LONDON, July 21, (Agencies): GlaxoSmithKline and its partner Shionogi are progressing a new drug against HIV into final-stage clinical testing, ramping up competition in a class of AIDS drugs known as integrase inhibitors.
The two drugmakers said on Wednesday they would be progressing the experimental medicine, S/GSK1349572, into Phase III clinical trials later this year, following promising results from two Phase IIb studies.
The decision to advance the drug comes one day before the release of the keenly awaited mid-stage clinical trial results on the medicine at the International AIDS Conference in Vienna.
Industry analysts believe ‘572 could reach the market in 2013, assuming it performs well in the next phase of testing.
Integrase inhibitors like ‘572 are designed to block genetic information needed for the human immunodeficiency virus (HIV) to reproduce and are seen as an important new weapon in the fight against AIDS.
Merck & Co already has an established integrase inhibitor drug called Insentress, which sold $752 million last year, and Gilead has a rival product currently in Phase III testing called elvitegravir.
But industry analysts believe Glaxo’s next-generation once-daily compound, which does not require a booster, may have an edge over rivals, with initial data suggesting it is highly potent and also has a superior resistance profile.
Success with ‘572 could signal the re-emergence of Glaxo as a significant player to rival Gilead in the HIV marketplace, according to Sanford Bernstein analyst Geoffrey Porges.
Glaxo was an early pioneer and long-time market leader in the HIV field but the British-based company has been overtaken in recent years by its smaller Californian rival, which has come to dominate the market due to its focus on convenient combination pills.
In a bid to fight back, Glaxo last year pooled its HIV assets with those of Pfizer to form a new joint company majority-owned by Glaxo, called ViiV Healthcare, with an eye on regaining market leadership.
The new compound ‘572 is the first of two similar integrase inhibitors being developed by ViiV.
For Gilead, it could represent a strong competitor for its new combination pills, including a four-in-one “Quad” tablet currently in Phase III that contains Gilead’s own integrase inhibitor elvitegravir.
Meanwhile, Glaxo will have the option of combining ‘572 with various other AIDS drugs, including its established product Combivir.
Glaxo was to report financial results for the second quarter at 1100 GMT. Gilead reported earnings on Tuesday.
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South African research that helped produce a promising anti-AIDS gel will change the nature of the fight against the disease, the head of the university that pioneered the research said Tuesday.
Malegapuru Makgoba, vice chancellor at the University of KwaZulu-Natal on South Africa’s east coast, described the project that created the vaginal gel as a “milestone” for impoverished women, policymakers and scientists in combatting the disease that has plagued the African continent for three decades.
“These research findings will not only significantly alter the shape and form but also the future direction of this devastating epidemic,” Makgoba told reporters in the port city of Durban, where most of the researchers are based.
South Africa, a nation of about 50 million, has an estimated 5.7 million people infected with HIV, more than any other country. It is the largest recipient of PEPFAR funds.
The researchers say the gel, known as a microbicide, can protect four out of ten women from HIV infection.
The gel, spiked with the AIDS drug tenofovir, cut the risk of HIV infection by 50 percent after one year of use and 39 percent after 2 1/2 years, compared to a gel that contained no medicine.
Additional results proved that the gel was effective in preventing 51 percent of genital herpes infections in women.
Scientists believe the cheap and easy-to-use gel could be useful for “women who are unable to successfully negotiate mutual faithfulness or condom use with their male partners,” said Dr. Quarraisha Abdool Karim, a leading researcher and co-director of the South African gel program.
She said young women in South Africa bore the brunt of HIV infection.
The study had asked nearly 900 women volunteers in rural areas around Durban to use a gel — some being dummy samples — up to 12 hours before sex and within 12 hours afterward.
At the end of the 30-month trial period, 60 of the 444 women who received dummy gel were infected with HIV while only 38 of the 445 women who used the tenofovir gel were HIV-positive, reflecting a reduction of nearly 50 percent of the HIV infection rate.
Meanwhile, for Xoli Mthethwa, an unmarried 26-year-old mother of one living in the village of Vulindlela, the first trial of an AIDS gel using a prescription drug was a matter of life and death.
Mthethwa was one of 889 women at high risk of infection who took part in the clinical trials of the new gel. The first results, released at an international AIDS conference in Vienna, show it can protect women from the deadly virus though not at the rates researchers had hoped for.
“Since males don’t like to use condoms and it is difficult for women to persuade them to use it, if this gel is successful it will help many women because they will not have to ask for permission to use the gel and many women will be able to protect themselves from HIV,” Mthethwa told Reuters from her home in the east coast of the country.
The gel can be used discreetly, offering women a chance for protection from sexual partners who refuse to wear condoms, which experts said is one of the drivers of the spread of HIV/AIDS on the continent.
Each participant needed to apply a first dose of the gel within 12 hours before sexual intercourse, with a second dose applied as soon as possible and within 12 hours afterwards.
Dr Karim at the University of KwaZulu-Natal in Durban and colleagues have been testing the gel for two-and-a-half years on two groups of women — city-dwellers in Durban and women like Mthethwa living in outlying villages.
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Campaigners on Tuesday lamented the fact that the female condom, just as effective as its male equivalent, has failed to gain the profile it deserves in the fight against AIDS.
“Women are tired of asking permission to save their own lives,” Serra Sippel, president of the Washington-based Center for Health and Gender Equity (CHANGE) told journalists at the World AIDS Conference.
In 2008, while 2.4 billion male condoms were distributed, the figure for female condoms was only 18.2 million, she said.
And in Sub-Saharan Africa, where 60 percent of adult males are HIV-positive, the female condom was available for only one in every 300 women.
“The female condom has been available for 15 years and for 15 years it has been joked about,” said Lucie van Mens, coordinator of another pressure group, Universal Access to Female Condoms (UAFC).
And yet, while shops sold any number of different variants for male condoms, she pointed out: “There is only one model available.”
It was time business started putting the same kind of imaginative marketing and design into the female condom to ensure women could find one that suited them, she argued.
Another fundamental problem was the cost, said Carol Nawina Nyirenda of CITAM+ — the Community Initiative for Tuberculosis, HIV/AIDS and Malaria.
Nyirenda, from Zambia, told reporters: “A female condom is 50 cents, compared to a male condom which is for one cent.”
For Jim Clarken of Oxfam, another issue central to promoting the female condom was about control.
“It’s also a key component to facilitate women having control over their own reproductive health,” he said.
Studies conducted by groups in Cameroon and Nigeria had shown “an incredibly high rate of acceptability of female condoms by both men and women,” he said.
As far back as 1997, a UN study conducted in 40 countries had registered acceptance levels of 96 percent.
And yet, said Clarken: “The public still knows very little about it.”
Female condoms were better received however when presented as a means of contraception or even a sex toy, rather than a way of protecting oneself from AIDS, said van Mens.
“It’s also important to give women the right to have fun with sex,” she added.
Delegates and journalists all received a sample female condom with the conference information pack — complete with detailed instructions.