DGAP-News: PAION REPORTS POSITIVE PRECLINICAL RESULTS OF ITS SUBSTANCE SOLULIN IN THE INDICATION HAEMOPHILIA
(firmenpresse) - DGAP-News: PAION AG / Key word(s): Research Update
PAION REPORTS POSITIVE PRECLINICAL RESULTS OF ITS SUBSTANCE SOLULIN IN
THE INDICATION HAEMOPHILIA
06.12.2010 / 07:30
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PAION REPORTS POSITIVE PRECLINICAL RESULTS OF ITS SUBSTANCE SOLULIN IN THE
INDICATION HAEMOPHILIA
- New approach for the treatment of haemophilia
- PAION initiates the next development steps
- Flovagatran will not be pursued
Aachen (Germany), 06 December 2010 - The biopharmaceutical company PAION AG
(ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8) today
announces positive preclinical data with its recombinant human
thrombomodulin Solulin in the indication haemophilia.
Haemophilia is an inherited disorder in which blood clotting is disturbed.
The lack of the clotting factors VIII or IX leads to prolonged bleeding
after injuries or bleeding with the risk of associated complications.
In a series of experiments it was demonstrated, that Solulin is also able
to stabilize the haemostatic fibrin clot at significantly reduced factor
VIII or factor IX levels. Hence, the potential exists for its use as a
supplement to factor VIII or IX. Expected benefits include a reduction in
the dose of clotting factors and prolonged effectiveness. The proof of
principle was shown in different experimental paradigms. Blood was taken
from haemophilia patients and the clotting ability of such blood was
examined, using standard methods, with and without Solulin. Low
concentrations of Solulin resulted in improved clotting capacity.
Encouraging experiments were also carried out with blood from haemophilic
dogs. The activity of Solulin was also demonstrated in the presence of
inhibitors in dogs (antibodies to factor VIII that block the activity of
the coagulation factor).
Before entering clinical development in haemophilia, advanced pre-clinical
experiments and a new production batch of Solulin are planned. The
available phase I data with Solulin reveal an excellent tolerability in
healthy volunteers. For the time being PAION will invest limited resources
in Solulin.
Solulin and Flovagatran were originally developed as potential therapies
for thrombotic diseases. Through the recent approvals of oral
anticoagulants, injectable substances in this class have lost much of their
appeal. Therefore, already in 2008, PAION initiated a new evaluation of
both products in niche indications.
The positive data on Solulin in an attractive indication have also led to a
new priority within the development pipeline of PAION. After weighing the
commercial and clinical success probability it was decided not to proceed
with the development of Flovagatran, as a promising indication could not be
identified. In the current quarter this results in an impairment off the
book value of EUR 0.2 million.
'These findings with Solulin are encouraging and experts see the results as
a promising basis for further development. We regard haemophilia as an
attractive niche indication and Solulin will address a high unmet medical
need with a new therapeutic approach' commented Dr. Wolfgang Söhngen, CEO
of PAION. 'In addition to Remimazolam, we managed to bring this exciting
project, significantly forward. We are happy to conclude an important and
successful year for PAION AG with this positive result.'
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About haemophilia
According to WHO worldwide currently about 400,000 people are affected by
the hereditary disease of haemophilia, including 10,000 in Germany.
Therefore, the definition of an 'orphan disease' is fulfilled.
Worldwide, the number of treatable patients with haemophilia increases
steadily. Currently, haemophilia is treated mainly by the administration of
recombinant or plasma derived factor VIII and factor IX products to
normalize the increased tendency to bleed. Solulin has the potential to
improve the existing treatment options for patients suffering from
haemostatic coagulation.
Haemophilia is an inherited disorder in which blood clotting is disturbed.
The lack of the clotting factors VIII or IX lead to prolonged bleeding
after injuries or bleeding with the risk of associated complications.
Particularly and frequently affected are the joints of children. Other
complications can be life threatening. Besides the lack of the relevant
clotting factor, the premature dissolution of haemostatic fibrin clots
contributes to the clinical pathophysiology. Today the treatment
essentially consists of substituting the missing clotting factor.
About Solulin
Solulin is an improved variant of the human protein thrombomodulin, an
important natural regulator of the clotting system. One of the functions of
thrombomodulin is to stabilize the initial fibrin clot to stop bleeding.
Other than native thrombomodulin which is anchored in the wall of blood
vessels, Solulin can enter the blood stream to reach its potential site of
action.
Solulin already has been successfully tested in a Phase I study. The
specific coagulation tests confirmed the good safety profile of the
substance.
About PAION
PAION is a biopharmaceutical company headquartered in Aachen, Germany and
has a second site in Cambridge, UK. The company is specialized in
developing and commercializing innovative drugs for the hospital-based
treatment in indications for which there is a substantial unmet medical
need. PAION has a 'Search&Develop' business model, which is based on its
core expertise in drug development. Where appropriate, particularly during
the late stages of the clinical development, PAION seeks to collaborate
with experienced partners.
Contact
Ralf Penner
Director Investor Relations / Public Relations
PAION AG
Martinstrasse 10-12
52062 Aachen - Germany
Phone: +49 241 4453-152
E-mail: r.penner(at)paion.com
www.paion.com
Disclaimer:
This release contains certain forward-looking statements concerning the
future business of PAION AG. These forward-looking statements contained
herein are based on the current expectations, estimates and projections of
PAION AG's management as of the date of this release. They are subject to a
number of assumptions and involve known and unknown risks, uncertainties
and other factors. Should actual conditions differ from the Company's
assumptions, actual results and actions may differ materially from any
future results and developments expressed or implied by such
forward-looking statements. Considering the risks, uncertainties and other
factors involved, recipients should not rely unreasonably upon these
forward-looking statements. PAION AG has no obligation to periodically
update any such forward-looking statements to reflect future events or
developments.
End of Corporate News
06.12.2010 Dissemination of a Corporate News, transmitted by DGAP - a
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Language: English
Company: PAION AG
Martinstr. 10-12
52062 Aachen
Deutschland
Phone: +49 (0)241-4453-0Fax: +49 (0)241-4453-100
E-mail: info(at)paion.com
Internet: www.paion.com
ISIN: DE000A0B65S3
WKN: A0B65S
Listed: Regulierter Markt in Frankfurt (Prime Standard);
Freiverkehr in Berlin, Düsseldorf, Hamburg, München,
Stuttgart
End of News DGAP News-Service
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105513 06.12.2010
Datum: 06.12.2010 - 07:30 Uhr
Sprache: Deutsch
News-ID 32794
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