FDA Appeal Decision Indicates that Genasense® Approval in Chronic Lymphocytic Leukemia Will Require Additional Confirmatory ...
06 Marzo 2009 - 5:34PM
Business Wire
Genta Incorporated (NASDAQ: GNTA) announced that the Food and
Drug Administration�s (FDA) Center for Drug Evaluation and Research
(CDER) has decided that available data are not adequate to support
approval of Genasense� (oblimersen sodium) Injection for treatment
of patients with relapsed or refractory chronic lymphocytic
leukemia (CLL). In a decision issued in response to an appeal filed
by Genta in December 2008, CDER concluded that new information
submitted by the Company in its amended New Drug Application (NDA)
was insufficient, and the Agency has recommended conducting a
confirmatory clinical trial.
�While disappointed with this decision, we appreciate FDA�s
clarification of the path to U.S. regulatory approval in this
important indication,� commented Dr. Loretta M. Itri, Genta�s
President, Pharmaceutical Development, and Chief Medical Officer.
�The Company will discuss this decision with clinical and
regulatory authorities before determining our next steps. Genta
greatly appreciates the professional and collaborative
communications with FDA during this process, and we look forward to
working with FDA in addressing their recommended options for
securing the confirmatory data.�
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: 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. Such forward-looking
statements include those that express plan, anticipation, intent,
contingency, goals, targets, or future developments and/or
otherwise are not statements of historical fact. The words
�potentially�, �anticipate�, �could�, �calls for�, and similar
expressions also identify forward-looking statements. The Company
does not undertake to update any forward-looking statements.
Factors that could affect actual results include, without
limitation, risks associated with:
- the Company�s ability to obtain
necessary regulatory approval for Genasense� from the U.S. Food and
Drug Administration (�FDA�);
- 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.
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 2008 and its most recent quarterly report on Form
10-Q.
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