Announcement no. 24/2007
To the OMX Nordic Exchange Copenhagen, November 29,
2007
Curalogic is ready to commence a clinical study with the house dust mite product
Summary: Curalogic has received all necessary permissions to start a Phase II
clinical study (DME 01) with the product for the treatment of house dust mite
allergy. The market for Curalogic's house dust mite product is large as about 52
million people in Europe and 30 million people in the United States suffer from
house dust mite allergy.
Curalogic has obtained permission from the German regulatory authorities (the
Paul Ehrlich Institute) and the “Landesamt für Gesundheit und Soziales Berlin”
(the ethical committee of Berlin) to start a Phase II clinical study (DME 01)
with the product for the treatment of house dust mite allergy.
The study objective is to test the tolerability of escalating doses of orally
administered house dust mite extract to patients suffering from house dust mite
allergy. According to the plan, 30 patients will participate in the study, which
will be conducted at a single clinical centre in Berlin, Germany. It is expected
that the first patients will be dosed before Christmas 2007, and the results
from the study are scheduled to be published in the third quarter of 2008.
Design of the clinical study
DME 01 is a double-blinded, randomized, placebo-controlled study, with the
primary objective to
determine the maximum tolerated dose, i.e. the highest dose that can be
administered without too many side effects. A secondary objective will be to
evaluate the safety of the house dust mite product. Patients with moderate to
severe house dust mite allergy will be treated daily with escalating doses of
house dust mite extract. The dose level will be increased every week after a
thorough safety evaluation at the previous dose level.
Curalogic's product for the treatment of house dust mite allergy
The program targets registration both in the United States and Europe. The two
most predominant house dust mite species in the United States and Europe are D.
pteronyssinus and D. farinae. The active ingredients in the product for treating
allergy to house dust mites will therefore comprise a mixture of extracts of
these two species of house dust mites.
House dust mite allergy
About 52 million people in Europe and 30 million people in the United States
suffer from house dust mite allergy. Patients suffering from allergy to house
dust mites have allergy symptoms year round.
Yours Sincerely,
Curalogic A/S
For additional information, please contact:
Peter Moldt, President and CEO, Phone +45 99 99 24 00, mobile +45 26 25 04 22
Helle Busck Fensvig, EVP and CFO, Phone +45 99 99 24 00, mobile +45 20 70 55 37
About Curalogic
Curalogic is a Danish biopharmaceutical company listed on the OMX Nordic
Exchange (CUR.CO) as a small cap + company. Curalogic develops innovative
products for the treatment of allergy using a patented formulation technology.
The products combine the efficacy of immunotherapy with the patient friendliness
of antihistamines and have the potential to become the preferred type of allergy
treatment among patients. Curalogic has a broad and mature pipeline of products
for the treatment of ragweed allergy and grass allergy in Phase III, and
products for the treatment of house dust mite allergy and cat allergy in Phase
II.
This announcement contains forward-looking statements regarding the Company's
future financial development and performance and other statements which are not
historical facts. Such statements are made on the basis of assumptions and
expectations which, to the best of the Company's knowledge and belief, are
reasonable, at this time, but may prove to be erroneous in the future.
Curalogic is ready to commence a clinical study with the house dust mite product
| Source: Curalogic A/S
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