Dilaforette initiates a Phase I/II study with Sevuparin for the treatment of severe malaria

STOCKHOLM - September 23, 2011. Dilaforette, part of the Karolinska Development
portfolio, today announced that the first patient has received a dose of
Sevuparin in a Phase I/II study. This is the first time that Sevuparin will be
tested in malaria patients. The study is conducted in uncomplicated falciparum
malaria patients with safety as the primary objective. In the next step efficacy
in severe malaria patients will be tested. A total of 98 patients is planned to
be included in the trial which will be conducted in Thailand together with the
Mahidol Oxford Research Unit (MORU) in Bangkok. MORU is a collaboration between
Mahidol University and the University of Oxford sponsored by the Wellcome Trust
of Great Britain.


Pirkko Sulila Tamsen, CEO, Dilaforette
"I am delighted to announce that the first malaria patient has been included for
treatment with Sevuparin. We have great hopes to turn our malaria research
programs into new treatment policies to the benefit of patients suffering from
severe malaria.  We are pleased to have Prof Arjen Dondorp at MORU as the
coordinating principal investigator in our study. Prof Dondorp was the principal
investigator for AQUAMAT, the largest ever antimalarial drug trial in severe
malaria. AQUAMAT was published in the Lancet 2010 together with Prof Nick White
and Prof Nick Day, both world leading experts in the field of malaria research."

Prof Arjen Dondorp, Coordinating Principal Investigator, Department Head and
Deputy Director of the MORU
"Although it is still early days I have high expectations of Sevuparin which
interferes with the pivotal culprit in malaria pathophysiology, which is
blockage of the smallest blood vessels in vital organs. It could help to reduce
mortality in cases of severe malaria where potent antimalarial treatment alone
is not sufficient."

There are 250 million malaria cases per year resulting in close to one million
deaths, mostly children. Despite optimal antimalarial treatment, 10 to 30
percent of the patients with severe malaria die. Sevuparin is a potential new
adjuvant treatment of severe malaria that acts by preventing and reversing the
infected cells' ability to block blood vessels.

Torbjörn Bjerke, CEO, Karolinska Development
"We believe that Dilaforette has found both an excellent way to fast
implementation of the clinical development program as well as access to clinical
expertise which will enable this potential lifesaving treatment to reach
clinical proof-of-concept in malaria patients with a big medical need."


For further information, please contact:
Pirkko Sulila Tamsen, CEO, Dilaforette
Phone: +46 (0)70 302 95 88, e-mail: pirkko.tamsen@dilaforette.se

Torbjörn Bjerke, CEO, Karolinska Development
Phone: +46 (0)72 744 41 23, e-mail: torbjorn.bjerke@karolinskadevelopment.com



TO THE EDITORS

About Dilaforette
Dilaforette is a Swedish drug development company developing Sevuparin, a
heparin analogue for the treatment of severe malaria. Infection caused by the
Plasmodium falciparum parasite frequently gives rise to severe malaria in non-
immune humans. Infected erythrocytes have a tendency to bind and block the
capillaries in many of the vital organs. The main cause of disease severity and
pathology is through hampered blood flow and reduced oxygen delivery which
results in tissue damage. It is based on the ability of parasite infected
erythrocytes to adhere to the vascular endothelium (cytoadherence) and to
uninfected erythrocytes (rosetting). Heparin is known to block these processes
and has been tried as an adjunctive treatment in severe malaria but was
discontinued due to an increase in bleeding complications related to the
anticoagulant effects. Sevuparin is a heparin analogue where the anticoagulant
activity of the parent molecule has been drastically reduced but the ability to
prevent and reverse infected cells' ability to block blood vessels.


About Mahidol - Oxford Tropical Medicine Research Unit (MORU)
The MORU supported by the Wellcome Trust began in 1979 as a research
collaboration between the Faculty of Tropical Medicine, Mahidol University and
the University of Oxford. The main research interests are the epidemiology,
diagnosis, pathophysiology and treatment of malaria, scrub typhus, melioidosis,
leptospirosis and other tropical infections which impose a substantial disease
burden on rural populations throughout this populous region. Research from MORU
has contributed importantly to the current WHO guidelines on the treatment of
severe and uncomplicated malaria, including artesunate for severe malaria and
artemisinin combination therapy (ACT) for uncomplicated disease.



About Karolinska Development
Karolinska Development aims to create value for investors, patients, and
researchers by developing innovations from world class research into products
that can be sold or out-licensed with high returns. The business model is to:
SELECT the most commercially attractive medical innovations; DEVELOP these to
the stage where the greatest return on investment can be achieved; and
COMMERCIALIZE the innovations through the sale of companies or out licensing of
products. This will result in upfront payments, milestone payments and
royalties.

An exclusive deal flow agreement with Karolinska Institutet Innovations AB,
along with other cooperation agreements with leading Nordic universities,
delivers a continuous flow of innovations.

Karolinska Development's flexible exit strategy enables projects to be exited at
whichever stage of development offers the greatest return on investment, usually
after Phase II clinical trials have indicated the desired pharmaceutical effect
on patients - this being an important value enhancing step.

Today, the portfolio consists of over 35 projects at various stages, from
concept development to Phase II clinical trials, twelve projects are in clinical
trials. The portfolio is particularly strong in the areas of cancer,
dermatology, inflammation, cardiovascular disease, women's health and diseases
that affect the central nervous system. www.karolinskadevelopment.com


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