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|  |  Tanox, Inc. (TNOX) Reports Positive Results From Phase 2 Clinical Trial Of TNX-355, An Entry Inhibitor To Treat HIVPress Release October 26, 2005 HOUSTON, Oct. 26 /PRNewswire-FirstCall/ -- Tanox, Inc. today reported positive Phase 2 clinical results of its novel HIV drug candidate, TNX-355. The 24-week results of the study show that TNX-355 at the 1 0 mg/kg dose, when given in combination with optimized background therapy (OBT), produced a considerably greater reduction in viral load in HIV-infected patients than did placebo in combination with OBT. TNX-355 was well tolerated, with no serious adverse events related to the drug. The study met its primary endpoint with TNX-355 plus OBT demonstrating a statistically significant reduction in viral load -- the level of HIV in the bloodstream -- compared to placebo plus OBT at Week 24. Treatment with the 10 mg/kg dose of TNX-355 resulted in a viral-load reduction of 1.16 log10, compared with a 0.20 log10 reduction in the placebo group, representing a 0.96 log10 greater reduction (p<0.001) in viral load in the last observation carried forward analysis. The reduction was maintained even with the more conservative method of analysis in which patients without a Week 24 value had their baseline value assigned instead of carrying the last observation forward. In this analysis, treatment with the 10 mg/kg dose of TNX-355 resulted in a viral-load reduction of 1.19 log10, compared with a 0.32 log10 reduction in the placebo group, representing a 0.87 log10 greater reduction (p=0.002) in viral load. The mean maximum viral-load reduction from baseline during the 24-week period in the 10 mg/kg dose arm was 1.97 log10 (p=0.002). "This trial demonstrates the antiviral activity of TNX-355 in highly treatment-experienced patients, who often have few therapeutic options," said Dr. Jeffrey Nadler, professor of Medicine and director of Clinical Research, Division of Infectious and Tropical Diseases at the University of South Florida in Tampa and an investigator in the Phase 2 clinical trial of TNX-355. "The study results support the strategy of blocking HIV entry. Perhaps most encouraging, because of TNX-355's novel mechanism of action, we may have a powerful new weapon against multi-drug resistant HIV." Treatment with the 15 mg/kg dose of TNX-355 resulted in a viral-load reduction of 0.95 log10, compared with a 0.20 log10 reduction in the placebo group (p=0.003), representing a 0.75 log10 greater reduction in viral load in the last observation carried forward analysis. The Phase 2 clinical trial was designed to compare the effects of two doses of TNX-355 -- 10 mg/kg and 15 mg/kg -- to that of a placebo. All study patients received OBT (a standard-of-care regimen). Patients were randomized 1:1:1 to receive 10 mg/kg, 15 mg/kg or placebo every two weeks. Patients in the 10 mg/kg dose received a loading dose of 10 mg/kg every week for eight weeks. The primary endpoint was the mean change from baseline in HIV RNA at Week 24. Secondary Endpoints Key secondary endpoints included: the proportion of subjects achieving a viral-load reduction of at least 0.5 log10; the proportion of subjects achieving a viral-load reduction of at least 1.0 log10; and the mean change in CD4+ cell count from baseline. In the 10 mg/kg dose arm, 56 percent of patients achieved a viral-load decrease of at least 0.5 log10 at Week 24, demonstrating the durability of the reduction. In addition, 44 percent of patients had a viral-load decrease of at least 1.0 log10 at Week 24. "These data reveal that TNX-355 provides significant virologic benefit," said Nancy Chang, Ph.D., president and CEO of Tanox. "TNX-355 has the potential to provide considerable advantages over the current standard-of-care for HIV patients, and we look forward to working with the FDA on next steps toward bringing this therapy to a growing number of patients who have limited treatment alternatives." …
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