PRO 140

Candidate Pre Phase 1 Phase 2 Phase 3

PRO 140

Pre-Clinical Phase completed
Phase 1 completed
Phase 2 in progress
Phase 3 not started

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 humanized monoclonal antibody directed against CCR5, a molecular portal that HIV uses to enter cells.



PRO 140 has certain unique attributes that distinguish it from other therapies designed to block HIV entry. PRO 140 is an antibody, not a drug and has no apparent issues with toxicity. Laboratory studies have shown that PRO 140 does not induce the development of resistant viruses. PRO 140 does not affect the normal function of CCR5, it only blocks the precise site on CCR5 that HIV needs to enter the cell without affecting the normal function of CCR5.

PRO 140 is one of the most advanced experimental monoclonal antibodies for HIV treatment and has been used in approximately 100 HIV-infected subjects in placebo controlled FDA-approved clinical trials. PRO 140 has been the subject of four Phase 1/1b and two Phase 2a clinical trials, each of which demonstrated PRO 140’s ability to significantly reduce HIV viral load in human test subjects, and has also been designated a “fast track” product candidate by the United States Food and Drug Administration. The PRO 140 antibody appears to be a powerful antiviral agent while not being a drug, leading to potentially fewer side effects and less frequent dosing requirements as compared to daily drug therapies currently in use

We believe that PRO 140 may have a number of potential roles in the treatment and prevention of HIV including:

  • Patients with multi-drug resistant viruses
  • Patients with difficulty adhering to daily drug regimens
  • Patients who poorly tolerate existing therapies
  • Patients with compromised organ function, i.e., HCV co-infection
  • Patients with complex concomitant medical requirements
  • Pre-exposure (PrEP) or post-exposure (PEP) prophylactic in high risk seronegative individuals

HIV remains a significant global health issue. With limited new drugs in development around the world, CytoDyn believes that monoclonal antibodies are poised to become the next class of anti-viral agents on the market for the treatment of HIV.

CytoDyn is focused on developing monoclonal antibodies for the treatment of HIV infection and disease and is excited to continue the clinical trial development of PRO 140 for HIV.