NCI Initiates Trial of Genasense(TM) Plus Rituxan In Patients With Non-Hodgkin's Lymphoma
BERKELEY HEIGHTS, N.J., Oct. 29 /PRNewswire-FirstCall/ -- Genta Incorporated (Nasdaq:GNTA), in collaboration with Aventis (NYSE:AVE), announced today the initiation of a new clinical trial that uses its lead anticancer drug, Genasense(TM), in combination with Rituxan(R) (rituximab; Genentech/IDEC), in patients with recurrent non-Hodgkin's lymphoma (NHL). This study, which is designed to evaluate safety and efficacy of the combination, will be led by the University of Texas M. D. Anderson Cancer Center in Houston with additional sites at Princess Margaret Hospital in Toronto and Fox Chase Cancer Center in Philadelphia. The trial will be sponsored by the U.S. National Cancer Institute, pursuant to Genta's Cooperative Research and Development Agreement (CRADA).
Clinical studies published in both The Lancet and the Journal of Clinical Oncology have reported preliminary safety and efficacy results of Genasense when used alone in patients with advanced NHL. At the most recent meetings of the American Association of Cancer Research (AACR) and American Society of Hematology (ASH) investigators presented a number of preclinical studies demonstrating that Genasense strongly amplifies the anti-cancer activity of Rituxan. In one such study, anticancer activity was seen when both Rituxan and Genasense were used alone however, when used in combination a clear survival benefit was produced.
"Rituxan is now widely considered a standard of care for the treatment of patients with NHL," commented Dr. Anas Younes, Associate Professor of Medicine, M. D. Anderson Cancer Center. "The strong preclinical data have supported the rapid translation of these findings into our clinical programs."
"The Rituxan market seems to be growing at quite a fast pace. It is being used not only in NHL but front-line CLL and other lymphoid diseases. With the breath of Rituxan's use, and the substantial preclinical support for the Genasense/Rituxan combination, we made this a priority trial," commented Dr. Raymond P. Warrell, Chairman and Chief Executive Officer at Genta.
Links to the referenced articles/abstracts:
"Phase I Clinical and Pharmacokinetic Study of Bcl-2 Antisense
Oligonucleotide Therapy in Patients With Non-Hodgkin's Lymphoma" JCO
Vol 18 Issue 9 (May), 2000: 1812-1823
"Bcl-2 Antisense Therapy in Patients with non-Hodgkin's Lymphoma" Lancet
Ap19; 349 (9059):1137-41
"Bcl-2 antisense (G3139, oblimerson) enhances the in vitro and in vivo
response of EBV-associated lymphoproliferative disease to Rituximab."
AACR 43; 2853, 2002.
"Bcl-2 Antisense (GenasenseTM) Induces Apoptosis and Potentiates Activity
of Both Cytotoxic Chemotherapy and Rituximab in Primary CLL Cells." ASH
3358, 2002
"Sequence Dependent Interaction of Bcl-2 Targeted Antisense
Oligonucleotides (As-ODN) with Chemotherapy in Human DoHH2 Non-Hodgkin's
Lymphoma (NHL) Cells."AACR 42; 3914, 2001
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 clinical trials including malignant melanoma, multiple myeloma, chronic lymphocytic leukemia (CLL) and non-small cell lung cancer.
About Rituxan
Rituxan(R) (Rituximab) is a monoclonal antibody that binds to CD20, a molecule on the surface of lymphocytes. More than 90 percent of patients with B-cell NHL express CD20. Rituxan is indicated for the treatment of patients with relapsed or refractory, low grade or follicular, CD20-positive, B-cell non-Hodgkin's lymphoma (NHL), which is cancer of the lymphatic system. It's a disease that's fatal in the large majority of patients. Approximately 55,000 patients are diagnosed annually with NHL in the United States.
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), a reference treatment for advanced colon cancer, in countries outside of the US, 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 tohave 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.
About Genta
Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on anticancer therapy. The Company's research platform is anchored by oligonucleotide chemistry, particularly applications of antisense and decoy aptamer technology. Genasense(TM), the Company's lead compound, is being developed in collaboration with Aventis and is currently undergoing late-stage, Phase 3 clinical testing in several clinical indications. Genta's pipeline also comprises a portfolio of small molecules, including gallium-containing compounds and Androgenics compounds for prostate cancer. For more information about Genta, please visit our website at: www.genta.com.
The statements contained in this press release that are not historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the expectations, beliefs, intentions or strategies regarding the future. Without limiting the foregoing, the words "anticipates," "believes," "expects," "intends," "may" and "plans" and similar expressions are intended to identify forward-looking statements. The Company intends that all forward-looking statements be subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect the Company's views as of the date they are made with respect to future events, but are subject to many risks and uncertainties, which could cause the actual results of the Company to differ materially from any future results expressed or implied by such forward- looking statements. For example, the results obtained in pre-clinical or clinical studies may not be indicative of results that will be obtained in future clinical trials, and delays in the initiation or completion of clinical trials may occur as a result of many factors. Further examples of such risks and uncertainties also include, but are not limited to: the obtaining of sufficient financing to maintain the Company's planned operations; timely development, receipt of necessary regulatory approvals, and acceptance of new products; the successful application of the Company's technology to produce new products; the obtaining of proprietary protection for any such technology and products; the impact of competitive products and pricing and reimbursement policies; and changing market conditions. The Company does not undertake to update forward-looking statements. Although the Company believes that the forward-looking statements contained herein are reasonable, it can give no assurances that the Company's expectations are correct. All forward looking statements are expressly qualified in their entirety by this cautionary statement and other factors detailed in the Company's reports filed with the Securities and Exchange Commission.
Make Your Opinion Count - Click Here
tbutton.prnewswire.com
SOURCE Genta Incorporated; Aventis
CO: Genta Incorporated; Aventis
ST: New Jersey
SU:
prnewswire.com
10/29/2002 08:15 EST |
