Updated on 2 May 2012
On the current status of TMB-355, Dr James Chang says, "A 113-patient phase IIb clinical trial of patients with multiple drug resistant HIV-1 infections was completed in January 2011. The primary efficacy endpoint is the proportion of patients achieving undetectable viral loads at week 24. Secondary objectives include evaluation of changes in viral load, CD4+ cell counts, TOLVR, PK sensitivity, susceptibility and safety."
TaiMed Biologics intends to seek a partner for phase III development which is expected to begin by 2012 using multinational clinical sites including Taiwan. The company plans to file biologics license application for Ibalizumab to the US FDA and to launch the commercial product by the end of 2013. In addition to TMB-355, TaiMed has been working on TMB- 607/TMB -657 and TMB-571.
During the first half of 2011, TaiMed Biologics signed a definitive agreement with a Canadian publicly-held biotechnology company, Ambrilia Biopharma, under which TaiMed Biologics will acquire exclusive worldwide rights to manufacture, develop and commercialize both protease inhibitor (PI) and integrase inhibitor programs for HIV. The PI program includes PPL-100, which has been shown to possess advantageous properties, such as a high genetic barrier, low cross-resistance profile and no requirement for ritonavir, boosting phase I trials.
(inputs from Vipul Murarka)