Submission Based on Increased 5-Year Survival Data for
Responding Patients
BERKELEY HEIGHTS, NJ - June 6, 2008
- Genta Incorporated (OTCBB: GNTA) announced that the Company
has submitted an amendment to the Food and Drug Administration
(FDA) for its New Drug Application (NDA) for Genasense® (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® (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® (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 drugs 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:
http://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® 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, and the Company's ability to obtain sufficient
financing to maintain the Company's planned operations;
- 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;
- the Company's ability to retain compliance with the NASDAQ's
listing qualifications; 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.
SOURCE: Genta Incorporated
CONTACT:
Genta Investor Relations
908-286-3980
info@genta.com
