PAION SEES CONTINUED DEVELOPMENT RATIONALE FOR
DESMOTEPLASE BASED ON FINDINGS FROM PHASE III ANALYSIS
Reasons identified for high placebo response rate
in Phase III stroke study DIAS-2
Aachen (Germany), 18 October 2007 – PAION AG (Frankfurt Stock
Exchange, Prime Standard: PA8) today reported that it has reviewed findings
from the analysis of the DIAS-2 (Desmoteplase in Acute ischemic Stroke)
study results. In contrast to previous Phase II studies, the DIAS-2 study did
not meet its primary efficacy endpoint due to a lack of improvement in the
Desmoteplase groups over placebo. Therefore, the clinical efficacy of
Desmoteplase as demonstrated in two smaller Phase II studies (DIAS and
DEDAS) could not be confirmed. However, the analysis of the patient
subgroups has generated new findings regarding the unexpectedly high
placebo rate observed in the DIAS-2 study and provides indications for the
efficacy of Desmoteplase, although short of any statistical significance due to
the small patient numbers of the subgroups.
From the study's top-line results, it was already known that patients in the
DIAS-2 study showed on average relatively mild symptoms of stroke. Now
angiographs have been evaluated as part of the analysis. The data reveal that
in contrast to DIAS and DEDAS, a high percentage of DIAS-2 patients did not
have a blood clot in the main brain arteries at the start of treatment, despite
the detection of salvageable brain tissue (penumbra) surrounding the infarct
core according to the DIAS-2 study protocol. So far, stroke experts have
assumed the presence of a penumbra to be a key indication of both visible (in
the larger brain arteries) and non-visible blood clots (in smaller arteries). The
new findings are crucial since Desmoteplase’s main mechanism of action is to
dissolve blood clots in occluded arteries.
Consequently, the high percentage of DIAS-2 patients lacking a blood clot in
their main brain arteries seems to be a major reason for the similar clinical
outcome across the different dose groups including placebo.
In addition, findings from patient subgroups with a detectable blood clot in
their main brain arteries indicate that Desmoteplase could potentially show
efficacy compared to placebo. In particular, the efficacy of the drug seemed to
increase with the severity of the vessel occlusion. However, these findings
have to be confirmed in a larger patient group in order to achieve statistical
significance.
The latest findings from DIAS-2 are currently being discussed with leading
stroke experts in order to optimize the design of potential new trials.
"We have identified probable reasons for the unexpectedly good outcome in
the placebo arm as well as variables that will help optimize patient selection"
state Prof Dr Werner Hacke and Anthony J. Furlan, MD, chairmen of the
DIAS-2 Steering Committee. "Therefore, we see a scientific rationale to move
on to the next study."
PAION's Chief Executive Officer Dr Wolfgang So¨hngen comments: "We
believe that these findings provide a sound development rationale for
Desmoteplase. Following positive feedback from our investigators, the key
issue to be addressed in the near future is to secure sufficient funding and to
implement the latest findings into the design of future trials. This has to be
based on an assessment of potential patient benefit and the commercial
opportunity from a revised program with Desmoteplase.”
The analysis was carried out under the lead of PAION. In August 2007,
PAION's former partner Forest Laboratories, Inc. has decided to return all
rights to Desmoteplase under its sub-license agreement for North America.
PAION's partner H. Lundbeck A/S is currently evaluating the findings from the
analysis.
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Conference Call
On Thursday, 18 October 2007 at 2 p.m. CEST (1 p.m. BST, 8 a.m. EDT)
PAION will host a public conference call during which the latest findings in the
DIAS-2 data analysis will be discussed. Participants may dial +49 69 2222
2220 (Germany), +44 20 7138 0839 (UK) or +1 718 354 1362 (USA). Please
enter 2904733 as participant pass code. The conference call will be
conducted in English. To allow for smooth processing we suggest that you dial
in 10 minutes before the beginning of the call. The conference call will be
recorded. A replay will be available starting approx. 2 hours after the call until
end of day 20 October 2007. The dial-in details for the replay will be published
after the conference call on our website www.paion.de/investors.
About Desmoteplase
Desmoteplase, the most fibrin-specific plasminogen activator known today, is
a genetically engineered version of a clot-dissolving protein found in the saliva
of the vampire bat Desmodus rotundus. It has received fast-track designation
from the U.S. Food and Drug Administration for the indication of acute
ischemic stroke.
About DIAS-2
The DIAS-2 (Desmoteplase in Acute Ischemic Stroke) study was designed to
investigate the improvement of clinical outcome in patients with acute
ischemic stroke treated with Desmoteplase within 3 to 9 hours after onset of
stroke symptoms. Among other criteria, the detection of salvageable brain
tissue (penumbra) of at least 20% compared to the infarct core was applied for
including patients in the study. The blinded, randomized, placebo-controlled,
dose-ranging Phase III study was jointly conducted by PAION and Forest and
enrolled a total of 186 patients in Europe, USA, Canada, Australia, Hong Kong
and Singapore.
About Stroke
Stroke is the third leading cause of death in the industrialised world and a
leading cause of serious, long-term disability. In the US alone, 700,000 people
suffer a stroke each year, and around 20% of them die within four weeks.
For the US, the American Heart Association expects the financial burden of stroke
due to in-hospital costs, long-term care programs and productivity losses to
exceed 62 billion dollars in 2007 alone.
About PAION
PAION is a biopharmaceutical company based in Aachen, Germany (listed at
Frankfurt Stock Exchange, Prime Standard, ISIN DE000A0B65S3). It aims to
become a leader in developing and marketing innovative drugs for the
treatment of stroke and other thrombotic diseases for which there is a
substantial unmet medical need.
Contact
Dr Peer Nils Schroeder, Investor Relations / Public Relations
PAION AG
Martinstrasse 10-12
52062 Aachen – Germany
Tel. +49 241 4453-152
E-mail pn.schroeder@paion.de
www.paion.de |
