Breakthrough Anti-Malaria Drug Begins Tests

by Gustavo Capdevila

(IPS) GENEVA -- Clinical trials of a new anti-malaria drug will begin before the end of the year in Thailand, representing faster than expected progress in one of several scientific research efforts aimed at combatting a deadly disease that affects 500 million people and claims up to two million lives a year.

The drug, OZ277/RBx11160 (nicknamed Oz), is currently being evaluated in a Phase I study, which consists of administering different doses to healthy volunteers to establish its safety, tolerability and pharmacokinetics, the study of what the body does to a drug.

Phase II, in which patients will be injected with the experimental drug, had originally been scheduled to begin early next year, but will be moved up to the last quarter of 2004, scientific researcher Carl Craft, with Medicines for Malaria Venture (MMV), told IPS.

The synthetic drug has properties similar to those of a plant known as sweet wormwood (Artemesia annua), which has traditionally been used in China to treat fevers.

"Although artemisinin-based combination therapies (ACTs) are currently the best cure for drug- resistant malaria, access to ACTs in disease endemic countries has been limited due to their cost," say MMV and Ranbaxy Laboratories Limited of India, which are jointly developing the new drug.

The aim is to produce a synthetic drug that would not be dependent on the artemesia plant and would make it possible to offer a much less expensive medicine to markets in poor countries, because it would be cheaper to manufacture.

The progress made by MMV and Ranbaxy is just one of the positive examples of efforts by non-profit organizations in the past five years to develop medicines and vaccines against diseases primarily found in poor countries -- an area of research and development (R&D) of little interest to large laboratories in the developed world.

Such efforts form part of the Initiative on Public-Private Partnerships for Health (IPPPH), an alliance between United Nations agencies and private donor foundations.

Moving in the same direction, but without contributions from private donors, the Drugs for Neglected Diseases Initiative (DNDi) is also developing anti-malaria medication, known as Fixed-dose Artesunate Combination Therapy (FACT), which combines two drugs into one tablet.

The DNDi, an independent non-profit organization, is carrying out clinical trials in the West African nation of Burkina Faso using a compound combining artesunate (an artemisinin derivative) and amodiaquine, for use in Africa.

The organization is also conducting clinical trials in Thailand of a tablet that combines artesunate with mefloquine, for use in Asia and Latin America.

The different ingredients used are due to the fact that certain substances are more potent and obtain better results in one specific population than in another, DNDi spokeswoman Jaya Banerji explained to IPS.

The results of the research are expected by late 2005, she added.

The parasites that cause malaria -- a febrile illness produced by sporozoan parasites, transmitted by the bite of the female Anopheline mosquito -- have become increasingly resistant to the older anti-malaria drugs like chloroquine, said DNDi director Bernard Pecoul.

Due to the dearth of simple diagnostic methods in poor countries, many people are erroneously treated for malaria when they do not actually have the disease, which only increases drug resistance, said Pecoul.

The DNDi was created in July 2003 on the initiative of the international organization Medecins Sans Frontieres (MSF), in partnership with the Oswaldo Cruz Foundation of Brazil, the Indian Council of Medical Research, Institut Pasteur, the Malaysian Health Ministry and the Kenya Medical Research Institute.

The Geneva-based DNDi notes that other initiatives to research and develop drugs for neglected diseases focus mainly on malaria, tuberculosis and HIV/AIDS -- diseases that are also present in rich countries or in nations in which there is a market for tourists.

These efforts "have relied heavily on market-based incentive mechanisms, including public-private partnerships," the organization adds.

The DNDi, on the other hand, urges governments to assume greater responsibility with regards to the "most neglected diseases," like sleeping sickness, Chagas disease or leishmaniasis, which tend to affect the extremely poor, who will never represent an attractive market for pharmaceutical companies.

Banerji said that in November, DNDi will begin trials in Africa for a drug against visceral leishmaniasis or kala-azar, which claims around 60,000 lives a year in Africa.

The kala-azar parasite, which is transmitted by sand flies, causes symptoms like fever, anemia and a swollen spleen. The main drug used to treat the disease for the past 70 years is painful, toxic, costly and has dangerous side-effects. In addition, it is running into parasite resistance.

The organizations experimenting with new drugs or treatments for illnesses generally associated with poverty have recently been making progress, said Roy Widdus, with IPPPH.

But the success of such initiatives, which can save millions of lives in developing countries, requires additional funding of at least one billion dollars from here to 2007, he added.

The funds are needed to finance R&D into essential medicines and vaccines, said Widdus, who presented a report Thursday on the results of the first investments -- totalling around two billion dollars -- in the field of neglected diseases in the past few years.