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New HIV therapy to be fast-tracked

Published on 15/02/07 at 11:28am

A new treatment for HIV is to be fast-tracked in Europe and the US.

Pfizer's new compound maraviroc is to receive an accelerated review - a process only granted to medicines that can demonstrate potential improvements over current therapies.

The FDA will review the drug in late April and if eventually approved, it will be the first in a new class of HIV/Aids treatments, known as CCR5 antagonists. A European review is expected around the same time.

Rather than fighting HIV inside white blood cells, CCR5 antagonists prevent the virus produced by infected cells from entering uninfected cells by blocking its predominant entry route, the CCR5 co-receptor.

The discovery of maraviroc goes back 10 years, when Pfizer research scientists at the company's R&D headquarters in Sandwich, Kent, designed the molecule. They found that around 1% of Europeans who lacked the genes for CCR5 receptors were the very ones resistant to acquiring HIV infection.

John LaMattina, president of Pfizer's global R&D department, said: "There is a profound global need for new medicines to help HIV/Aids patients. We expect that CCR5 antagonists like maraviroc will become critically important new treatment options for patients who are resistant or intolerant to their current HIV/Aids therapies."

Dr Ethan Weiner, Pfizer's global R&D vice president, commented: "Maraviroc is an outstanding example of rapid development and continuous innovation through which researchers quickly translated a scientific hypothesis into a promising compound in this area of great medical need."

If recommended, patients who are deemed suitable to take maraviroc will be able to combine it with another new class drug, Merck's integrase inhibitor MK-0518, which has shown impressive results in patients who have not responded well to current treatments. The product is currently in phase III trials.

In September 2006, Beatriz Grinztejn, head of the infectious disease service at the HIV/Aids unit at the Oswaldo Cruz Foundation, Rio de Janeiro, told the American Society of Microbiology that MK-0518, when combined with other therapy, was well-tolerated in patients who failed to respond to or were resistant to existing antiretroviral therapies.

Around 40 million people are currently infected with HIV/Aids worldwide, and it is estimated that four million new infections occur globally every year.

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