EANS-News: SYGNIS Pharma AG SYGNIS Announces Key Results of its Phase II Trial
of AX200 in Acute Ischemic Stroke
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Research & Development
Heidelberg (euro adhoc) - SYGNIS Announces Key Results of its Phase II Trial of
AX200 in Acute Ischemic Stroke
* The Study missed its endpoints
Heidelberg, 15 December 2011 - SYGNIS Pharma AG (Frankfurt: LIOK; ISIN
DE000A1E9B74; Prime Standard) today announces key results of the Phase II
clinical trial (AXIS 2) of AX200 to treat acute ischemic stroke. The key results
on the relevant primary endpoint, using the modified Rankin Scale (mRS), and
secondary endpoint, using the National Institutes of Health Stroke Scale
(NIHSS), show no improvement in patient outcome relative to the placebo-treated
patient. As a result, the study missed its endpoints.
The primary endpoint of significant functional improvement according to mRS
evaluated AX200 treated patients relative to placebo-treated patients. The study
recorded no clinical improvement and did not show any statistically significant
difference. The secondary endpoint of improvement using the NIHSS relative to
placebo-treated patients did also not record a clinically relevant or
statistically significant difference.
Clinical Mean* Relative p-value
Parameter (95% Conf. Interval) Difference*
AX200 Placebo
(n=160) (n=163)
mRS 3.31 3.12 0.19 0.30
(3.06 - 3.56) (2.87 - 3.37) (-0.17 - 0.55)
NIHSS 8.88 8.45 0.43 0.61
(7.70 - 10.07) (7.28 - 9.62) (-1.24 - 2.10)
*adjusted for pre-specified baseline characteristics
SYGNIS Pharma will continue to analyse the current data set and the new data
that will become available in the weeks ahead. Full data will be available in Q1
2012.
The randomized, double-blind AXIS2 trial enrolled 328patients in 78centers
throughout Europe. Patients enrolled into AXIS 2 had to meet basic inclusion
criteria of treatment within nine hours after stroke onset; ischemic stroke in
the MCA territory confirmed by MRI; an NIHSS recording of 6 - 22 and stroke size
of more than 15cm3.
"We are very disappointed about the outcome of the study and will have to
analyse the full data set in order to fully understand these results, which are
not in line with our previous findings. Although the patient group treated with
AX200 on average showed a slightly more severe infarct; this does, however, not
explain why we could not see any relevant differences between the two groups
regarding the patient outcome ", said Dr. Frank Rathgeb, Chief Medical Officer
of SYGNIS Pharma AG.
For further information please contact:
SYGNIS Pharma AG
Dr. Franz-Werner Haas
Senior Vice President Operations
SYGNIS Pharma AG
Tel: +49 6221 454 812
Email: franz-werner.haas@sygnis.de
Media & Investors
Raimund Gabriel
Partner
MC Services
Tel: +49 89 210 2280
Email: Raimund.Gabriel@mc-services.eu
About SYGNIS Pharma AG
SYGNIS Pharma AG (Heidelberg, Germany) is a specialty drug development company,
focusing on innovative treatments for underserved human diseases. The company's
current lead program, AX200, has completed a large Phase II efficacy trial to
treat acute ischemic stroke. In the field of cognitive disorders, the company is
exploring compounds targeting the KIBRA pathway, a novel approach to treating
different forms of dementia. With AX200 and the KIBRA program SYGNIS is defining
unique approaches to treating these very common diseases. There is great medical
demand for new treatments as there are currently no or only inadequate options
available. SYGNIS Pharma AG is listed on the Prime Standard of the Frankfurt
Stock Exchange under the ticker: LIOK; and ISIN: DE000A1E9B74.
About AX200
AX200 is an endogenous protein (G-CSF), which - as part of the body's own
protective action- is boosted after brain damage.
About the Modified Rankin Scale
The modified Rankin Scale (mRS) is a commonly used scale for measuring the
degree of disability or dependence in the daily activities of people who have
suffered a stroke. The scale has become the most widely used clinical outcome
measure for stroke clinical trials. The scale runs from 0 to 6 - from perfect
health without symptoms to death (six).
About the National Institutes of Health Stroke Scale
The National Institutes of Health Stroke Scale (or NIHSS) is a method developed
to gauge the severity of a stroke. The score has a range between 0 and 42, the
higher the score the greater the deficiencies the patient has. Zero indicates
the patient is free of symptoms.
#Disclaimer
Some statements included in this press release, relating neither to proven
financial results nor other historical data, should be viewed as
forward-looking, i.e. not definite. Such statements are mainly predictions of
future results, trends, plans or goals. These statements should not be
considered to be total guarantees since given their very nature they are subject
to known and unknown risks and imponderability and can be affected by other
factors as a consequence of which the actual results, plans and goals of SYGNIS
Pharma AG may deviate greatly from the established conclusions or implied
predictions contained in such statements. SYGNIS does not undertake to publicly
update or revise these statements in the light of new information or future
results or for any other reason.
Further inquiry note:
Michael Wolf
Telefon: +49 (6221) 454 - 6
E-Mail: Michael.Wolf@sygnis.de
end of announcement euro adhoc
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company: SYGNIS Pharma AG
Im Neuenheimer Feld 515
D-69120 Heidelberg
phone: +49 (0)6221 454-6
FAX: +49 (0)6221 454-777
mail: contact@sygnis.de
WWW: http://www.sygnis.de
sector: Biotechnology
ISIN: DE000A1E9B74
indexes: CDAX, Prime All Share
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Hamburg, Stuttgart, Düsseldorf, Hannover, München
language: English