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Ibalizumab (TNX-355)
Sep 14, 2010

Hello Nelson!

Do you have a current update on Ibalizumab (TNX-355 -- now known as TMB-355)? Today, is 9-14-2010. Many Thanks.

East Texas

Response from Mr. Vergel

Sure! I am following that drug closely. I have been on this research drug for two years and have remained undetectable for the first time in a long long time. I am taking it with Selzentry and Intelence as active agents.

This new drug is very unique since it is a CD4 receptor blocker (one of the receptors on the CD4 cell that HIV uses to attach itself to the cell) and it is manufactured by a fancy monoclonal process. Read more here:

Ibalizumab info

The company is proceeding soon with applying for a new drug application with the FDA for HIV+ patients who have resistance to most classes of meds. It will be provided as an IV possibly every two weeks along wth oral meds. People need to have at least one and preferable two active agents in their genotype test to make sure this drug works to bring HIV viral load down to undetectable levels. Hopefully, GSK's new integrase GSK572 will be one of the additional active agents patients will be able to start with ibalizumab in an expanded access program to be started around summer-fall 2011.

You will have to go see your doctor every two weeks for the rest of your life unless the company approves other types of formulations, so it is a commitment.

I love the drug for obvious reasons. And so far, no side effects at all. The IV takes 30 minutes and I can say my health care has improved even more since I now see my doctor every two weeks and have got very close to his staff. It is difficult for me, however, to schedule my travel for conferences and lectures since I have to be in Houston every two weeks to get the IV. But that is a small price to pay for great health and hope for the future.

I certainly hope this drug gets approved. Some of us with multidrug resistance need it and there are now almost no drugs in the pipeline to help us. We need to stay awake since some companies are dropping out of HIV due to lack of funding or a saturated market. I will make sure that our voices are heard in meetings! Specially when I hear many researchers say that people with resistance to all meds do not exist in the United States anymore, or that we are in that situation for our own lack of adherence!

Keep tuned..I will have more updates as they come.

Nelson



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