FDA gives fast-track status to HIV fusion inhibitor
BY Advocate.com Editors
October 11 2003 12:00 AM ET
The Food and Drug Administration on Thursday granted fast-track review status to an experimental HIV fusion inhibitor still in human tests by Houston-based pharmaceutical company Tanox, the Houston Chronicle reports. The quickened review process will allow the company to submit preliminary clinical trial data as soon as it becomes available. Typically, the FDA does not review the data until all human trials have been completed. The drug, called TNX-355, is designed to prevent HIV from being able to attach to and infect immune system cells. Laboratory and early human trials have shown the medication is effective when used with other antiretrovirals in lowering blood-based viral loads and that the medication may be highly effective for patients who've developed resistance to other anti-HIV medications. Tanox plans to begin a Phase II clinical trial in the first half of 2004. The only fusion inhibitor on the market, Fuzeon, was approved by the FDA earlier this year.