Genta
Incorporated (Nasdaq: GNTA) announced that the U.S. Food and Drug
Administration (FDA) has notified the Company that it has extended the
review period for the currently pending New Drug Application (NDA) for
Genasense(R) (oblimersen sodium) Injection plus chemotherapy for patients
with relapsed or refractory chronic lymphocytic leukemia (CLL). Genta has
requested a meeting with FDA, and the Company has submitted additional data
analyses in support of the application. The FDA has indicated that
submission of the new information comprises a major amendment to the NDA
and has elected to extend the review period for 90 days to January 29,
2007.
"We are pleased that the FDA has agreed to consider this new
information during their review of the Genasense NDA," commented Dr.
Loretta M. Itri, Genta's President, Pharmaceutical Development, and Chief
Medical Officer. "Our pivotal trial met its primary endpoint in the only
controlled clinical trial ever conducted in this patient population.
Genasense significantly increased the number and length of durable complete
remissions, an endpoint that has consistently defined clinical benefit in
leukemia. Our new analyses reinforce that conclusion, and we look forward
to continued dialog with FDA regarding this application. While the NDA
remains under active review, we will continue to provide Genasense at no
cost to CLL patients in response to single-patient, 'compassionate use'
requests."
The Genasense NDA was reviewed at a meeting of the FDA's Oncologic Drug
Advisory Committee meeting on September 6, 2006 where it failed to receive
a majority vote to recommend approval. Information about the application
can be accessed at:
fda/ohrms/dockets/ac/06/briefing/2006-4235B1-01- .
Genasense in CLL
The NDA for Genasense was based on two separate clinical trials. The
first was a Phase 1-2 trial that demonstrated the safety and activity of
the drug used as a single-agent in 40 patients who had received extensive
anti- leukemic therapy. The second trial was a randomized, multicenter,
multinational trial in which 241 patients with relapsed or refractory CLL
received standard chemotherapy (fludarabine plus cyclophosphamide) with or
without Genasense. The trial met its primary endpoint, which was the
demonstration of a statistically significant increase in the proportion of
patients who achieved complete or nodular partial remission. Patients with
this level of remission have no overt evidence of leukemia. Moreover, these
remissions were durable (greater than 6 months in duration), they were
associated with significant improvement in signs and symptoms of leukemia,
and they lasted significantly longer when induced with Genasense compared
with chemotherapy alone.
Adverse events that were significantly higher in the Genasense group
included (but were not limited to) thrombocytopenia, nausea, fever,
fatigue, back pain, weight loss, dehydration, and intravenous catheter
complications. However, serious adverse events that resulted in
discontinuation of therapy were equal between the treatment arms.
Additional aspects of the safety and efficacy of Genasense can be viewed
at: fda/ohrms/dockets/ac/06/briefing/2006-4235B1-01-01Genta- .
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, and more than 60,000 people are living with CLL in the United
States. 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. For more information about CLL, visit
leukemia-lymphoma.
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. The Company's research platform is
anchored by two major programs that center on oligonucleotides (RNA- and
DNA- based medicines) and small molecules. Genasense(R) (oblimersen sodium)
Injection is the Company's lead compound from its oligonucleotide program.
The Company has submitted a New Drug Application (NDA) to the Food and Drug
Administration for the use of Genasense plus fludarabine and
cyclophosphamide for treatment of patients with relapsed or refractory
chronic lymphocytic leukemia (CLL). Genta has completed a Marketing
Authorization Application to the European Medicines Agency (EMEA) for use
of Genasense plus dacarbazine for treatment of patients with advanced
melanoma. Genta has additional randomized clinical trials ongoing in
patients with acute myeloid leukemia, hormone- refractory prostate cancer,
and lung cancer. 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. For more information
about Genta, please visit our website at: genta.
Safe Harbor
This press release contains 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, 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
-- 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 2005
and its most recent quarterly report on Form 10-Q.
Genta Incorporated
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