FDA Advisory Committee Reviews Genasense(TM) for Use in Advanced Melanoma
03 Mai 2004 - 9:52PM
PR Newswire (US)
FDA Advisory Committee Reviews Genasense(TM) for Use in Advanced
Melanoma BERKELEY HEIGHTS, N.J. and BRIDGEWATER, N.J., May 3
/PRNewswire-FirstCall/ -- Genta Incorporated and Aventis presented
results of their Phase 3 trial of Genasense(TM) (oblimersen sodium)
Injection in combination with dacarbazine (DTIC) versus dacarbazine
alone at the Oncologic Drugs Advisory Committee (ODAC) of the U.S.
Food and Drug Administration (FDA). In the absence of increased
survival, the committee voted that the evidence presented today did
not provide substantial evidence of effectiveness, as measured by
response rate and progression-free survival, to outweigh the
increased toxicity of administering Genasense for the treatment of
patients with metastatic melanoma who have not received prior
chemotherapy. While the advisory committee's recommendation is not
binding, the FDA will consider it as the agency completes its
Priority Review of the New Drug Application (NDA) for Genasense.
"We strongly believe in the potential of Genasense and what it
represents to patients with advanced melanoma," said Dr. Raymond P.
Warrell Jr., Genta's Chairman and Chief Executive Officer. "We are
committed to its ongoing development and we will work closely with
the FDA to determine the appropriate next steps." "Advanced
melanoma represents a significant unmet medical need. While
disappointing, the committee's vote underscores the complexities of
treating this devastating disease," said Frank Douglas, MD, PhD,
Executive Vice President of Drug Innovation and Approval and a
Member of the Board of Management at Aventis. "We will work with
our partners at Genta to address any outstanding questions from the
FDA." Genta filed its NDA for Genasense in December 2003 and was
granted Priority Review. An FDA response on the Genasense NDA is
expected by June 8, 2004. The NDA for Genasense is based on results
from a Phase 3 randomized trial of Genasense plus dacarbazine in
patients with advanced melanoma. The study -- the largest
randomized trial ever conducted for advanced melanoma -- enrolled
patients at 139 sites in nine countries. Investigators randomly
assigned 771 patients who had not previously received chemotherapy
to either Genasense plus dacarbazine or dacarbazine alone. Patients
who received Genasense in addition to dacarbazine showed
significant improvement across clinical measures; a 51 percent
improvement in median progression-free survival (74 days vs. 49
days); an improvement in durable response rate of greater than or
equal to 6 months, (13 patients vs. 5 patients); and a 72 percent
increase in overall anti-tumor response rate (11.7 percent vs. 6.8
percent). During the meeting, the company also presented additional
information on complete responders that were not part of the
original NDA submission, and that have not been confirmed by the
FDA. Six additional patients were identified who achieved complete
responses in the follow-up period in the Genasense plus dacarbazine
group, yielding a total of 11 complete responses. In this update,
no additional complete responders were identified in the
dacarbazine alone group. In a randomized clinical trial in which
patients received Genasense combined with dacarbazine (n=371)
compared to dacarbazine alone (n=360), the most frequent serious
adverse event occurring in greater than or equal to 5% of patients
was fever (5.9% vs. 3.1%, respectively); the most frequent Grade 3
or 4 adverse events occurring in greater than or equal to 5% of
patients were neutropenia (21.3% vs. 12.5% respectively),
thrombocytopenia (15.6% vs. 6.4%), leukopenia (7.5% vs. 3.9%),
anemia (7.0% vs. 4.7%), and nausea (7.0% vs. 2.5%). 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
treatments for advanced melanoma. Genta and Aventis are pursuing a
clinical development program with Genasense evaluating its
potential to treat various forms of cancer. About Advanced Melanoma
Advanced melanoma is the most deadly form of skin cancer because it
has spread throughout the body forming secondary tumors. The
incidence of melanoma has increased more rapidly than any other
cancer, and has more than doubled in the last 30 years. According
to the American Cancer Society, more than 55,000 cases of melanoma
will be diagnosed in the U.S. in 2004. Melanoma is the number one
cause of cancer death in the United States for women aged 25 to 29,
and it ranks second in incidence to breast cancer in women aged
30-34. Globally, 132,000 melanoma skin cancers will occur globally
every year, according to the World Health Organization. About Genta
Genta Incorporated is a pharmaceutical company 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 RNA and DNA-based Medicines and Small
Molecules. Genasense(TM) (oblimersen sodium) Injection, the
Company's lead drug from its RNA-DNA Medicines program, is being
developed with Aventis and is currently undergoing late-stage,
Phase 3 clinical testing for additional indications. 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 patients with cancer-related
hypercalcemia that is resistant to hydration. For more information
about Genta, please visit our website at: http://www.genta.com/.
About Aventis Aventis is dedicated to treating and preventing
disease by discovering and developing innovative prescription drugs
and human vaccines. In 2003, Aventis generated sales of 16.79
billion euro (US $18.99), invested 2.86 billion euro (US $3.24) in
research and development and employed approximately 69,000 people
in its core business. Aventis corporate headquarters are in
Strasbourg, France. The company's prescription drugs business is
conducted in the U.S. by Aventis Pharmaceuticals Inc., which is
headquartered in Bridgewater, New Jersey. For more information,
please visit: http://www.aventis-us.com/. For Genta: 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. 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/Form 10-K for 2003. For
Aventis: Statements in this news release containing projections or
estimates of revenues, income, earnings per share, capital
expenditures, capital structure, or other financial items; plans
and objectives relating to future operations, products, or
services; future economic performance; or assumptions underlying or
relating to any such statements, are forward-looking statements
subject to risks and uncertainties. Actual results could differ
materially depending on factors such as the timing and effects of
regulatory actions, the results of clinical trials, the company's
relative success developing and gaining market acceptance for new
products, the outcome of significant litigation, and the
effectiveness of patent protection. Additional information
regarding risks and uncertainties is set forth in the current
Annual Report on Form 20-F of Aventis on file with the Securities
and Exchange Commission and in the current Annual Report --
"Document de Reference" -- on file with the "Autorite des marches
financiers" in France. DATASOURCE: Genta Incorporated CONTACT: Joy
Schmitt, Media Relations, +1-908-286-6449, , or Tara Spiess,
Investor Relations, +1-908-286-3980, , both of Genta Incorporated;
or Lisa Kennedy, +1-908-243-6361, , or Marisol Peron,
+1-908-243-7592, , both of Aventis U.S. Product Communications Web
site: http://www.genta.com/ http://www.aventis-us.com/
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