PLWHAs Can Find Better Adherence Through PRO 140 Injectable

According to a recent government report, only 52 percent of Americans were taking the antiretroviral medication for HIV, resulting in a widespread lack of recommended care. Since each infected patient has a different viral load, their infection level determines the medications prescribed. As a result, each has their own pill regimen.

Another government report states that those with HIV/AIDS can have a particularly difficult time taking their medications-as-prescribed because:

a) It may be hard to remember which drug (pill) needs to be taken at a particular time

b) Sometimes, the side effects make the infected person feel worse instead of better

c) When the patient feels okay, they don't have the 'physical reminder' to take the medications. Thus, they may not feel the need to take their drugs (pills)

d) People may not be aware of the risks of drug resistance that can occur if they stop treatment or skip or lower doses

e) When doses are skipped or stopped strains of HIV may develop that are resistant to the meds and even to some medications not yet prescribed

f) Fewer treatment options may result should the patient need to change treatment regimens in the future

Currently in Phase 3 FDA trials, there is a solution that can help the 48 percent using the above excuses not to take their HIV meds.

"Ask your friends with HIV if they had a choice would they rather take multiple pills with the inherent problems and accumulation of toxicity, or inject an antibody that is toxic-free and has no side effects or complaints from users in clinical studies," said Nader Pourhassan, PhD, CEO CytoDyn Inc.. "In fact, PRO 140, the first self-injectable antibody, has documented an impressive 98 percent success rate in a Phase 2b clinical trial for patients with HIV. This means their viral load was kept at suppressed level without pills. This gave them a chance to have a quick return to a normal life."

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.

"When PRO 140 is finally approved by the FDA, only one simple sub-coetaneous dose a week will be needed to keep the viral load in check. Future studies could allow patients to take PRO 140 once every two weeks or maybe once a month. When the HIV community has a choice of meds, it will most likely find PRO 140 to be quite a positive difference from the arduous daily pill regimen," said Pourhassan.