Tanox says results from TNX-355 trial show sustained viral load reductions

By E. Janene Geiss

Philadelphia, May 2 - Tanox, Inc. said Tuesday that 48-week results of its phase 2 clinical trial show that HIV-infected patients who received drug candidate TNX-355 in combination with an optimized background regimen maintained a considerably greater reduction in viral load than did patients given a placebo.

The 48-week results also showed that patients who received TNX-355 with an optimized background treatment experienced a statistically significant increase in CD4+ cells compared to those who received a placebo, according to a company news release.

At 48 weeks, treatment with a 10 mg/kg dose of TNX-355 resulted in a mean viral-load reduction of 0.96 log10, compared with a 0.14 log10 reduction in the placebo group, representing a 0.82 log10 greater reduction in viral load, officials said.

Patients who received a 15 mg/kg dose of TNX-355 had a mean viral-load reduction of 0.71 log10, compared with a 0.14 log10 reduction in the placebo group, representing a 0.57 log10 greater reduction in viral load.

In addition to experiencing sustained viral-load suppression, patients receiving the 10 mg/kg dose had a greater increase in CD4+ cells than patients who received a placebo, with mean CD4+ cell increases of 48 cells/mm3 and 1 cell/ mm3, respectively, officials said.

Patients who received the 15 mg/kg dose also experienced a greater increase in CD4+ cells than patients in the placebo group, with mean CD4+ cell increases of 51 cells/mm3 and 1 cell/ mm3, respectively, officials said.

Both doses of TNX-355 were well-tolerated, with no severe adverse events related to the drug as assessed by investigators. No infusion-site reactions were reported.

Tanox said it intends to submit additional 48-week data for presentation at the upcoming XVI International AIDS Conference in Toronto.

TNX-355 is a humanized monoclonal antibody and part of an emerging class of HIV therapies known as viral-entry inhibitors.

Tanox is a Houston biotechnology company specializing in development of monoclonal antibodies.

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