HOUSTON, Nov. 9 /PRNewswire-FirstCall/ -- Tanox, Inc. Medical Director Dr. Stanley Lewis recently presented findings from the Phase I clinical trial of TNX-355 for the treatment of human immunodeficiency virus (HIV) at the 2004 International Meeting of the Institute of Human Virology (IHV) in Baltimore, Md.
In a conference track titled "New Approaches to HIV Therapy," Lewis discussed the safety and anti-HIV activity of TNX-355 in testing conducted in HIV-infected patients during the trial.
TNX-355 is a humanized, non-immunosuppressive anti-CD4 monoclonal antibody that works by blocking the ability of HIV to enter CD4 cells. It is one of a new class of drugs called viral entry inhibitors. Entry inhibitors have the potential to offer significant advantages to treatment naive and treatment- experienced patients over some currently available therapies due to the low risk of cross-resistance.
"The annual IHV meeting is highly regarded in the scientific community as a central forum to discuss viral diseases," said Lewis. "There is significant interest among researchers and clinicians regarding the potential of antiviral entry inhibitors for HIV treatment, which are viewed by many experts as the next step in the evolution of anti-HIV therapy."
The Phase Ib clinical trial for TNX-355 was completed in 2003. Results from the trial indicated that TNX-355 appeared to be safe and well tolerated. The drug demonstrated a transient, but clinically significant, reduction in viral load, with no CD4 cell depletion. TNX-355 received Fast Track status from the U.S. Food and Drug Administration (FDA) in October 2003.
A Phase II clinical trial for the drug began in May 2004. The study is a three-arm, double-blind, placebo-controlled study, which will enroll approximately 80 patients. All patients will be anti-retroviral therapy- experienced, and will receive optimized background therapy during the study, in addition to one of two doses of TNX-355 or placebo. Data from the trial is expected in the second half of 2005.
The International Meeting of the Institute of Human Virology, held Oct. 31-Nov. 4, is one of the leading worldwide gatherings of HIV/AIDS researchers and physicians. The conference provides researchers the opportunity to present data, exchange ideas and information and explore opportunities for collaboration. Founded in 1996, the Institute of Human Virology works to discover new therapies for a variety of viral and immune disorders, especially HIV.
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 asthma, allergy, oncology, inflammation and infectious diseases. Tanox's first- approved drug, Xolair(R) (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 AG and was approved for marketing in the United States in 2003 for adult and adolescent patients with moderate-to-severe allergic asthma. Tanox is based in Houston, Texas. Additional corporate information is available at http://www.tanox.com/ .
This news release contains forward-looking statements based on current expectations that involve a number of risks and uncertainties. Prospective investors should carefully consider the information contained in the company's Form 10-K and other Securities and Exchange Commission (SEC) filings, including the sections titled Business: Forward-looking Statements and Business: Factors That May Affect Our Future Results; and Management's Discussion and Analysis of Financial Condition and Results of Operations, when evaluating an investment in the shares of Tanox Common Stock. The Tanox logo is a registered trademark with the U.S. Patent and Trademark Office.