Patients with CCR5-tropic HIV-1 have limited or no approved treatment options due to resistance or intolerance.
The treatment maraviroc is in a new class of investigational HIV drugs known as CCR5 antagonists, designed to work differently from currently available HIV/AIDS antiretroviral medicines. Rather than fighting HIV inside white blood cells, CCR5 antagonists prevent the virus from entering cells by blocking its predominant entry route, the CCR5 co-receptor.
“It is our hope that maraviroc, now in final stages of clinical development, may help those patients who have exhausted treatment options and are not already participating in our clinical studies,” said John LaMattina, president, Pfizer Global R&D.
Pending regulatory review, the program will begin enrolling patients in the next few months, with a target to enroll patients from over 30 countries. Pfizer confirmed plans to submit applications for marketing approval in both the US and EU following review of the data from two phase III trials.