Genta Initiates Clinical Trial of Genasense(TM) Plus Thalidomide In Patients ...
BERKELEY HEIGHTS, N.J., Sep 23, 2002 /PRNewswire-FirstCall via COMTEX/ -- Genta Incorporated (Nasdaq: GNTA) announced today the initiation of a new clinical trial with its lead anticancer drug, Genasense(TM), in patients with multiple myeloma. The study will assess the safety and efficacy of Genasense in combination with thalidomide (Thalomid(R); Celgene Inc.,) and dexamethasone in patients who have failed standard therapy. The trial will be conducted at the University of Maryland and is sponsored by U.S. National Cancer Institute, pursuant to Genta's Cooperative Research and Development Agreement (CRADA).
Genasense works by inhibiting the production of Bcl-2, a protein made by cancer cells that blocks chemotherapy-induced cell death. By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current anticancer treatments. Recent preclinical data have shown that Bcl-2 is a principal cause of chemotherapy resistance in myeloma cells, and that pre-treatment of myeloma cells with Genasense greatly increases the effectiveness of dexamethasone, the most commonly used drug for this disease.
"Although high-dose chemotherapy with stem-cell support has improved the outcome for patients with multiple myeloma, few, if any, patients are actually cured of the disease," commented Dr. Judith Karp, Associate Director for Clinical Research, and Head of the Hematologic Malignancy Program at the University of Maryland in Baltimore. "Patients who relapse from standard approaches have a very poor prognosis. The dexamethasone/thalidomide combination is widely employed in the medical community, and we believe the inclusion of Genasense may further optimize this regimen."
"Genta is committed to establishing a leadership role in the hematologic cancers. This study represents our second clinical trial in patients with plasma cell diseases, which includes the ongoing randomized trial in myeloma," noted Dr. Loretta M. Itri, Genta's Executive Vice-President and Chief Medical Officer. "This trial represents part of our comprehensive program to document synergy with a wide variety of anticancer agents."
About Multiple Myeloma
Multiple myeloma is a cancer of white blood cells that are called plasma cells. In myeloma, these cells, which normally produce infection-fighting antibodies, become mutated and then multiply uncontrollably. This proliferation crowds out normal red and white blood cells, leading to infections, bleeding and anemia. The illness also decreases production of normal antibodies and causes widespread destruction of bone that produces fractures, pain and progressive disability.
Myeloma is the second most common type of hematologic cancer, just behind chronic lymphocytic leukemia (CLL), which is also undergoing a randomized trial with Genasense plus chemotherapy. Recent statistics indicate that the incidence of myeloma is increasing, while the median age of disease onset is decreasing. About 11,200 people in the United States are expected to die of this disease this year. Among African Americans, multiple myeloma is one of the top 10 leading causes of cancer death. More information about the disease is available through the Multiple Myeloma Research Foundation: multiplemyeloma.org
Genta is currently conducting a randomized, multi-center trial evaluating high-dose dexamethasone with or without Genasense in patients whom have relapsed from front-line therapy. For patients with multiple myeloma and/or referring physicians whom would like to learn more about this trial, including eligibility and inclusion criteria, should call 1-888-TO-GENTA.
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. GenasenseTM, 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.
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SOURCE Genta Incorporated
CONTACT: Tara Spiess, Director, Corporate Communications of Genta Incorporated, +1-908-286-3980; or media, Hala Bashir of Noonan Russo Presence, +1-212-845-4277; or I.R., Brian Korb of Trout Group, +1-212-477-9007, both for Genta Incorporated
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