Genta Incorporated (Nasdaq: GNTA) announced today that LR3001, an antisense compound
directed against a gene known as c-myb, has received Orphan Drug designation
from the U.S. Food and Drug Administration (FDA) for the treatment of chronic
myelocytic leukemia (CML). Designation as an Orphan Drug, which is intended
to facilitate product development, provides eligibility for a seven-year
period of market exclusivity after approval, grants and tax credits for
research and development, and reduced filing fees for marketing applications.
Genta obtained rights to LR3001 from Temple University in December 2004.
The drug has been tested in two Phase 1 clinical trials in patients with
myeloid leukemias. Genta plans to pursue further clinical development of
LR3001 in patients with both hematologic cancers and solid tumors.
About LR3001
LR3001 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 cancer cause or
progression. LR3001 targets an oncogene 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 primitive cells, including Bcl-2, Bcl-XL, c-myc, cyclin A1, cyclin D1,
cdc2, and Cox-2. Over-expression of c-myb blocks differentiation, promotes
proliferation, and decreases apoptosis. Potential clinical targets for LR3001
include CML, malignant melanoma, neuroblastoma, and cancers of the breast,
pancreas and colon.
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,
the Company's lead compound from its oligonucleotide program is currently
undergoing late-stage, Phase 3 clinical testing. 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: genta.
Genta Forward Looking Statement
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 2004.
Genta Incorporated
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