FDA Accepts Genta's NDA Amendment as Complete Response for Genasense(R) Treatment of Chronic Lymphocytic Leukemia
14 Julio 2008 - 7:05AM
PR Newswire (US)
Submission Based on Increased 5-Year Survival in Responding
Patients BERKELEY HEIGHTS, N.J., July 14 /PRNewswire-FirstCall/ --
Genta Incorporated (OTC:GNTA) (BULLETIN BOARD: GNTA) announced that
the Food and Drug Administration (FDA) has accepted the Company's
amendment to its New Drug Application (NDA) for Genasense(R)
(oblimersen sodium) Injection as a "complete response". The NDA
proposed the use of Genasense plus chemotherapy for patients with
relapsed or refractory chronic lymphocytic leukemia (CLL). The
recent submission was based on new information from the Company's
completed, randomized 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 amendment responds to a communication
received in March 2008 from FDA's Center for Drug Evaluation and
Research (CDER) that denied Genta's appeal of a prior
"non-approvable" decision of the Genasense NDA in December 2006.
That communication described a regulatory path forward that
included but was not limited to determination of long-term survival
in patients who entered the study. FDA has informed the Company
that it considers Genta's complete response as a Class 2
resubmission with a Prescription Drug User Fee Act (PDUFA) goal
date of December 3, 2008. "We are pleased that the FDA will
formally review this new information, and we look forward to
working with FDA's Division of Oncology Drug Products during their
consideration of this amendment," 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:
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(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.
DATASOURCE: Genta Incorporated CONTACT: Genta Investor Relations,
+1-908-286-3980, Web site: http://www.genta.com/
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