Moving Ahead: Prostratin Experiments Requested by the FDA

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January 27 2014

Stefanie Homann in the lab

By Stefanie Homann, PhD

I am happy to report that we have already completed initial experiments requested by the FDA in order to advance prostratin to human trials. We are assessing prostratin’s effects on two different reservoir cell types: T cells and monocytes. Our first experiments gauged which concentrations of prostratin reactivate model system reservoir cells and whether, once prostratin is removed, the reactivated cells stop producing virus. Our results so far have been affirmative. (See below graph.)

Further experiments required by the FDA include determining whether prostratin influences cell activity. Does prostratin affect cell proliferation rates? That is, do cells proliferate faster or slower than they would in controlled environments? Additionally, we are testing prostratin in conjunction with the antiretroviral drugs now in use in order to determine if there are any unexpected combination effects.

Next, we will conduct experiments to determine what concentration of prostratin is appropriate for optimal viral induction, as well as what the associated toxicity levels are. We will conduct these experiments ex-vivo, which means in cells taken from a patient, in this case, through a process called leukapheresis.

With these and other experiments underway, we are moving forward with our HIV cure strategy research. Your support enables us to determine how prostratin, which has long been identified as a prime player in an HIV cure strategy, affects the human body and targets HIV.

The below graph reflects HIV activation in cells after treatment with prostratin:

T-cell line activation
At 24 hours after exposure, HIV activation peaks, reverting to pre-treatment levels 96 hours (or 4 days) after treatment.

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