Genta Submits NDA Amendment to FDA for Genasense as Treatment of Chronic Lymphocytic...

Genta Submits NDA Amendment to FDA for Genasense as Treatment of Chronic
Lymphocytic Leukemia
Submission Based on Increased 5-Year Survival Data for Responding Patients

BERKELEY HEIGHTS, N.J., June 6 /PRNewswire-FirstCall/ -- Genta
Incorporated (OTC Bulletin Board: GNTA) announced that the Company has
submitted an amendment to the Food and Drug Administration (FDA) for its New
Drug Application (NDA) for Genasense(R) (oblimersen sodium) Injection plus
chemotherapy for patients with relapsed or refractory chronic lymphocytic
leukemia (CLL). The submission is based on new information from the Company's
completed Phase 3 trial that showed, among other findings, a significant
increase in overall survival for patients who achieved a complete or partial
response when treated with Genasense plus chemotherapy compared with patients
treated with chemotherapy alone. The data were presented at an oral session
at the annual meeting of the American Society of Clinical Oncology (ASCO) in
Chicago on Monday June 2, 2008.
Genta was notified in March 2008 that its appeal of a "non-approvable"
decision for the Genasense NDA had been denied by FDA's Center for Drug
Evaluation and Research (CDER). However, that decision described a regulatory
path forward that included but was not limited to determination of long-term
survival in patients who entered the study. The Company believes its
submission comprises a "complete response" to FDA's decision. At this time,
the Company cannot provide guidance regarding the expected duration of FDA
review of this amendment.
"We are pleased that the FDA will consider this new information, and we
look forward to working with FDA staff during their review of this amendment
to our NDA," commented Dr. Loretta M. Itri, Genta's President, Pharmaceutical
Development, and Chief Medical Officer.
About Chronic Lymphocytic Leukemia
CLL is the most common form of leukemia in adults. According to the
American Cancer Society, approximately 8,000 patients will be diagnosed this
year. More than 60,000 people in the U.S. currently have CLL. The disease
arises in lymphocytes, a type of white blood cell that normally produces
antibodies and serves important immune functions. Patients with CLL typically
develop symptoms that may progress over a period of years, ultimately
producing a generalized depression of immunity, marked increases in the size
of spleen, liver and lymph nodes, and impaired production of other normal
blood cells. Eventually, these problems may cause life-threatening
complications, such as overwhelming infections and fatal bleeding. More
information about CLL can be accessed at the website for the Lymphoma Research
Foundation at: http://www.lymphoma.org.
About Genasense
Genasense inhibits production of Bcl-2, a protein made by cancer cells
that is thought to block chemotherapy-induced apoptosis (programmed cell
death). By reducing the amount of Bcl-2 in cancer cells, Genasense may
enhance the effectiveness of current anticancer treatment. Genta is pursuing
a broad clinical development program with Genasense evaluating its potential
to treat various forms of cancer.
About Genta
Genta Incorporated is a biopharmaceutical company with a diversified
product portfolio that is focused on delivering innovative products for the
treatment of patients with cancer. Two major programs anchor the Company's
research platform: DNA/RNA-based Medicines and Small Molecules. Genasense(R)
(oblimersen sodium) Injection is the Company's lead compound from its DNA/RNA
Medicines program. Genta is currently recruiting patients to the AGENDA
Trial, a global Phase 3 trial of Genasense in patients with advanced melanoma.
The leading drug in Genta's Small Molecule program is Ganite(R) (gallium
nitrate injection), which the Company is exclusively marketing in the U.S. for
treatment of symptomatic patients with cancer-related hypercalcemia that is
resistant to hydration. The Company has developed G4544, an oral formulation
of the active ingredient in Ganite, that has recently entered clinical trials
as a potential treatment for diseases associated with accelerated bone loss.
The Company is also developing tesetaxel, a novel, orally absorbed, semi-
synthetic taxane that is in the same class of drug as paclitaxel and
docetaxel. Ganite and Genasense are available on a "named-patient" basis in
countries outside the United States. For more information about Genta, please
visit our website at: www.genta.com.
Safe Harbor
This press release may contain forward-looking statements with respect to
business conducted by Genta Incorporated. By their nature, forward-looking
statements and forecasts involve risks and uncertainties because they relate
to events and depend on circumstances that will occur in the future. Forward-
looking statements include, without limitation, statements about:
-- the Company's ability to obtain necessary regulatory approval for
Genasense(R) from the U.S. Food and Drug Administration ("FDA") or
European Medicines Agency ("EMEA");
-- the safety and efficacy of the Company's products or product
candidates;
-- the Company's assessment of its clinical trials;
-- the commencement and completion of clinical trials;
-- the Company's ability to develop, manufacture, license and sell its
products or product candidates;
-- the Company's ability to enter into and successfully execute license
and collaborative agreements, if any;
-- the adequacy of the Company's capital resources and cash flow
projections, the Company's ability to obtain sufficient financing to
maintain the Company's planned operations, or the Company's risk of
bankruptcy if it is unsuccessful in obtaining such financing or in
securing shareholder approval to increase the number of shares
authorized for issuance under the Company's certificate of
incorporation, as required by the transactional documents in our recent
financing;
-- the adequacy of the Company's patents and proprietary rights;
-- the impact of litigation that has been brought against the Company and
its officers and directors and any proposed settlement of such
litigation; and
-- the other risks described under Certain Risks and Uncertainties Related
to the Company's Business, as contained in the Company's Annual Report
on Form 10-K and Quarterly Report on Form 10-Q.

The Company does not undertake to update any forward-looking statements.
There are a number of factors that could cause actual results and developments
to differ materially. For a discussion of those risks and uncertainties,
please see the Company's Annual Report on Form 10-K for 2007 and its most
recent quarterly report on Form 10-Q.
CONTACT:
Genta Investor Relations
info@genta.com

SOURCE Genta Incorporated

Genta Investor Relations, +1-908-286-3980, info@genta.com