Ranbaxy Laboratories Malaria Drug Was Effective, Safe in Mid-Stage Trial

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Wednesday, August 25, 2010

By Simeon Bennett

An experimental malaria drug developed by Ranbaxy Laboratories Ltd. was effective and safe in a mid-stage clinical trial, according to a study that suggests the treatment may offer an alternative to current medicines.

Among 230 people with the deadliest form of malaria in Thailand, India and Tanzania, Ranbaxy’s arterolane cleared the disease in as many as 72 percent of patients within 28 days, researchers led by Neena Valecha at India’s National Institute of Malaria Research wrote in the Sept. 15 edition of the journal Clinical Infectious Diseases.

The study is part of an effort to find new malaria drugs as treatments derived from artemisinin, the basis of the most powerful medicines, show signs of losing power in Southeast Asia, jeopardizing global efforts to curb the mosquito-borne disease. Arterolane may provide an alternative to artemisinin-based drugs because it’s not derived from plants and can be produced at greater quantities, the study said.

“There is an urgent need to develop new alternative drugs,” Valecha and colleagues wrote. “A fully synthetic drug such as arterolane, which has an activity profile similar to that of the artemisinins, provides an important potential in such an endeavor.”

Third-Deadliest

Malaria strikes about 250 million people each year and kills more than 880,000, mostly children under 5 in Africa, according to the World Health Organization. It’s the world’s third-deadliest infectious disease, with only AIDS, which results in about 2 million deaths each year, and tuberculosis, which kills 1.6 million people annually, more lethal, the Geneva-based WHO said.

A study published in the New England Journal of Medicine last year showed drugs derived from artemisinin took almost twice as long to clear the parasites that cause the disease in patients in western Cambodia as in patients in northwestern Thailand.

“Arterolane is indeed one of the new drugs we are very keen to test against artesunate-resistant malaria on the Thai- Cambodian border,” said Arjen Dondorp, a researcher at the Mahidol Oxford Research Unit in Bangkok who led the Cambodian research.

Valecha and colleagues tested three doses of arterolane in patients between 13 years and 65 years. Each patient received one dose a day for seven days. The drug worked fastest and most powerfully at the highest dose, the study said. The most common side effects were headache, vomiting and abdominal pain.

The disease reappeared in as many as 37 percent of patients after treatment, showing it would need to be combined with less powerful, slower-acting drugs to ensure patients are cured. Ranbaxy is now studying arterolane in combination with an older drug, piperaquine, in a late-stage patient study in India, Bangladesh and Thailand, according to the Gurgaon, India-based company’s website.

The trial was funded by the Geneva-based Medicines for Malaria Venture.

To contact the reporter on this story: Simeon Bennett in Singapore at sbennett9@bloomberg.net

 

©2010 BLOOMBERG L.P.

Source: Bloomberg

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