A new treatment for a fatal liver disease could slash costs and save thousands of lives every year in Asia, Africa and South America, the World Health Organization said Monday.
The U.N. health agency said that three stages of clinical trials on 600 patients in India had shown the new drug cured 95 percent of cases of so-called "black fever."
The drug, miltefosine, originally was developed in the 1980s by German pharmaceutical company Zentaris during research on breast cancer treatments. In 1988, scientists discovered that it also affected the parasite that causes black fever.
After six years of joint research and trials by Zentaris, WHO and Indian authorities, India's drugs licensing body approved the drug in March for a fourth stage of field trials beginning in July. Zentaris chief executive Juergen Engel told reporters the company also would meet with Germany's drugs administration next month to discuss an application for European Union approval.
India is one of the nations hardest hit by the disease and has set a 2010 target date for its eradication through a government-funded program.
In a statement released by WHO, India's Health Minister C.P. Thakur,who suffered from the fever as a child and is a leading specialist on the disease, called the new drug a "breakthrough."
"This is a crucial weapon which is easy to handle by the physician in the rural areas," he said.
WHO tropical disease chief Carlos Morel said the development of the drug "was a case of those who had the problem working with those who had the solution."
Each year 500,000 people develop the disease, whose scientific name is visceral leishmaniasis, with most cases occurring in India, Nepal, Bangladesh, Sudan and Brazil. The disease, which can be fatal without treatment, kills around 60,000 people a year.
Visceral leishmaniasis, which is caused by a parasite spread by sand flies, attacks the liver and spleen, causing bouts of fever and severe weight loss. It strikes mainly poor people suffering from malnutrition and accelerates the onset of full blown AIDS in people infected with the HIV virus, said WHO.
The disease is related to leishmaniasis, a disfiguring and potentially fatal skin disease. Early trial results suggest leishmaniasis may also be cured by the new drug, said WHO.
Doctors trying to fight visceral leishmaniasis are facing a growing problem of drug resistance, said WHO. Up to 60 percent of patients in India cannot be cured with current treatments, which are given intravenously and require up to a month in a hospital.
The current treatments also can cause side effects such as diabetes or lethal reactions in 9 percent of cases.
But the 600 patients in the Indian trials, who were "moderately severe" sufferers of the disease, responded well, said WHO. The agency said 30 percent of those who had shown resistance to existing treatments were cured by the new drug.
The new drug, which kills the parasite, can be given orally without hospital visits, making it easier to reach more patients. Side effects were limited to mild vomiting for a few days, but not immediately after taking the drug.
Zentaris chief executive Juergen Engel told reporters it can cost up to $500 to cure a patient using current treatments, way beyond the health budget of many governments. A course of miltefosine would cost between $50 and 100, he said.
"We're prepared to make the necessary production available for additional numbers of the drug," Engel said, but refused to comment on whether Zentaris would provide the drug cheaply to WHO and developing nation governments.
Several drug companies are providing cut-price medicines to treat HIV/AIDS or disease such as tuberculosis, after coming under fire for charging amounts beyond the reach of most poor countries.