HOUSTON, Aug. 3 /PRNewswire-FirstCall/ -- Tanox, Inc. has conducted a meeting with the Food and Drug Administration (FDA) to discuss clinical-trial results and continued development of TNX-355, the company's antibody being investigated for the treatment of HIV/AIDS.
While the FDA indicated that TNX-355 has demonstrated therapeutic potential in clinical testing, an additional dose-finding study will be needed. The FDA also indicated that a dose-finding trial, if appropriately designed and successful, could serve as one of the pivotal studies for a Biologics License Application (BLA) submission.
The company expects to continue its discussions with the Agency regarding clinical-trial design options over the next several weeks. The outcome of these discussions may delay the company's anticipated submission of a BLA.
"Despite the potential delay in our development program, we are encouraged that the FDA has recognized the therapeutic potential of TNX-355 in HIV treatment-experienced patients," said Danong Chen, president and chief executive officer. "This patient population has a limited number of treatment alternatives, and we continue to believe that TNX-355 could be a valuable option for patients. We plan to work closely with the Agency on a clinical- trial design to identify the appropriate dose and dosing regimen, and a clear path forward to a BLA."
The company intends to provide additional information about its development plan and timing of future clinical trials for TNX-355 later this quarter.
About TNX-355
TNX-355 is a humanized monoclonal antibody and part of the viral-entry inhibitor class of HIV therapies. TNX-355, which is administered intravenously, is distinct from other entry inhibitors in that it binds to CD4 receptors -- the primary target of HIV infection. Since TNX-355 blocks HIV entry at a step prior to the co-receptor interaction, it is "co-receptor tropism independent," with the ability to block both CCR5- and CXCR4-tropic viruses. The blockade presented by TNX-355 also does not depend on targeting a mutation-prone viral protein. TNX-355 has a Fast Track designation from the FDA.
About Tanox, Inc.
Tanox is a biotechnology company specializing in the discovery and development of monoclonal antibodies. The company develops innovative biotherapeutics for the treatment of immune-mediated diseases, inflammation, infectious disease and cancer. Tanox's first-approved drug, Xolair(R) (omalizumab), is the first antibody approved to treat moderate-to-severe confirmed allergic asthma. Xolair was developed in collaboration with Genentech, Inc. and Novartis Pharma AG and is approved for marketing in the United States, Canada and major European countries. Tanox is based in Houston and has a manufacturing facility in San Diego. Additional corporate information is available at http://www.tanox.com/ .
This news release contains forward-looking statements regarding the potential for TNX-355 as a treatment for HIV-1-infected patients and the anticipated timing and design of further clinical studies of TNX-355. 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 therapeutic potential of TNX-355 as a treatment for HIV-1- infected patients is subject to the risks inherent in drug development. The conduct or timing of any future trials can depend on many factors, including our discussions with the FDA, whether we choose to partner the program, and availability of sufficient quantities of clinical-trial material. Success in early stage clinical trials does not ensure that later-stage or larger-scale clinical trials will be successful, and 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. The Tanox logo is a registered trademark with the U.S. Patent and Trademark Office.
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