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to Section One | to Arts & Entertainment
posted Friday, January 15, 2016 - Volume 44 Issue 03
New once-a-week injectable HIV meds await FDA approval
Section One
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New once-a-week injectable HIV meds await FDA approval

by Mike Andrew - SGN Staff Writer

The pharmaceutical company CytoDyn has announced that it is awaiting FDA approval of a new once-a-week injectable HIV drug. The medication, called PRO 140, could also be used for pre-exposure prophylaxis (PrEP), the company said.

'[I]f PRO 140 is FDA approved, the infected person could finally take a break and go on a vacation without having to remember their pills, and the exact times to take them each day,' CytoDyn said in a press release.

'Upon FDA approval, all they will need is a gentle reminder to inject a weekly dose of PRO 140 every seven days.'

According to the company, of the 11 patients whose viral load was suppressed by PRO 140, all showed 'maximal virologic suppression' after at least one year on PRO 140. All 11 'patients substituted their daily highly active antiretroviral therapy (HAART) regimen with weekly, painless subcutaneous injections of PRO 140,' the company said.

'We are very pleased to report maximal virologic suppression with PRO 140 monotherapy in 11 out of 14 HIV-1 patients who are participating in this treatment-substitution study,' Jacob P. Lalezari, M.D., the principal investigator of the PRO 140 Phase 2b trial and extension study from Quest Clinical Research, said.

'The durability of the response to PRO 140 monotherapy over at least a one-year period is remarkable. In addition, PRO 140 appears well tolerated in all patients treated to date.'

CytoDyn says that PRO 140 belongs to a new class of HIV/AIDS therapeutics, called 'viral-entry inhibitors,' that are intended to protect healthy cells from viral infection.

PRO 140 is a monoclonal antibody directed against CCR5, a molecular portal that HIV uses to enter T-cells. The drug prevents HIV entry into human T-cells by masking the required co-receptor, CCR5. At the same time, PRO 140 does not appear to interfere with the normal function of CCR5 in healthy immune responses.

Because PRO 140 is an antibody and not a synthetic drug like other HIV meds, it 'has no apparent issues with toxicity,' the company says.

CytoDyn also found that PRO 140 did not induce the development of drug-resistant viruses in its previous short-term trials.

The company said its new drug might benefit patients who have difficulty adhering to daily drug regimens. In addition, they said, PRO 140 would be indicated for patients who find it difficult to tolerate existing meds, or who have complex medical issues due to compromised organ function or multiple drug-resistant viruses.

Final results from CytoDyn's 25-week Phase III FDA trial are expected by the end of the year.

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