BERKELEY HEIGHTS, N.J., June 13 /PRNewswire-FirstCall/ -- Genta
Incorporated (Nasdaq: GNTA) today announced the presentation of clinical data
reporting the safety and activity of Genasense(R) (oblimersen sodium)
Injection, the Company's lead anticancer drug, in combination with rituximab
(Rituxan(R); Genentech IDEC). The trial was conducted in patients with
relapsed and refractory non-Hodgkin's lymphoma (NHL) by investigators from the
M.D. Anderson Cancer Center, Houston, TX, McMaster University, Hamilton,
Ontario, and the Fox Chase Cancer Center, Philadelphia, PA. The data were
presented by the trial's principal investigator, Dr. Barbara Pro, on Saturday
at the International Conference on Malignant Lymphoma in Lugano, Switzerland.
In this study, Genasense was administered daily for 7 days on weeks 1, 3
and 5, and rituximab was administered weekly for 6 weeks. Thirty-five
patients who had failed a median of 2 prior chemotherapy regimens with or
without rituximab were entered into this ongoing trial. To date, 6 patients
have achieved a complete response, one of whom was refractory to prior
rituximab therapy. Nine other patients have achieved a partial response for
an overall response rate of 42%. Patients with the specific subset of
follicular lymphoma showed a response rate of 56%. Twelve other patients have
had stable disease. Side effects of the combination appeared qualitatively
similar to that for rituximab alone, including but not limited to neutropenia,
fever, infection, anemia and fatigue.
Prior studies have shown preclinical synergy of Genasense with rituximab
in NHL (1,2). The concurrent treatment schedule employed in this clinical
study closely follows the optimized dosing regimen that was recently described
for the use of this combination (3). This study - the first to report
clinical activity of Genasense plus rituximab without the use of cytotoxic
chemotherapy - was supported in part by the National Cancer Institute. Recent
clinical studies have also demonstrated safety and activity when using
Genasense and rituximab in combination with chemotherapy, such as CHOP-R in
patients with mantle cell lymphoma (4). Ongoing work is also assessing the
use of Genasense in combination with rituximab plus fludarabine in patients
with chronic lymphocytic leukemia (CLL).
"The Genasense-rituximab combination trials are high priorities for the
Company in both NHL and CLL", commented Dr. Loretta M. Itri, President,
Pharmaceutical Development and Chief Medical Officer. "We anticipate that
future registration trials in both of these indications will incorporate the
use of rituximab. These early demonstrations of safety and activity are key
to the translation of promising preclinical work into patients, as well as for
building the combination regimens for new trials in these diseases."
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 in multiple
indications including malignant melanoma, chronic lymphocytic leukemia (CLL),
acute myeloid leukemia and non-small cell lung 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. 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: 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 2004.
SOURCE Genta IncorporatedWeb Site: http://www.genta.com/
