euro adhoc: Sygnis Pharma AG / other / SYGNIS announces successful completion of the clinical IIa study for AX200 in stroke (AXIS)

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Research & Development

22.07.2007

Heidelberg, July 22nd, 2007 - SYGNIS Pharma AG has successfully
completed the clinical phase IIa-study (AXIS) in stroke. AXIS was a
multicenter, doubleblind, placebo-controlled dose escalation study.
The comprehensive analysis of the study data showed that the primary
and secondary endpoints have been achieved and that the use of AX200
in stroke patients can be considered to be safe.

Although the focus of the AXIS-study was the collection of data
regarding safety and tolerability, data regarding the efficacy of
AX200 were also monitored. Due to the small number of patients
involved in such a safety study, a significant difference between
AX200 and placebo treated patients could not be observed in the
overall consideration of the usual clinical endpoints. However, a
detailed statistical evaluation of the data provided hints that
certain stroke patients may benefit from a treatment with AX200.

AX200 for the treatment of acute stroke is the most advanced drug
candidate in SYGNIS´ product pipeline. Besides stroke, SYGNIS is
currently preclinically testing the endogenous protein AX200 in
further neurodegenerative indications such as Amyotrophic Lateral
Sclerosis (ALS).

With the positive results of the AXIS study the path has been cleared
for the further clinical development of AX200. SYGNIS is now in the
process of designing and preparing the phase IIb trial whose aim will
be to demonstrate the efficacy of AX200 in stroke patients.

###Except for the historical information contained herein, the
matters set forth in this press release are forward looking. These
forward-looking statements may include projections, assumptions,
estimates, targets, and descriptions of future events. Such
statements are based on currently available information and on
SYGNIS´ current expectations as to future events that may not prove
to be accurate. These statements are not guarantees of future
performance and involve risks and uncertainties that are difficult to
predict. Many factors could cause the actual results, performance or
achievements of SYGNIS to be materially different from those that may
be projected, expected, targeted, expressed or implied by such
statements. ###

end of announcement euro adhoc 22.07.2007 15:41:40
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ots Originaltext: SYGNIS Pharma AG
Im Internet recherchierbar: http://www.presseportal.de

Further inquiry note:
Dr. Franz-Werner Haas
Vice President Operations
Telefon: +49(0)6221 454-812
E-Mail: franz-werner.haas@sygnis.de

Branche: Biotechnology
ISIN: DE0005043509
WKN: 504350
Index: CDAX
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