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ibalizumab
Oct 29, 2012

dear nelson, i read that u experienced a clinical trial with ibalizumab and gained UD viral load status since then. when is it actually going to be in the pharmacy shelf? r u optimistic about the new monoclonal antibody ibalizumab for CD4? do we need to use it as a component of HAART or just monotherapy? if possible please post some more relevant information on this new molecule. Regards.

Response from Mr. Vergel

Ibalizumab is probably the HIV antiretroviral that has taken the longest time to get approved. The FDA has had the company redo a phase 2 study, which in my point of view was unfortunate since this small company enrolled deep salvage patients with no other options, which tends to obscure efficacy data.

Taimed is the company that owns the rights of this drug that is dosed every two weeks intravenously. They are also developing another formulation of the drug that can be dosed subcutaneously every two weeks. The main problem is that the company has no funds to do the large phase 3 studies required to get the drug approved, so they are looking for another company that could sponsor with them.

I am working with some doctors in a project to try to give access to this drug to patients who have no more options along with ViiV's new integrase inhibitor. However, the project is on hold until Taimed finds a company sponsor.

Ibalizumab will need to be used with current daily oral antiretrovirals.

Since we are talking about long acting HIV medications, ViiV (GSK) is working on long acting antiretrovirals that will be dosed every 2-4 weeks. Stay tuned!

GSK is Exploring a Once a Month Injectable HIV Treatment Regimen

Nelson



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