Press Release, December 06, 2007: In a first long
term controlled double-blind study (CALIPSO), lisuride sc infusion therapy
has proved highly effective in reducing severe motor complications in
patients with advanced Parkinson’s Disease (PD) refractory to optimized
oral therapy.
CALIPSO has been the first double-blind controlled study of a sc
continuous infusion of a dopamine agonist in complicated advanced PD. In
this study 66 PD patients (average age 62 years, 44 % females) with about
10hours of severe motor fluctuations (“off” + “troublesome dyskinesia”)
have been treated in a double blind core phase of the study over 6 weeks.
Lisuride subcutaneous (sc) infusion was compared with optimized oral
dopamine agonist therapy (ropinirole, pramipexole, cabergoline). Patients
in the lisuride group received lisuride infusion + oral placebo - the
control group received their pre-study oral dopamine agonists + placebo
infusion. All other anti-Parkinson therapy including L-Dopa was kept
constant. After finishing the core phase 49 patients (~75%) have chosen to
continue lisuride sc infusion in the extension phase over 2 years.
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In the efficacy results, lisuride sc infusion proved significantly
superior to the oral dopamine agonists in better mobility (UPDRS III motor
score) and less troublesome dyskinesias (UPDRS IV A dyskinesia score) in
the same patients. Statistically significant improvement was also obtained
in Clinical Global Impression (CGI) and Responder Rates, thus confirming
the results from a previous open controlled study over 4 years (Stocchi et
al. Brain 2002). A mean reduction of 4 hours (from ca 10 h at baseline) in
“Off” and in “troublesome dyskinesia” (prim. endpoint) based on patient
diaries was observed under lisuride sc therapy after 6 weeks treatment
which came close to the 0,05 level of significance. Spontaneous day-to-day
fluctuations might have a marked influence on the patients´ diary
documentation whilst the clinical evaluation of PD symptoms is not
affected.
In patients with complicated late stage PD who had been diagnosed
refractory to optimized oral combination therapy, the CALIPSO results
constitute a remarkable improvement which will be validated by further
efficacy data during the extension phase and another confirmatory study in
preparation.
The results obtained (see figures) are evidence that lisuride sc infusion
fully replaces a maximum oral dopamine agonist therapy and improves at the
same time motor function as well as dyskinesias without change in
concomitant levodopa therapy. In the extension phase, the dose of levodopa
can be gradually reduced.
No new safety-relevant findings have been reported. Local tolerance of the
lisuride sc infusion was good.
These results from the CALIPSO study as a whole confirm the strong
efficacy and good tolerability of lisuride sc infusion in patients with
treatment-resistant advanced PD compared to oral dopamine agonists (i.e.
continuation of previous therapy) under double-blind conditions. A similar
significant improvement in motor function and at the same time in
dyskinesias without any modification of the levodopa dosage has not been
described for any non-invasive drug therapy in a comparable population of
patients with severe PD.
About Lisuride sc Infusion
Lisuride sc is indicated for the treatment of patients in an advanced
stage of Parkinson´s Disease refractory to conventional oral
Anti-Parkinson therapy. This continuous application of a parenteral
dopamine agonist using a small portable minipump provides stable drug
levels and thereby achieves superior therapeutic results in
treatment-resistant stages of Parkinson´s Disease complicated by motor
fluctuations.
Today the concept of continuous dopaminergic stimulation which mimics the
physiological profile of activation by substantia nigra neurons, is
favoured for the therapy of Parkinson´s Disease.
About Axxonis Pharma AG, Berlin
Axxonis Pharma AG, Berlin, is a pharmaceutical company specialized on
CNS products. Axxonis is developing a portfolio of internally discovered
or licensed product candidates to improve the therapeutic benefits of
existing drugs and develop the products for indications of higher value.
Axxonis’ most advanced product candidate, the lisuride patch, is the
subject of a Phase III clinical program for the treatment of RLS which has
now been completed successfully. Axxonis has also reported positive
results from a Phase III clinical trial of transdermal lisuride (as
separate brand) in patients with advanced Parkinson’s Disease. Axxonis is
also committed to the development and marketing of the parenteral
application form of lisuride for continuous dopaminergic stimulation
(CDS).
To learn more about Axxonis, please visit the website at
www.axxonis.com.
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Forward-Looking Statements
This press release contains "forward-looking" statements, including,
without limitation, all statements related to our clinical development
program with lisuride and the timing thereof; the potential filing of a
NDA with lisuride; the therapeutic and commercial potential; potential
milestone and royalty payments; and future commercialization plans. These
forward-looking statements are based upon Axxonis' current expectations.
Forward-looking statements involve risks and uncertainties. Axxonis'
actual results and the timing of events could differ materially from those
anticipated in such forward-looking statements as a result of these risks
and uncertainties, which include, without limitation, the ability of the
company to successfully conduct the clinical trials, the uncertainty of
the EMEA approval process and other regulatory requirements, the
therapeutic and commercial value of the company's products and issues
relating to regulatory approval, manufacturing and commercialization,
Axxonis expressly disclaims any obligation or undertaking to release
publicly any updates or revisions to any forward-looking statements
contained herein to reflect any change in the company's expectations with
regard thereto or any change in events, conditions or circumstances on
which any such statements are based.
Axxonis is a registered
trademark.
Axxonis Pharma AG
Schöneberger Str. 15
10963 Berlin
Germany
Phone: +49(0)30-2693429-0
Fax: +49(0)30-2693429-22
Websites: www.axxonis.com
and www.lisurid-cds.de
Email: info@axxonis.com
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