WASHINGTON, Feb. 8 (UPI) -- It's being billed by some as a miracle preventative, a medical Next Big Thing on the level of the polio vaccine and penicillin: a vaginal gel or cream that gives women real power in protecting themselves from contracting the HIV virus through sex, particularly women who currently have little power, like many in AIDS-ravaged sub-Saharan Africa.
But the heady potential of the new treatment -- known as microbicide, now in early testing -- is colliding with the hard realities of finding enough patients willing to take part in clinical trials and attracting the pocketbooks of Big Pharma, signaling a challenging road ahead.
But academic groups, patient advocates and Capitol Hill lawmakers are hopeful and say they will forge ahead to try to have a topical, microbicide-based treatment for women on worldwide markets in five to 10 years.
If researchers can develop an anti-HIV topical gel that is even 60-percent effective, it could potentially prevent 2.5 million HIV infections in its first three years, experts say.
And according to some health experts, there is no time to lose.
"People tend to under-estimate how difficult it is for women to have control in sexual interactions," Helene Gayle of the Bill and Melinda Gates Foundation, which is funding some of the microbicide testing in Africa, said at a news briefing in Washington.
Women in Third World countries especially face longstanding cultural attitudes that leave them with little or no ability to protect themselves from contracting HIV through sex, and condoms are simply not an option, she said.
Current methods to protect women from the virus "are irrelevant in the lives of many women," Gayle noted.
For example, in Africa -- where females ages 15 to 24 are 2.5 times more likely to be infected than their male counterparts -- women are often economically dependent on men, are raised to believe that "pleasing men" is their main role in life, are forced into marriages in their early teens or are victims of sexual trafficking, Gayle told the conference.
But the disease is also spreading rapidly among U.S. minority women, with AIDS now the leading cause of death among African-American women, who have 19 times the infection rate of white women, she added.
"There is an urgent need for HIV preventative tools," Gayle said. "A colorless, odorless gel or cream is what we hope for" so female users "don't have to negotiate condom use."
To that end, there are currently five large-scale trials of microbicides under way in 10 African countries, with each expected to take three to five years, she said.
However, Gayle stressed that it is still too early to tell how effective this first generation of microbicides will be.
And answering that question carries a big price tag, Gayle noted. It will take about $260 million a year for the next five years "to give us the best shot of getting a product to market fastest," she estimated.
The health group Conrad is also overseeing a microbicide study spanning five countries -- including India and the African nations Uganda and Benin -- that currently enrolls 800 women but could expand to include 2,600 patients.
Conrad's mission is not only to move the testing forward, but also to drum up interest in the novel treatment among drug companies, Conrad Executive Director Henry Gabelnick told United Press International.
"We hope ultimately there will be enough private-sector sales to give companies the incentive to want to be involved," he said.
Gabelnick said his group is currently shopping for a manufacturing and marketing partner for Canada-based Polydex, the holder of the microbicide technology being studied in the Conrad-led trial.
He added that his group is scanning India for a potential licensee/manufacturer/distributor of the technology, or for a possible partner on a combination treatment incorporating the technology.
Gabelnick said Conrad was rebuffed by Johnson & Johnson about a possible deal several years ago, but added promising data from the microbicide studies could coax the drug giant back to the table.
He also said Conrad recently acquired the non-exclusive rights to HIV-specific anti-virals from Biosyn -- Savvy and UC781 -- which he said could be potentially used in a range of HIV prophylactics for women, including sponges and foaming tablets.
Aside from answering the costly questions of whether microbicides will work and in what form, there remains the challenge of recruiting study patients in countries where there has been a historical mistrust of clinical trials, health officials said at the briefing.
But the reluctance to enroll is not limited to the Third World, said U.S. Rep. Danny Davis, D-Ill., a member of the Congressional Black Caucus and lead co-sponsor of the Microbicide Development Act.
"People will bash me at public meetings if I suggest they take part in clinical trials," he told reporters. Davis said his bill -- currently before a House subcommittee -- currently has just 38 sponsors, but added it could draw as many as 100.
Davis said microbicides could have a "tremendous impact" among African-Americans. "If we continue the pursuit (for microbicide funding) we'll be able to rejoice in the victory."
But for now, women worldwide are losing the fight against the lethal virus.
Women account for nearly 60 percent of current global HIV cases. And with microbicides the most promising weapon in the battle to prevent new infections, it will take a major investment in early testing and in clinical trials, said the Gates Foundation's Gayle. "Women's lives hang in the balance."
