Potential Treatment for Severe Malaria Completes Phase I Study

2009-10-13

STOCKHOLM - October 13, 2009. Dilafor AB announces a significant milestone has been passed with the completion of a Phase I study for a potential new treatment for severe malaria. The recently completed Phase I study has proven that the new compound DF02 is safe and well tolerated. With this result, work towards developing this in to a new drug that can save lives can proceed.

Every minute two children die from malaria and more than 500 million people fall ill to malaria each year. Meanwhile, the number of patients suffering from severe malaria is estimated to increase in the near future. Today, there are no effective treatments against the most severe symptoms of malaria.

- A new drug of this kind can save many lives, says Professor Mats Wahlgren, MD at Karolinska Institutet and the Swedish Institute of Infectious Disease Control, and one of the founders of the drug development company Dilafor, a company within Karolinska Development.

Dilafor has completed a clinical phase I study with DF02, a new drug to be developed against severe malaria. The results prove that DF02 is safe and well tolerated in all of the tested dose levels at single dose and multiple dosing (nine doses during three days). In addition, the results show that the drug is suitable for intravenous injection, which is the only way to treat patients with the most severe form of malaria.

- We are happy with the outcome of this Phase I study. These results enable us to develop DF02 further and we will now prepare for the next clinical studies in Phase II. The potential drug DF02 shows great promise in solving the important medical need present in developing countries, but there is also an increasing need in the rest of the world, says Anders Åsell, CEO of Dilafor.

Severe anaemia, respiratory problems and encephalopathy are common and life-threatening consequences of serious malaria infection. The diseases are caused when the malaria parasite P. falciparium infects red blood cells, which then accumulate in large amounts, blocking the flow of blood in the capillaries of the brain and other organs. Dilafor is developing a new malaria treatment - DF02 - that reduces the blocking of the capillaries and also releases those blood cells that are already bound. The hope is that the treatment will normalize the blood flow.

The Phase I study was conducted during 2009 on 33 healthy men at Northwick Park Hospital in London, England. No severe adverse effects have been reported. Analyses of the pharmacokinetics and pharmacodynamics are currently taking place. The study was randomized, double blind, and placebo controlled.