NCI Initiates Trials of Genasense(TM) in Patients with Colorectal Cancer And Other Solid Tumors Two Trials Focus on Genasense in Combination with Platinum-Based Cancer Therapy
BERKELEY HEIGHTS, N.J., Nov 6, 2002 /PRNewswire-FirstCall via COMTEX/ -- Genta
Incorporated (Nasdaq: GNTA), in collaboration with Aventis (NYSE: AVE),
announced today the initiation of two new clinical trials using its lead
anticancer drug, Genasense(TM) 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 in combination with Eloxatin(R)(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(R) (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(R) 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
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 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(R) (oxaliplatin)
In August of 2002, Eloxatin(R) 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(R) 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(R) (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(R) (irinotecan), for advanced colon cancer, in
countries outside of the U.S., and Anzemet(R) (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, 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. |
