MDS Pharma Services Helps to Fight Malaria

Malaria – a deadly disease spread by infected mosquitoes – is the focus of Phase III clinical trials being managed by the Global Clinical Development division of MDS Pharma Services (www.mdsps.com), a leading provider of drug discovery and development solutions headquartered in King of Prussia, Pennsylvania.
Of all the mosquito-borne diseases, malaria is perhaps the best known. Hippocrates, as far back as 400 BC, was probably the first scientist to study and characterize malaria. Today, malaria is still a devastating disease, killing more people than it did 30 years ago. Although a large number of malaria cases can be prevented, or at least identified and cured, the U.S. Centers for Disease Control and Prevention reports that between 350 and 500 million clinical episodes of this disease still occur every year, fueled by malaria’s growing resistance to existing drugs. The “G8” -- eight countries that account for about two-thirds of global economic output – have called malaria one of the “neglected diseases” that “undermine growth and exacerbate poverty in developing countries.” Nearly 40 per cent of humanity, chiefly pregnant women and children under 5, are at risk for malaria. A child dies of malaria every 30 seconds, and the disease kills one to three million people each year.

MDS Pharma Services is managing an ongoing Phase III trial of a first-line treatment against malaria: Eurartekin™ or “Artemisinin Combination Therapy” (ACT).
Developed by Italian company Sigma-Tau, Eurartekin is generated from two chemicals called piperaquin and dihydroartemisinin, the latter derived from the traditional Chinese Artimisia herb, a medicine with a 2000-year history. Eurartekin is especially potent against malaria because it acts rapidly and is well tolerated. The fact that this treatment is a combination drug both reduces the chances of resistance and improves its efficacy. No treated malaria cases have shown resistance to artemisinin so far. The World Health Organization (WHO) now recommends ACT treatment for drug-resistant malaria. Many countries in sub-Saharan Africa and Asia have adopted it as their preferred malaria treatment.

2500-patient anti-malarial trial

MDS Pharma Services is now studying Eurartekin in more than 2500 malaria patients throughout China, Laos, India, Thailand, Burkina Faso, Kenya, Mozambique, Uganda, and Zambia. These malaria drug trials are being performed on behalf of an international public and private collaboration of four groups: Sigma-Tau, a leading pharmaceutical company based in Italy; the non-profit Medicines for Malaria Venture (MMV, part of the WHO); China's Chongqing Holley pharmaceutical company; and Oxford University. Dr. Carl Craft, Chief Scientific Officer of MMV in Geneva, Switzerland, praised this anti-malaria drug research, saying, “This is a pivotal study. For MMV, it will be the first major Phase III study conducted with so many patients across Africa and Asia. It will set the standard for conducting clinical trials in malaria-endemic countries. MDS Pharma Services is an important partner, and we have full confidence that the appointed team will manage the Phase III trials and ensure that strict GCP standards are followed.”

Professor Nick White of Oxford University adds: “Dihydroartemisinin and piperaquine could become a major weapon against malaria. We hope the large Phase III trial currently underway will confirm that it is safe and effective, and also easy to use and well tolerated. With the easy once-a-day regimen for three days and the low cost, it could potentially have widespread use and save many lives.”

MDS Pharma Services International Project Director Jo Hudson notes, “MDS Pharma Services is honored to have been chosen to conduct this study with world renowned experts such as Professor Nick White of Oxford University and Professor Umberto D'Allesandro of the Institute of Tropical Medicine in Antwerp. Our involvement in this effort to find affordable and effective treatments for malaria in developing countries supports the MDS commitment to make a distinctive contribution to the health and well-being of people.”