News (Updated August 27,
2006)
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Fri Aug 25, 5:29 AM ET
A commonly used HIV medicine may also help prevent cervical cancer and could be developed into an anti-cancer cream, early laboratory tests by British scientists suggest.
Researchers at the University of Manchester said on Friday that test-tube studies showed the drug lopinavir selectively killed human papilloma virus (HPV) -- the virus that causes cervical cancer -- as well as HIV.
Lopinavir belongs to a class of HIV drugs known as protease inhibitors. It is a key component of Abbott Laboratories Inc's best-selling pill Kaletra.
Dr Ian Hampson and his colleagues in Manchester believe lopinavir could eventually be made into a simple cream or pessary, offering an alternative to surgery for women with precancerous lesions.
No clinical trials have yet commenced, however.
Results of the team's early research will be published in next month's issue of the journal Anti-Viral Therapy and will also be presented at the International HPV meeting in Prague on September 5.
Merck & Co Inc and GlaxoSmithKline Plc have both developed ground-breaking vaccines to prevent strains of HPV that cause most cases of cervical cancer.
But Hampson said not all women would be vaccinated and not all lesions would be prevented by the new shots, leaving a role for non-surgical therapies such as his team's proposed cream.
Story from BBC NEWS:
US scientists say they have discovered how HIV evades the body's natural defences against viral infections.
HIV disarms the T cells sent by the body to fight it by flicking a molecular switch on the cells.
In the laboratory, the researchers were able to block this switch and restore T cell function, Nature reports.
Drugs are already available that can do the same, but the scientists say more safety studies are needed.
The drugs may not be specific enough and could cause nasty side-effects, they cautioned.
Lead researcher Bruce Walker, a Howard Hughes Medical Institute researcher at Massachusetts General Hospital in the US, said: "One has to proceed with real caution because if you turn back on an immune regulatory switch that the body has decided to turn off, you could trigger serious immunological problems."
The T cell switch controls a pathway of cellular events called programmed death-1 or PD-1.
The US researchers, working with colleagues at the Doris Duke Medical Research Institute in Durban, studied blood samples from 71 people who had recently contracted HIV but who had not yet commenced anti-HIV treatment.
They also looked at samples from four HIV-positive individuals taken before and after they had begun antiretroviral therapy.
HIV appeared to turn the T cell switch off, triggering the inhibitory PD-1 pathway.
"Turn off"
Furthermore, higher PD-1 expression was associated with more severe functional impairment of T cells.
PD-1 expression dropped when HIV treatment began, however. Blocking the PD-1 pathway restored T cell function.
He said the next step would be to see if the T cells can be turned back on in HIV-infected people in a way that will benefit them without incurring any serious side effects.
The researchers are also exploring whether PD-1 measurements could be used to guide treatment.
Dr Walker said: "Currently, we just count the number of T cells to decide when to treat someone, but we are excited about the possibility that adding PD-1 measurement might tell us more about the likelihood of progression of the disease and need for treatment in infected people."
Roger Pebody, treatment specialist for the UK's Terrence Higgins Trust, said: "This study is promising, and we hope that it will help researchers develop new therapies that may be available over the next decade."
A spokeswoman from the international HIV and Aids charity AVERT said: "This research is certainly encouraging, and fills another gap in scientists' knowledge about how HIV functions.
"However, as the researchers themselves say, further trials and studies are needed before we can hope to turn this knowledge into a new therapy for HIV, particularly if there is a risk of triggering any sort of auto-immune disease in the individual concerned."
Wed Aug 23, 12:03 PM ET
Theratechnologies Inc. said on Wednesday the U.S. Food and Drug Administration has agreed to a design for a major clinical trial of a drug to combat a side-effect of taking anti-HIV drug combinations.
In a statement, Montreal-based Theratechnologies said it had received a special protocol assessment from the FDA, which involves guidance and evaluation on a clinical trial design for Phase 3 tests of the company's TH9507 drug. Phase 3 tests are a stage in development prior to seeking approval for marketing a drug.
Theratechnologies' TH9507 drug is designed to treat lipodystrophy, usually considered to be a side effect of using anti-HIV drug combinations and characterized by a swollen belly along with loss of face, arm and leg tissue.
"We view this (special protocol assessment) as insurance against some of the regulatory risks associated with our Phase 3 program," Yves Rosconi, the company's president and chief executive, said in a statement.
"The SPA tells us that our development strategy is on target and continues to meet regulatory requirements in the U.S.," he added.
The first 412-patient clinical trial of TH9507 began in June 2005 and patient enrollment at 43 clinical sites across North America was completed on schedule in March 2006.
Results from the first trial are expected at the end of the year. The company said it plans for a new Phase 3 trial to start in the first quarter of 2007.
The company's shares jumped 8 Canadian cents to C$1.62 on the Toronto Stock Exchange in unusually brisk volume, bucking a 0.1-percent retreat by the market's benchmark index.
Sat Aug 26, 1:32 PM ET
US pharmaceutical firm Gilead is set to sell its AIDS-fighting tenofovir drug in Thailand at a price about 90 percent cheaper than in the United States and Europe, activists have said.
Thailand's Food and Drug Administration approved tenofovir for sale at about 38 baht (one dollar) per tablet, and should be available next month, the AIDS Access Foundation said.
"The new drug would be a good alternative for AIDS patients, especially those who have become resistant to GPO-Vir, which is made by the Government Pharmaceutical Organisation," the foundation's director Nimit Tienudom told AFP.
The number of people growing resistant to the drugs already produced locally is growing by about 10 percent a year, he said.
Thailand is also testing the drug as part of "morning after" prophylaxis treatment for people who believe they were exposed to HIV to prevent the virus from taking hold, he added.
The drug must be taken in combination with two other medications, and the total cost of the treatment may still prove prohibitive for poor Thai patients at about 2,700 baht (73 dollars) a month, Nimit said.
GPO-Vir is priced at 2,500 baht a month, for two tablets taken daily, but the price may fall, he added.
Of the 600,000 Thais with HIV, about 80,000 are receiving treatment. Some 18,000 new cases were reported last year.
Thailand's treatment program has been widely credited with slashing the number of deaths from AIDS by about 75 percent last year.
British pharmaceutical firm GlaxoSmithKlein, which introduced the drug Combid to Thailand four years ago, earlier this month dropped its controversial application to patent a key AIDS drug in Thailand and India.
The AIDS Access Foundation said the medication did not merit a patent because it merely combined existing drugs into one tablet and did not constitute a new invention.
Thailand's Government Pharmaceutical Organization has produced and distributed its own generic version of Combid at one-fifth the price for years.