Incorporated (Nasdaq: GNTA) announced initiation of a Phase 1 clinical
trial using a new anticancer drug derived from the Company's DNA/RNA
Medicines program. The new compound, known as G4460, uses antisense
technology to target an oncogene known as c-myb that regulates key
functions in cancer cells. Using an accelerated dosing schedule, this study
will evaluate dosing regimens, safety, biologic activity, and
down-regulation of c-myb in patients with advanced hematologic cancers. The
clinical trial will be conducted using the General Clinical Research Center
at the University of Pennsylvania, Philadelphia, PA. G4460 has been granted
Orphan Drug Designation by the Food and Drug Administration for treatment
of patients with chronic myelocytic leukemia (CML).
"The c-myb proto-oncogene regulates a number of proteins that are
critical for growth of cancer cells," commented Dr. Alan Gewirtz, Professor
of Medicine and Pathology at the University of Pennsylvania School of
Medicine and Leader of the Hematologic Malignancies Program in the Cancer
Center. "Preclinical studies have shown that disruption of c-myb has
antitumor effects, and this new trial seeks to evaluate whether these
effects can be translated into an effective therapeutic strategy for
patients."
About G4460
G4460 is part of Genta's DNA/RNA Medicines program. This program uses
drugs that are based on chemical modifications of DNA or RNA to selectively
knock out the function of genes that may be involved in the cause or
progression of cancer. G4460 targets an oncogene product known as c-myb,
which is a protein that directly binds to cellular DNA. C-myb is believed
to regulate the expression of other genes that are involved in the growth
and differentiation of cancer cells. Over-expression of c-myb blocks
differentiation, promotes proliferation, and decreases apoptosis. Potential
clinical targets for G4460 include CML, melanoma, neuroblastoma, and
cancers of the breast, pancreas and colon. Genta has licensed key patents
and technology related to the composition and human use of G4460.
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 also completed a Marketing
Authorization Application to the European Medicines Agency (EMEA) for use
of Genasense plus dacarbazine for treatment of 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. 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
genta
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