Australian pharmaceutical company StarPharma announced Tuesday that the Food and Drug Administration has granted fast-track status to VivaGel, an investigational microbicidal gel that women would apply vaginally in the hours before intercourse to prevent transmission of HIV and genital herpes.
Microbicide gels provide an additional weapon in the fight against AIDS where condom use is not socially acceptable.
"Topical microbicides just makes it a lot easier for women," said Anthony Fauci, director of the National Institute of Allergy and Infectious Disease at the National Institutes of Health, which recently awarded $20 million to StarPharma to speed the development of VivaGel. "It gives them a degree of control," Fauci told UPI. "They're important because of the relationship between the HIV pandemic and women's ability to protect themselves in societies that don't allow them that freedom."
Indeed, in some cultures, he said, women are physically attacked for demanding that their partner use a condom, but even in the United States, women who would like to use a condom may face pressure not to.
Jackie Fairley, StarPharma's chief operations officer, agreed that, despite extensive education programs, the use of condoms is very low.
"This is different from condoms because it does not require the cooperation of a sexual partner," Fairley told UPI.
In a safety study of 35 Australian women, the drug was found to have no harmful side effects. Now that the company has secured FDA fast-track status, the drug will move on to larger efficacy studies this year and eventually to a population-based study at a number of global centers, including sites in Africa and Asia, she said.
If the trials go smoothly, the gel could be ready for marketing by 2008.
There are currently 240,000 AIDS or HIV-infected women in the United States, and it is the leading cause of death among African-American women between ages 25 and 34.
Worldwide, 40 million people -- and 17.5 million women -- have HIV or AIDS.
Genital herpes, also caused by a virus, is a non-lethal but incurable sexually transmitted infection that affects an estimated 50 million Americans.
The microbicidal agents in VivaGel called dendrimers prevent transmission of disease by blocking the ability of a virus to bind to human cells, the mechanism by which people become infected with HIV and herpes.
Microbicides can be formulated as gels, creams, sponges, suppositories or films with the purpose of reducing the incidence of sexually transmitted infections. They can afford protection for varying periods, from several hours up to days, or can be designed to have a contraceptive function.
Although the product is initially being developed for use by women, the same virus-inactivating technology could also be used for men, Fairley said.
"We think ultimately this will be broadly used by young adults to protect themselves," she said.
The compounds used in microbicide gels are similar to anti-retroviral drugs and therefore could be manufactured at a cost affordable to women in poor countries who constitute the largest group of AIDS victims worldwide, according to NIH's National Institute of Allergy and Infectious Disease.
A November 2005 study published in the scientific journal Nature found that a microbicide gel containing three anti-viral agents -- made by three different drug companies -- prevented infection from a virus similar to HIV in macaque monkeys, even as many as six hours after it was applied.
The FDA's fast-track program is designed for drugs that meet a pressing public health need and can cut the time it takes for new drugs to reach consumers by as much as half. Developers of drugs with fast-track status can consult directly with the FDA about trial design, and portions of the new drug application can be submitted before the entire application is completed.
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