{"id":3091,"date":"2006-09-09T23:11:09","date_gmt":"2006-09-09T22:11:09","guid":{"rendered":"http:\/\/moomango.co.uk\/htb\/?p=3091"},"modified":"2013-12-06T16:40:21","modified_gmt":"2013-12-06T16:40:21","slug":"three-class-experienced-patients-experience-1-log-viral-load-reduction-using-monoclonal-antibody-tnx-355","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/3091","title":{"rendered":"Three-class experienced patients experience 1 log viral load reduction using monoclonal antibody TNX-355"},"content":{"rendered":"

Simon Collins, HIV i-Base<\/strong><\/p>\n

The late-breaker session also included a presentation of 48-week results from Tanox\u0092s monoclonal antibody, TNX-355, in 82 triple-class experienced patients (87% male, 46% Causacian, mean age 46.<\/strong> [1]<\/p>\n

TNX-355 is a humanised monoclonal antibody that binds to domain 2 of the CD4 receptor, blocking entry of HIV-1 into target cells. This randomised, double-blind, placebo-controlled study used two doses of TNX-355 plus optimised background regimen (OBR) compared to placebo plus OBR. The primary endpoint was mean change in viral load at week 24 (reported at ICAAC last year [2]), with additional safety and efficacy data presented in this analysis through to week 48.<\/p>\n

TNX-355 was given intravenously 10mg\/kg once-weekly for 9 weeks followed by either 10mg\/kg. 15mg\/kg or placebo every 2 weeks. All patients received OBR. After virologic failure (< 0.5 log10 drop from baseline after week 16), patients received 15 mg\/kg open-label TNX-355 every two weeks in combination with new OBR. This was a generally male, Caucasian study, with CD4 counts 200-300 cells\/mm3<\/sup> and viral load 4.8 logs. Further baseline characteristics are detailed in Table 1.<\/p>\n

Both TNX-355 arms showed sustained viral load reductions of \u00960.7 to \u00960.9 logs at week 48 compared to placebo, which was matched by mean CD4 increases of around +50 cells\/mm3<\/sup> (detailed in Table 1). Time to loss of virologic response (TLVR) was 230 and 253 days in the 10mg and 15mg arms respectively, compared to 0 days in the placebo group. Although all groups received OBR, T-20 was not allowed in the study, and details on the use of OBR drugs were not presented.<\/p>\n

Table 1: Baseline characteristics and ITT responses to TNX-355<\/strong><\/p>\n\n\n\n\n\n\n\n\n\n\n
<\/th>\n15mg\/kg + OBR<\/th>\n10mg\/kg + OBR<\/th>\nplacebo + OBR<\/th>\n<\/tr>\n
N<\/td>\n28<\/td>\n27<\/td>\n27<\/td>\n<\/tr>\n
Age<\/td>\n47<\/td>\n44<\/td>\n46<\/td>\n<\/tr>\n
% male\/female<\/td>\n78\/22<\/td>\n93\/7<\/td>\n89\/11<\/td>\n<\/tr>\n
Baseline CD4 (%<200)<\/td>\n229 (26%)<\/td>\n223 (51%)<\/td>\n245 (43%)<\/td>\n<\/tr>\n
Baseline VL (%>5log)<\/td>\n4.8 (26%)<\/td>\n5.0 (57%)<\/td>\n4.8 (33%)<\/td>\n<\/tr>\n
Mean change in CD+<\/td>\n+51 (p=0.016)<\/td>\n+48 (p=0.031)<\/td>\n+1<\/td>\n<\/tr>\n
Mean VL change wk 48<\/td>\n-0.71 (p<0.010)<\/td>\n-0.96 (p<0.001)<\/td>\n-0.14<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

References:<\/p>\n

    \n
  1. Norris D, Morales J, Godofsky E et al. 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. Late breaker abstract THLB0218.<\/li>\n
  2. Godofsky E, Zhang X, Sorenson M, et al. In vitro antiretroviral activity of the humanized anti-CD4 monoclonal antibody, TNX-355, against CCR5, CXCR4, and dual-tropic isolates and synergy with enfuvirtide. 45th Interscience Conference on Antimicrobial Agents and Chemotherapy. December 16-29, 2005. Washington, DC. Abstract LB-26. See report in HTB Jan\/Feb 2006.
    \nhttp:\/\/www.i-base.info\/htb\/3096<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base The late-breaker session also included a presentation of 48-week results from Tanox\u0092s monoclonal antibody, TNX-355, in 82 triple-class experienced patients (87% male, 46% Causacian, mean age 46. [1] TNX-355 is a humanised monoclonal antibody that binds …<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,3],"tags":[151],"class_list":["post-3091","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-antiretrovirals","tag-aids-16th-toronto-2006"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/3091","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=3091"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/3091\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=3091"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=3091"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=3091"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}