BERKELEY HEIGHTS, NJ - December 2, 2008
- Genta Incorporated (OTCBB: GNTA.OB) today announced that the
Company has received a complete response letter from the Office of
Oncology Drug Products (OODP) at the Food and Drug Administration
(FDA) regarding the Company's amended New Drug Application (NDA)
for the use of Genasense® plus chemotherapy in patients with
chronic lymphocytic leukemia (CLL). In its letter, OODP
indicated that the Division cannot approve the NDA in its present
form and suggested the need for an additional clinical study.
"We are disappointed with the Office decision", said Dr. Raymond
P. Warrell, Jr., Genta's Chief Executive Officer. "We believe
that Genasense amply demonstrated its efficacy and safety in
patients with relapsed or refractory CLL in a carefully designed
and well-conducted randomized clinical trial. While our
principal focus for Genasense remains the timely completion of our
randomized trial in melanoma -- now more than two-thirds enrolled,
CLL remains an important indication. We plan to consult with
clinical and regulatory advisors in our evaluation of next
steps."
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 to evaluate 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, the Company's ability to obtain sufficient financing
to maintain the Company's planned operations, or the Company's
risk of bankruptcy;
- the adequacy of the Company's patents and proprietary
rights;
- the impact of litigation that has been brought against the
Company; 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
info@genta.com
908-286-3980
