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Pregnant with HIV? PRO 140 Can Reduce Side Effects of Meds

Monday Dec 21, 2015

The NIH recently reported that pregnancy-related changes in the body can affect how the body processes the HIV medicines it takes. Because of these bodily changes, the prescribed dose of HIV medicine may also change during pregnancy.

"This means that the correct script to keep a pregnant woman's HIV viral load in check, and her side effects under control, will no doubt be subject to change. These changes that the NIH is predicting could only breed confusion to those looking to get pregnant not knowing if the new scripts will work or not," said Nader Pourhassan, CEO, CytoDyn Inc., clinical developer of PRO 140. "The recommended dose of daily HIV meds is known to bring on nausea, vomiting, headache, fever, muscle pain, occasional dizziness. Pregnancy has similar side effects. They may double now that there are both non-effective HIV meds and pregnancy issues involved."

CytoDyn's Phase 2b FDA trial had a 98 percent success rate. Now in Phase 3 FDA trial, CytoDyn hopes to have PRO 140 commercialized by 2017. PRO 140 belongs to a new class of HIV/AIDS therapeutics -- viral-entry inhibitors -- that are intended to protect healthy cells from viral infection. PRO 140 is a fully humanized IgG4 monoclonal antibody directed against CCR5, a molecular portal that HIV uses to enter T-cells. PRO 140 blocks the predominant HIV (R5) subtype entry into T-cells by masking this required co-receptor, CCR5.

Importantly, PRO 140 does not appear to interfere with the normal function of CCR5 in mediating immune responses. PRO 140 does not have agonist activity towards CCR5 but does have antagonist activity to CCL5 which is a central mediator in inflammatory diseases. PRO 140 has been the subject of seven clinical trials, each demonstrating efficacy by significantly reducing or controlling HIV viral load in human test subjects. PRO 140 has been designated a "fast track" product candidate by the FDA. The PRO 140 antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements as compared to daily drug therapies currently in use.

"But, pregnant women could soon have an option: choose the often toxic pill regimen, the accepted method to fight HIV, or once FDA approved, PRO 140, the new proven self-injected antibody that offers a more comfortable experience with almost no side effects. One dose a week, or possibly (in future) one dose a month, of PRO 140 injected in each thigh treats the infection completely suppressing the viral load. When the morning sickness, and other annoyances of early pregnancy fade away, the HIV infected woman-with-child could return to a fairly normal life," concluded Pourhassan.

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