibit 99.2 and incorporated herein by
reference.
On December 4,
2004 Genta issued a press release announcing that results have been reported from two
clinical studies using Genasense® (oblimersen sodium) Injection, the Company’s
lead anticancer compound, in combination with other drugs in patients with acute
myeloid leukemia (AML). A Phase 2 trial of Genasense® plus Mylotarg® (gemtuzumab
ozogamicin; Wyeth) showed that the combination could induce complete remissions
(CR) in patients with AML who had relapsed from extensive prior therapy. The second
trial correlated certain biomarkers with clinical response to Genasense® plus
standard chemotherapy in older patients. The press release is attached hereto as
Exhibit 99.3 and incorporated herein by reference.
On December
5, 2004 Genta issued a press release announcing that several presentations at the
annual meeting of the American Society of Hematology (ASH) featured use of the
Company’s lead anticancer drug, Genasense® (oblimersen sodium) Injection,
in patients with blood cancers that involve plasma cells. The press release is
attached hereto as Exhibit 99.4 and incorporated herein by reference.
On December
5, 2004 Genta issued a press release announcing that two new studies have shown
that Genasense® (oblimersen sodium) Injection, the Company’s lead
anticancer drug, showed synergistic activity with both bortezomib (Velcade®;
Millennium Pharmaceuticals, Inc.) and rituximab (Rituxan®; Genentech, Idec) in
experimental models of B-cell non-Hodgkin’s lymphoma (NHL). The data were
presented this weekend in sessions at the annual meeting of the American Society of
Hematology (ASH). The press release is attached hereto as Exhibit 99.5 and
incorporated herein by reference.
On December 5,
2004 Genta issued a press release announcing that results from a large Phase 2 trial
of Ganite® (gallium nitrate injection) in patients with advanced non-Hodgkin’s
lymphoma (NHL) were presented at the annual meeting of the American Society of
Hematology (ASH). The results showed that Ganite® displayed activity in a wide
variety of patients with various subtypes of advanced NHL who had failed to
respond or had relapsed from other types of treatment. The press release is
attached hereto as Exhibit 99.6 and incorporated herein by reference.
On December 6,
2004 Genta issued a press release announcing that results from the Company’s
randomized Phase 3 clinical trial of Genasense® (oblimersen sodium) Injection
in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) were
presented today at the annual meeting of the American Society of Hematology (ASH).
The trial showed that the addition of Genasense® significantly increased the
proportion of patients who achieved a major response, which was the primary
end-point of the trial. The press release is attached hereto as Exhibit 99.7 and
incorporated herein by reference.
| Exhibit Number |
Description | |
| |
|
|
| 99.1 | Press Release dated December 3, 2004 | |
| 99.2 | Press Release dated December 4, 2004 | |
| 99.3 | Press Release dated December 4, 2004 | |
| 99.4 | Press Release dated December 5, 2004 | |
| 99.5 | Press Release dated December 5, 2004 | |
| 99.6 | Press Release dated December 5, 2004 | |
| 99.7 | Press Release dated December 6, 2004 |
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned hereunto duly
authorized.
| GENTA INCORPORATED | ||||
| Date: | December 6, 2004 | By: | /s/ William P. Keane | |
| |
|
|||
| Name: |
William P. Keane | |||
| Title: | Vice President, Chief Financial Officer and Corporate Secretary | |||
EXHIBIT INDEX
| Exhibit Number |
Description |
Sequentially Numbered Page |
|
| 99.1 | Press Release dated December 3, 2004 | ||
| 99.2 | Press Release dated December 4, 2004 | ||
| 99.3 | Press Release dated December 4, 2004 | ||
| 99.4 | Press Release dated December 5, 2004 | ||
| 99.5 | Press Release dated December 5, 2004 | ||
| 99.6 | Press Release dated December 5, 2004 | ||
| 99.7 | Press Release dated December 6, 2004 |