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Phase I Clinical Trial Of Monoclonal Antibody Initiated.(Brief Article)
2001 SEP 5 - (NewsRx.com & NewsRx.net) --
Tanox, Inc. (TNOX) announced that enrollment is now open in a Phase I clinical trial of a monoclonal antibody being developed for a new approach to the treatment of HIV.
After review of the Investigational New Drug Application submitted by Tanox, the U.S. Food and Drug Administration indicated that the study may proceed, and the first patient will be treated within weeks. The Phase I dose-escalation study will evaluate the safety and tolerability of single intravenous infusions of the monoclonal antibody, TNX-355 (formerly known as Hu5A8), in patients infected with HIV who have failed two courses of highly active antiretroviral therapy (HAART).
HAART typically involves a combination of three to four drugs - chosen from the available pool of 15 drugs approved for HIV infection - that may reduce viral load to undetectable levels in patients. The study's secondary objectives include measurements of pharmacokinetic parameters of TNX-355 after single-dose administration and its effects on viral load and CD4(+) cells.
TNX-355 is designed to bind to the CD4 receptor on host cell surfaces. CD4 is generally believed to be the gateway to HIV infection of cells and by binding ...
- Tanox Completes Enrollment of TNX-355 Phase 2 Clinical Trial for the Treatment...
- Press release article from: PR Newswire March 9, 2005 700+ words
...quarter of this year." TNX-355 is a humanized...immunosuppressive anti-CD4 monoclonal antibody that works by blocking...investigational therapy, TNX-355, is a humanized, anti-CD4 monoclonal antibody to treat HIV and AIDS. TNX-355 received Fast...
- New Research Reaffirms Tropism Independence of TNX-355; Data for Tanox's Novel...
- Press release article from: PR Newswire February 9, 2006 700+ words
...Lewis, Tanox medical director. TNX-355 is a humanized viral-entry inhibitor monoclonal antibody that coats CD4-positive cells...development later this year. About TNX-355 TNX-355 is a monoclonal antibody that binds to CD4 receptors on...
- Tanox Reports 48-Week Results From TNX-355 Phase 2 Clinical Trial.
- Press release article from: PR Newswire May 2, 2006 700+ words
...guided OBR (standard-of- care regimen). TNX-355 TNX-355 is a humanized monoclonal antibody and part of an emerging class of HIV therapies known as viral-entry inhibitors. TNX-355, which is administered intravenously...
- New Data Confirm Durable Response of TNX-355 Regimens Through 48 Weeks in...
- Press release article from: PR Newswire August 17, 2006 700+ words
...received a loading dose of 10 mg/kg every week for eight weeks. About TNX-355 TNX-355 is the most-advanced humanized monoclonal antibody in development to treat HIV/AIDS. TNX-355 is distinct from other entry inhibitors in that it binds to...
- Tanox to Initiate Phase I Clinical Trial of TNX-355 for HIV Infection.
- Press release article from: PR Newswire August 1, 2001 700+ words
...intravenous infusions of the monoclonal antibody, TNX-355 (formerly known...excited to expand our monoclonal antibody drug development programs...and CEO of Tanox. "TNX-355 represents the first monoclonal antibody in a new generation...
- Tanox Reports Positive Results From Phase 2 Clinical Trial of TNX-355, an Entry...
- Press release article from: PR Newswire October 26, 2005 700+ words
...groups and placebo. Both doses of TNX-355 were safe and well tolerated...site reactions were reported. TNX-355, Viral Entry Inhibitors, and Trial Overview TNX-355 is a humanized monoclonal antibody and part of an emerging class of...
- Tanox Initiates Phase 2 Clinical Trial of TNX-355 for HIV Infection.
- Press release article from: PR Newswire May 5, 2004 700+ words
...viral load reduction. TNX-355 will be administered...are expected in 2005. TNX-355 is a humanized...immunosuppressive anti-CD4 monoclonal antibody that works by blocking...HIV infection. This monoclonal antibody is one of a new class...studies showed that TNX-355 was well ...
- TNX-355 phase II clinical trial initiated for treatment of HIV.
- Newspaper article from: Biotech Week June 2, 2004 700+ words
...viral load reduction. TNX-355 will be administered...are expected in 2005. TNX-355 is a humanized...immunosuppressive anti-CD4 monoclonal antibody that works by blocking...HIV infection. This monoclonal antibody is one of a new class...studies showed that TNX-355 was well ...
Source: HighBeam Research, Phase I Clinical Trial Of Monoclonal Antibody Initiated.(Brief...