Two Trials Focus on Genasense in Combination with
Platinum-Based Cancer Therapy
BERKELEY HEIGHTS, NJ November 6, 2002
- Genta Incorporated (Nasdaq: GNTA), in collaboration with Aventis
(NYSE:AVE), announced today the initiation of two new clinical
trials using its lead anticancer drug, GenasenseTM in combination
with platinum-based chemotherapy for treatment of patients with
colorectal cancer and solid tumors. These trials will be sponsored
by the U.S. National Cancer Institute (NCI), pursuant to Genta's
Cooperative Research and Development Agreement (CRADA) with the
NCI.
The colorectal cancer trial will evaluate the
safety and efficacy of escalating doses of Genasense
TM
in combination with Eloxatin® (oxaliplatin;
Sanofi-Synthelabo, Inc.), 5-florouracil and Leukovorin. Oxaliplatin
for this study is being provided by Sanofi-Synthelabo under the
NCI-Sanofi CRADA for this agent. The study will be led by Dr.
Anthony Tolcher, Associate Director of the Institute of Drug
Development at the Cancer Therapy Research Center, San Antonio,
Texas. The second study will evaluate the safety and efficacy of
escalating doses of Genasense in combination with Carboplatin®
(paraplatin; Bristol-Myers Squibb) and paclitaxel in patients with
advanced solid tumors. The study will be lead by Dr. George
Wilding, Acting Director of the University of Wisconsin Cancer
Center in Madison.
"The recent approval of Eloxatin® has provided an
exciting new option for the treatment of metastatic colon cancer,"
said Dr. Tolcher. "I have had a great deal of experience working
with Genasense and believe that this trial could have great
potential for colon cancer patients.
"The paclitaxel/carboplatin combination is widely
used as a first-line therapy in patients with solid tumors,"
commented Dr. Raymond P. Warrell, Chairman and CEO at Genta.
"Unfortunately, high doses of the combination can lead to severe
reactions that frequently require dose reduction or discontinuation
of therapy. The addition of Genasense to more moderate doses of
Carboplatin and paclitaxel may ameliorate the cumulative toxicity
observed with this combination while still maintaining
efficacy."
About Genasense
TM
Genasense
TM
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
TM
is currently in multiple, late-stage, randomized clinical
trials in patients with malignant melanoma, multiple myeloma,
chronic lymphocytic leukemia (CLL) and non-small cell lung
cancer.
About Eloxatin® (oxaliplatin)
In August of 2002, Eloxatin® was approved by the
U.S. Food and Drug Administration for use in combination with
5-Florouracil and leucovorin for the treatment of metastatic colon
cancer. Colorectal cancer is the second leading cause of
cancer-related death in the U.S., accounting for more than 56,000
deaths annually. Eloxatin® is marketed in the US and Europe by
Sanofi-Synthelabo.
About Aventis
Aventis (NYSE: AVE) has one of the pharmaceutical
industry"s leading oncology portfolios, highlighted by Taxotere®
(docetaxel), one of the most widely used chemotherapeutic agents
worldwide for the treatment of patients with breast cancer and
non-small cell lung cancer. Taxotere® is also being studied
extensively for use in treating patients with multiple other tumor
types. Aventis also markets Campto® (irinotecan), for advanced
colon cancer, in countries outside of the U.S., and Anzemet®
(dolasetron mesylate), a 5HT3 inhibitor for the treatment of
chemotherapy-induced nausea and vomiting in the U.S. The company
has a rich pipeline of investigational oncology compounds in
addition to Genasense
TM
, including AVE8062, a unique vascular targeting agent that differs
from angiogenesis inhibitors in that it targets both existing and
newly developing blood vessels within tumors; flavopiridol, a novel
cell cycle inhibitor; 109881, a third-generation taxoid drug that
may offer benefits over available taxoids; LIT976, a new
formulation of Taxotere® designed to have an improved safety
profile; and the ALVAC cancer vaccines being developed through
Aventis Pasteur. Aventis also has on-going partnerships with Aphton
Pharmaceuticals for G17DT, a novel immunotherapy initially targeted
for gastrointestinal cancers, and MediGene AG for a vaccine to
treat malignant melanoma.
