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Tanox completes enrollment of Phase 2 clinical trial of TNX-355 in HIV Treatment-Experienced Patients
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Press release from company
HOUSTON - Tanox, Inc. (NASDAQ: TNOX) has completed enrollment in its Phase 2 clinical trial of TNX-355 for the treatment of the human immunodeficiency virus (HIV). The study, which has enrolled the target of 80 patients, is being conducted at 30 sites in the United States, Canada and Puerto Rico.
The Phase 2 study is a three-arm, double-blind, placebo-controlled study evaluating the safety and efficacy of TNX-355, as assessed by viral load reduction. The study compares the effects of two different dosages administered by infusion of TNX-355 added to optimized background therapy (OBT) with the effect of OBT plus placebo in treatment-experienced, HIV-1 infected patients who have failed highly active antiretroviral therapy (HAART).
"Following encouraging proof-of-concept results in our Phase 1 trials, we were eager to pursue our studies of TNX-355 as an option for treatment-experienced, HIV-1 infected patients for whom currently available therapies are inadequate," said Nancy T. Chang, president and Chief Executive Officer of Tanox. "We plan to present interim, 24-week data from the Phase 2 trial in the fourth quarter of this year."
TNX-355 is a humanized, non-immunosuppressive anti-CD4 monoclonal antibody that works by blocking the ability of HIV to enter CD4-positive cells. The CD4 receptor on host cell surfaces is considered a gateway for HIV infection. This monoclonal antibody is a viral entry inhibitor and a first-in-class CD4 antagonist. Results from Phase 1 studies showed that TNX-355 was well tolerated and resulted in a clinically meaningful reduction of viral load in treatment-experienced patients infected with HIV. A Phase 1b trial showed a viral load reduction lasting five to seven weeks with multiple doses.
TNX-355 received Fast Track Status from the U.S. Food and Drug Administration in 2003.
"The feedback from physicians involved in the Phase 2 study has been encouraging," said Dr. Stanley Lewis, Tanox's medical director for TNX-355. "Investigators have reported that they are pleased with adherence and intravenous dosing of the drug has not been an obstacle."
The primary endpoint for the Phase 2 trial is a significant reduction in viral load levels between either of the active arms versus the control - OBT - arm at 24 weeks. A significant viral load reduction is defined as > 0.5 log10. Secondary objectives of the study will focus on change in percentage and number of CD4 cell count from baseline; the proportion of patients who achieve a reduction of > 1.0 log10 HIV-1 RNA; the proportion of patients who achieved an undetectable HIV-1 RNA; the extent of emergence of resistance; time to loss of virologic response (TLOVR); and Average Area Under the Curve Minus Baseline (AAUCMB).
About Tanox, Inc.
Tanox is a biotechnology company specializing in the discovery and development of biotherapeutics based on monoclonal antibody technology. The company develops innovative therapeutic agents for the treatment of immune-mediated diseases, inflammation, infectious disease and cancer. Its lead investigational therapy, TNX-355, is a humanized, anti-CD4 monoclonal antibody to treat HIV and AIDS. TNX-355 received Fast Track Status from the U.S. Food and Drug Administration in 2003 and is currently in Phase 2 clinical testing. Tanox's first-approved drug, Xolairš (omalizumab), is the first anti-immunoglobulin E (anti-IgE) antibody to be brought to market. Xolair was developed in collaboration with Genentech, Inc. and Novartis Pharma A.G. and was approved for marketing in the United States in 2003 for adult and adolescent patients with moderate-to-severe, confirmed allergic asthma. Tanox is based in Houston, Texas and maintains a manufacturing facility in San Diego, California.
This news release contains forward-looking statements regarding the potential for TNX-355 as a treatment for HIV-1-infected patients. These statements are based on Tanox's current beliefs and expectations, and are subject to risks and uncertainties that could cause actual results to differ materially. The timing of announcement of interim results from the Phase 2 study is subject to the ability of Tanox to manufacture drug supplies, maintain the defined level of patient participation and overcome other technical hurdles and issues. The therapeutic potential of TNX-355 as a treatment for HIV-1- infected patients is subject to the risks inherent in drug development. Drug development involves a high degree of risk. Drugs may not show therapeutic effect or an acceptable safety profile in early stage clinical trials. Success in early stage clinical trials does not ensure that later stage or larger scale clinical trials will be successful. The results achieved in later stage trials may not be sufficient to meet applicable regulatory standards. Problems or delays may arise during clinical trials or in the course of developing, testing or manufacturing drugs. For more detailed information on the risks and uncertainties associated with Tanox's drug development and other activities, see Tanox's periodic reports filed with the Securities and Exchange Commission.
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