Designation Now Established for Each of the Genasense
Registration Trials
Berkeley Heights, NJ - June 30, 2003-
Genta Incorporated (Nasdaq: GNTA) today announced that the U.S.
Food and Drug Administration (FDA) has designated Genasense
TM
(oblimersen sodium) as a "Fast Track" product for the treatment of
patients with chronic lymphocytic leukemia (CLL). Genasense, the
Company's lead anticancer agent being developed in collaboration
with Aventis, is being broadly studied for its ability to enhance
the effectiveness of anticancer therapies across a range of both
hematologic cancers and solid tumors.
Fast Track designation is intended to expedite
the regulatory review of new drugs that are intended to treat
serious or life-threatening conditions and that demonstrate the
potential to address unmet medical needs. As a consequence, a New
Drug Application (NDA) with this designation may be submitted to
FDA in separate sections, a process that enables the agency to
review the application and provide feedback to the Sponsor as these
portions are completed. The FDA has described CLL as a serious,
life-threatening disease complicated by risk of infection, severe
anemia and thrombocytopenia, that is incurable for the majority of
patients.
Genta's development program, which employs
Genasense plus chemotherapy, has the potential to address such an
unmet medical need. The designation as a Fast Track product by FDA
is specific to the regimen used in the Phase 3 trial of Genasense
in combination with fludarabine and cyclophosphamide, two standard
chemotherapy drugs used in CLL. Genta had submitted its request for
Fast Track designation subsequent to completion of enrollment in
this Phase 3 trial.
"Receipt of this designation in CLL is another
important milestone in our Genasense development program, which
reflects our ongoing dialogue with FDA on this product," noted Dr.
Raymond P. Warrell, Jr., Genta's Chairman and Chief Executive
Officer. "Having concluded enrollment in the first group of
randomized trials, the Company has now secured both Fast Track and
Orphan Drug designations from the FDA for all three of our programs
in melanoma, multiple myeloma, and CLL."
About CLL
CLL is the most common form of leukemia in
adults and an estimated 7,000 patients are expected to be diagnosed
this year. The disease arises in lymphocytes - white blood cells
that produce antibodies and normally serve 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 other normal blood
cells. Eventually, these problems may cause lifethreatening
complications such as overwhelming infections and fatal
bleeding.
About Genasense
Genasense
TM
works by inhibiting the production of Bcl-2, a protein made by
cancer cells. The presence of Bcl-2 is thought to block
chemotherapy- induced cell death; thus, by reducing the amount of
Bcl-2 in cancer cells, Genasense may enhance the effectiveness of
current anticancer treatments. Bcl-2 has been shown to be elevated
in most patients with CLL. Genta is conducting a very broad program
that examines whether Genasense can amplify the effectiveness of
multiple types of chemotherapy. Having completed enrollment in a
series of randomized trials in melanoma, multiple myeloma, and CLL,
Genasense is currently being tested in multiple additional clinical
trials, including patients with cancers of the prostate, breast,
lung and colon, in patients with hematologic cancers such as
non-Hodgkin's lymphoma, acute and chronic leukemias and myeloma,
and in children with solid tumors.
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 RNA/DNAbased medicines and small molecules.
Genasense
TM
(oblimersen sodium), the Company"s lead compound from its
oligonucleotide program, is being developed in collaboration with
Aventis and is currently undergoing late-stage, Phase 3 clinical
testing. The leading drug in Genta's small molecule program is
Ganite
TM
(gallium nitrate injection), which the Company intends to launch
later this year for treatment of cancer-related hypercalcemia that
is resistant to hydration. For more information about Genta, please
visit our website at:
http://www.genta.com/
.
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 2002.
SOURCE: Genta Incorporated
