BERKELEY HEIGHTS, NJ - December 9, 2003
-Genta Incorporated (Nasdaq: GNTA) announced results from several
studies that suggest Genasense
TM
(oblimersen sodium), the Company's lead anticancer compound,
enhances the activity of many types of chemotherapy in patients
with multiple myeloma. The results were presented by three
investigative groups at the annual meeting of the American Society
of Hematology (ASH) in San Diego, CA. Bcl-2, the protein target of
Genasense therapy, is expressed at high levels in patients with
myeloma. The protein has been shown to block the onset of myeloma
cell death that would otherwise be triggered by chemotherapy. By
blocking production of Bcl-2, Genasense may overcome the inherent
resistance of myeloma to anticancer treatment. Genta is broadly
exploring the use of Genasense as a means of enhancing the activity
of chemotherapy for myeloma in Phase 2 and Phase 3 trials.
In a Phase 1-2 clinical study from the University of Maryland,
25 patients with advanced myeloma were treated with escalating
doses of Genasense and thalidomide (Thalomid®; Celgene Corp.), plus
high-dose dexamethasone. All patients had received extensive prior
therapy. Twenty-three of 25 (92%) had previously progressed despite
having undergone stem cell or allogeneic transplantation. All had
previously received dexamethasone, and 11 had previously received
thalidomide. To date, 20 patients have completed induction therapy
and are evaluable for response. Twelve of the 20 patients (60%)
have achieved a major clinical response, including 2 complete
responses, 4 near-complete responses, and 6 partial responses. Four
other patients had a minor response. With a median of 7.5 months,
only 1 patient has relapsed, and 16 patients remain on study.
Updated results from a second clinical study were published in
the November 16, 2003 issue of Blood by a group from Utrecht, The
Netherlands. Ten patients with refractory myeloma participated in
this trial, 8 of whom were refractory to a standard drug
combination known as "VAD" (vincristine, doxorubicin, and
dexamethasone). Patients were treated with Genasense plus VAD. Of
the 9 patients who are currently evaluable, 4 have achieved a
partial response, and 3 have achieved a minor response. Median
progression-free survival was 6 months, and median overall survival
has not yet been reached.
Finally, in a preclinical study conducted by investigators at
Memorial Sloan-Kettering Cancer Center and Roswell Park Cancer
Institute, Genasense was combined with bortezomib (Velcade®
Millennium Pharmaceuticals, Inc.) in models of myeloma and
non-Hodgkin's lymphoma. Using 6 different cell lines, Genasense was
shown to amplify the apoptotic activity of Velcade. A separate
experiment using NHL xenografts showed that the chemosensitizing
enhancing activity of Genasense was schedule-dependent, and that
maximal activity was observed when Genasense was given before
dosing with Velcade rather than after.
"The development of new drugs capable of targeting unique
pathways in lymphoma has created new opportunities to sensitize
these cancers to traditional chemotherapy drugs," stated Dr. Owen
O'Connor, Head of Laboratory of Experimental Therapeutics for
Lymphoma, Memorial Sloan- Kettering Cancer Center. "Our data
suggest that these two drugs, when administered in a particular
order, can exquisitively sensitize lymphoma cells to
cyclophosphamide, producing cures in animals receiving the triple
combination. These approaches will no doubt pave the way for new
trials that will explore the merits of using these drugs in a
complimentary way with traditional chemotherapy programs."
"Multiple myeloma is the focus of considerable attention at
Genta. Enrollment into our Phase 3 multiple myeloma trial has
completed and will provide further clinical evaluation of the
Genasense/dexamethasone regimen that was presented today," observed
Dr. Loretta M. Itri, Genta's President, Pharmaceutical Development.
"The combination data with Thalomid and Velcade are logical and
promising extensions of our Genasense development program."
About Multiple Myeloma
Multiple myeloma is a cancer that arises in blood cells (called
plasma cells) that normally reside in the bone marrow. Plasma cells
normally produce antibodies that fight off infections. When cancer
develops in plasma cells, these cells markedly increase in number,
which can cause severe bone pain and fractures; however, their
ability to produce antibodies is actually greatly reduced.
Therefore, people with these conditions are highly susceptible to
infections. Malignant plasma cells are known to contain a high
amount of Bcl-2 protein, which is targeted by Genasense. Further
information about these diseases can be found at the website of the
Multiple Myeloma Research Foundation:
http://206.204.218.38/default.asp
.
About Genasense
Genasense works by inhibiting the production of Bcl-2, a protein
made by cancer cells that is thought to block chemotherapy-induced
cell death. By reducing the amount of Bcl-2 in cancer cells,
Genasense may enhance the effectiveness of current anticancer
treatments. Genasense is currently in multiple, late-stage
randomized and non-randomized clinical trials, including malignant
melanoma, multiple myeloma, chronic lymphocytic leukemia (CLL), and
non-small cell lung cancer. The Company has initiated the filing of
a New Drug Application to the Food and Drug Administration for
treatment of patients with advanced malignant melanoma using
Genasense plus dacarbazine.
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
TM
(oblimersen sodium), the Company's lead compound from its
oligonucleotide program, is being developed 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 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/
.
This press release and the conference call to follow 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. 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
