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Early Clinical Results Suggest Genasense(TM) May Be Useful for Patients With Highly Resistant MM
12.10.02
12/10/2002
PR Newswire
(Copyright (c) 2002, PR Newswire)

Two Presentations at ASH Meeting Support Activity of Genasense In Plasma Cell Cancers

PHILADELPHIA, Dec. 10 /PRNewswire-FirstCall/ -- Genta Incorporated (Nasdaq: GNTA) in collaboration with Aventis (NYSE: AVE), announced the presentation of two studies that support the activity of Genasense(TM) in two types of plasma cell cancers known as multiple myeloma and Waldenstrom's macroglobulinemia. These results were presented on Monday at the 44th annual meeting of the American Society of Hematology (ASH) in Philadelphia, PA.

The first study reported preliminary results using Genasense in combination with a standard chemotherapy regimen called "VAD" (which consists of vincristine, adriamycin and high-dose dexamethasone). A key component of this trial was that eligible patients had to have already received and progressed on VAD therapy. Therefore, this study represented a "resistance reversal" approach. To date, 5 patients are fully evaluable; all 5 had failed VAD, plus high-dose chemotherapy and a stem cell transplant, and 4 of the 5 had also progressed on thalidomide. Despite this extensive pre-treatment, 3 of the 5 patients achieved a partial response with Genasense/VAD. The median duration of response currently exceeds 6 months. One additional patient achieved stabilization of disease. Serial measurements showed that Bcl-2 protein (i.e., the target of Genasense therapy) was decreased in patients' blood cells. Other than fatigue, side effects did not appear different from those expected from VAD chemotherapy alone.

In a second preclinical study, Genasense was evaluated in experiments using human cells of Waldenstrom's macroglobulinemia (WM), a disease that is similar to myeloma. Genasense used alone decreased Bcl-2 protein within these cells, which was correlated with an increase in cell death (apoptosis). Moreover, Genasense also amplified the killing of WM cells when used in combination with rituximab (Rituxan(R); IDEC/Genentech), fludarabine, and dexamethasone. Maximal cell death with these combinations also correlated with the time that Bcl-2 was maximally decreased.

"Together, these studies provide several important insights," commented Dr. Raymond P. Warrell, Jr. MD, Genta's Chief Executive Officer, who noted: "First, the most active component of VAD is now felt to be high-dose dexamethasone. While we have not focused on "resistance reversal" strategies as a registration strategy, these early clinical data clearly suggest that dexamethasone resistance can be modified by Genasense. Thus, these results directly support our Phase 3 trial of Genasense with high-dose dexamethasone in myeloma that should complete its target enrollment this month. Second, earlier this year we initiated new clinical trials using Genasense plus Rituxan, and -- together with the National Cancer Institute -- we are planning to initiate a new clinical trial in patients with Waldenstrom's. Lastly, fludarabine is a key component of our ongoing Phase 3 trial in CLL. Thus, the further documentation of Bcl-2 down-regulation in lymphoid cells, which synergistically increases the cytotoxicity of fludarabine, is further evidence of the contribution that Genasense may make to enhancing the effectiveness of current anticancer therapy."

About Multiple Myeloma and Waldenstrom's Macroglobulinemia

Multiple myeloma and Waldenstrom's macroglobulinemia are cancers that arise in blood cells (called plasma cells) that normally reside in the bone marrow. Plasma cells are important because they normally produce antibodies that fight off infections. When cancer develops in plasma cells, these cells markedly increase in number, which can cause severe bone pain and fractures; however, their ability to produce antibodies is actually greatly reduced. Therefore, people with these conditions are highly susceptible to infections. Malignant plasma cells are known to contain a high amount of Bcl-2 protein, which is targeted by Genasense. Further information about these diseases can be found at the website of the Multiple Myeloma Research Foundation: http://206.204.218.38/default.asp.

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 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: http://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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