Since 2007 Dilafor AB documents the development of DF02 against severe malaria. Dilafor is now launching the selected International Nonpropretary Name (INN) sevuparin sodium, by World Health Organization (WHO), sevuparin sodium. Dilafor has reported positive results from a phase I study performed with sevuparin sodium in healthy adult individuals. A Phase II study is now being prepared and will be performed in adults with malaria in Asia or Africa.
International Nonproprietary Names (INN) are selected by WHO and facilitate the identification of pharmaceutical substances. Each INN is a unique name that is globally recognized and is public property. A nonproprietary name is also known as a generic name.

Partnering objectives

Dilafor’s principal objective is to seek an arrangement for tafoxiparin with a single partner who would undertake to develop, gain regulatory approval and ultimately market and sell tafoxiparin on a worldwide basis.

Partnering process & further contacts

Fredrik Henell & Co AB (“FHCO”) has been retained as Dilafor’s exclusive advisor in conjunction with the partnering process. Should you have an interest in receiving additional information, including arranging a management presentation, please contact FHCO:

Dr Fredrik Henell
Tel: + 46 70 325 38 47
Email: f.henell@telia.com

At an extra shareholders meeting on December 17, Bengt Å Johansson and Eva Sjökvist Saers have been elected as new members of the board. Bengt has long experience from Astra and AstraZeneca, from commercialisation, strategic development and transaction of products and projects. Eva has long experience from academic research and has held leading positions at AstraZeneca in drug development. Eva is the Managing Director of Apoteket Produktion & Laboratorier, a subisidiary of Apoteket AB (APL). APL  develops and manufactures special products (extemporaneous and stock preparations) to the healthcare sector and offers contract services to companies in Life Science. Eva is also the chairman of the Swedish Academy of Pharmaceutial Sciences.
At the following constituent board meeting Bengt was elected as chairman for Dilafor after Per Giléus.

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. 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.

For more information, please contact:
Anders Åsell, CEO Dilafor
+46 8 5248 47 20
anders.asell@dilafor.com

Mats Wahlgren, MD, Professor
+46 8 5248 72 77
mats.wahlgren@ki.se

DF02 in brief:
DF02 is derived from heparin. After a chemical conversion DF02 acquires characteristics similar to that of low molecular weight heparin (LMWH) but with minimal effect on anticoagulation and bleeding. Positive effect on severe malaria of heparin has previously been observed in a number of smaller studies.

The anticoagulation effect is not desired in connection with treatment of malaria due to the increased risk of bleeding. Since the mechanism that reduces the symptoms of severe malaria is assessed to be independent from the effect on anticoagulation, DF02 has been developed to meet this requirement.

The clinical study in brief:
Double-blind: Neither treated person nor the investigators have any knowledge of who belongs to the control group or to the trial group during the trial. Randomized: Patients are allocated at random between the control and the trial group. Placebo-controlled: Trial results are compared with results from individuals that have been treated with a substance with no medical effect, i.e. the control group.

Dilafor in brief:
Established in 2003, Dilafor AB is a Swedish R&D company focused on developing pharmaceutical products from heparin derivatives with low anticoagulant activity. The company has a balanced product portfolio representing highly promising ideas and innovations. Each of the projects addresses important and unmet medical needs.

Dilafor successfully finalized a Phase I clinical study in the project DF02, a drug candidate for the treatment of severe malaria. The project, tafoxiparin (DF01) for protracted labor, successfully concluded a clinical Phase II study in July, 2009.

Dilafor is managed by senior staff with high academic credentials and extensive industrial experience gained from key areas of pharmaceutical development. The company is located at Karolinska Institutet Science Park and is part of Karolinska Development.

Karolinska Development in brief:
Developing one of the largest portfolios of life science research companies in Europe, Karolinska Development AB is a new type of company focused on filling the innovation gap within the pharmaceutical industry. Using a unique, highly cost-effective model Karolinska Development commercializes internationally renowned life science innovations, helping to deliver the medical products of the future.