|
|
 |
Abstract
TNX-355, in Combination with Optimized Background Regimen (OBR), Achieves Statistically Significant Viral Load Reduction and CD4 Cell Count Increase When Compared with OBR alone in Phase 2 study at 48 Weeks
D. Norris1, J. Morales2, E. Godofsky3, F. Garcia4, R. Hardwicke5, S. Lewis6
1Comprehensive Research Center, Tampa, United States, 2Clinical Research Puerto Rico Inc., San Juan, Puerto Rico, 3Bach & Godofsky, Bradenton, United States, 4Valley AIDS Council, Harlingen, United States, 5University of Texas Health Science Center, Houston, United States, 6Tanox, Inc., Clinical Development, Houston, United States
Background: TNX-355 is a novel humanized monoclonal antibody that binds to domain 2 of the CD4 receptor, blocking entry of HIV-1 into target cells. A 48-week randomized, double-blind, placebo-controlled study assessed the safety and efficacy of two dosage regimens of TNX-355 plus OBR versus (vs.) placebo plus OBR. The primary endpoint was mean change in HIV-1 RNA (VL) from baseline (BL) at Week 24; additional assessments of safety and efficacy were conducted through Week 48.
Methods: Triple-class experienced HIV-infected patients were randomized to receive TNX-355 intravenously: 10mg/kg Q wk for 9 doses followed by 10mg/kg Q 2 wks; 15 mg/kg Q 2 wks, or placebo. All patients received OBR. After virologic failure (< 0.5 log10 drop from BL after week 16), patients received 15 mg/kg open-label TNX-355 Q 2 wks in combination with new OBR. An analysis of the intent-to-treat population was performed, along with statistical tests for immunologic and virologic measurements at 24 and 48-weeks, corrected for multiple comparisons of each TNX-355 arm vs. the placebo arm.
Results: 82 patients (87% male, 46% white) enrolled: mean age 46 years.
Summary of Week 48 Data:
*Non-completer=mean of last two values
Conclusions: TNX-355 in combination with OBR resulted in a statistically significant difference in viral load reduction compared to placebo plus OBR at Week 48. Treatment with TNX-355 is associated with durable viral load reductions and clinically meaningful increases in CD4 counts in treatment-experienced patients.
Back
|