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Santhera Presents Data from 2-Year Open-Label Intervention Study with Catena® in Duchenne Muscular Dystrophy at the MYOLOGY 2011 Conference
Santhera Pharmaceuticals Holding AG /
Santhera Presents Data from 2-Year Open-Label Intervention Study with Catena® in
Duchenne Muscular Dystrophy at the MYOLOGY 2011 Conference
. Verarbeitet und übermittelt durch Thomson Reuters ONE.
Für den Inhalt der Mitteilung ist der Emittent verantwortlich.
Liestal, Switzerland, May 9, 2011 - Santhera Pharmaceuticals (SIX: SANN)
announced today that it will present first analyses of the 2-year open-label
study (DELPHI-E) evaluating Catena® for the treatment of Duchenne Muscular
Dystrophy. The findings indicate that Catena® can slow the decline in
respiratory function associated with patients as they age. Data will be
presented on May 9, 2011 in Lille, France at the 4th International Congress of
Myology [1].
Following a 12-month, randomized, placebo controlled Phase II trial (the DELPHI
study), participants were offered enrollment in a 24-month open-label study
(DELPHI-E). The 19 subjects in the DELPHI-E study received weight-adjusted doses
of Catena® at 450/900 mg/day for body weight of below/above 45 kg. Efficacy was
assessed as change from baseline for respiratory function tests, e.g. peak
expiratory flow (PEF), forced vital capacity (FVC) and maximum inspiratory mouth
pressures (MIP). On average, patients did not receive Catena® for 21 months
between the end of the DELPHI study and their enrollment into the DELPHI-E
study. During this period, a noticeable decline in PEF, FVC and MIP was
observed. Despite the patients' higher age, the rate of decline was numerically
lower for PEF and MIP when patients received Catena® treatment during the
DELPHI-E study compared to the period where they did not receive Catena®. There
was no change in the rate of decline in FVC between the off-medication period
and the DELPHI-E study period. Comparing data from DELPHI-E with natural history
data for Duchenne Muscular Dystrophy obtained at the Children's Hospital of
Philadelphia showed that patients in the DELPHI-E study performed better in PEF
for ages 16 and older and in FVC for ages 18 and older. This suggests that
Catena® possibly slows the progression of respiratory dysfunction in these age
periods.
"Despite the limitations from the open-label nature, our preliminary analysis of
the DELPHI-E study indicates that treatment with Catena® can slow the decline in
respiratory function associated with increased age in patients suffering from
Duchenne Muscular Dystrophy. Results from this 2-year intervention study are in
agreement with and confirm data from the 12-month placebo-controlled DELPHI
study," said Thomas Meier, Chief Scientific Officer of Santhera. "Importantly,
these findings add to the validation of the clinical relevance of the
respiratory endpoint we are using in the ongoing DELOS study. This Phase III
study is set up to further evaluate the efficacy of Catena® on respiratory
function in Duchenne Muscular Dystrophy".
In addition to the preliminary analysis of the open label extension of the
DELPHI study, Santhera will present an update on the ongoing DELOS Phase III
study with Catena® in Duchenne Muscular Dystrophy [2].
References
[1] Buyse G.M., Goemans N., van den Hauwe M., Thijs D., Wei Hui, Rummey C.,
Meier T., Mertens L.: Results from a two-year open label intervention study with
idebenone (Catena®) in patients with Duchene Muscular Dystrophy. Poster
presentation at the 4th International Congress of Myology in Lille, France, from
May 9 to 13, 2011.
[2] Buyse G.M., Voit T., Schara U., Verschuuren J., Bernert G., Jeannet P.Y.,
Sejersen T., Rummey C., Rubino R., Meier T. on behalf of the DELOS study
consortium: Update of an Ongoing International Phase III Study with Idebenone
(Catena®) in Patients with Duchenne Muscular Dystrophy - The DELOS Study. Poster
presentation at the 4th International Congress of Myology in Lille, France, from
May 9 to 13, 2011.
About Duchenne Muscular Dystrophy
Duchenne Muscular Dystrophy is the most common and a devastating type of
muscular degeneration and results in rapidly progressive muscle weakness. It is
a genetic, degenerative disease that is inherited in an X-linked recessive mode.
Duchenne Muscular Dystrophy affects approximately 30,000 patients in the USA,
EU, and Japan and its incidence is approximately 1 in 3,500 live born males
worldwide. Duchenne Muscular Dystrophy is characterized by a loss of the protein
dystrophin, leading to progressive muscle weakness and wasting through a complex
cascade that involves impaired calcium homeostasis, mitochondrial dysfunction
and oxidative stress. The average age of onset is between 3 and 5 years of age
with a loss of ambulation in teenage patients. Dilated cardiomyopathy and
respiratory failure are commonly associated with this chronic disease leading to
early morbidity and mortality in Duchenne Muscular Dystrophy patients.
* * *
About Santhera
Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company
focused on the development and commercialization of innovative pharmaceutical
products for the treatment of severe neuromuscular diseases, an area of high
unmet medical need which includes many orphan indications with no current
therapy. Santhera's first product, Catena®, to treat Friedreich's Ataxia is
marketed in Canada. For further information, please visit www.santhera.com.
Catena® is a trademark of Santhera Pharmaceuticals.
For further information, contact
Thomas Meier, Chief Scientific Officer
Phone: +41 (0)61 906 89 52
thomas.meier@santhera.com
Thomas Staffelbach, Head Public & Investor Relations
Phone: +41 (0)61 906 89 47
thomas.staffelbach@santhera.com
Disclaimer/Forward-looking statements
This communication does not constitute an offer or invitation to subscribe for
or purchase any securities of Santhera Pharmaceuticals Holding AG. This
publication may contain certain forward-looking statements concerning the
Company and its business. Such statements involve certain risks, uncertainties
and other factors which could cause the actual results, financial condition,
performance or achievements of the Company to be materially different from those
expressed or implied by such statements. Readers should therefore not place
undue reliance on these statements, particularly not in connection with any
contract or investment decision. The Company disclaims any obligation to update
these forward-looking statements.
--- Ende der Mitteilung ---
Santhera Pharmaceuticals Holding AG
Hammerstrasse 49 Liestal Schweiz
ISIN: CH0027148649;
Myology DELPHI-E:
http://hugin.info/137261/R/1513357/449168.pdf
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Santhera Pharmaceuticals Holding AG via Thomson Reuters ONE
[HUG#1513357]
Santhera Presents Data from 2-Year Open-Label Intervention Study with Catena® in
Duchenne Muscular Dystrophy at the MYOLOGY 2011 Conference
. Verarbeitet und übermittelt durch Thomson Reuters ONE.
Für den Inhalt der Mitteilung ist der Emittent verantwortlich.
Liestal, Switzerland, May 9, 2011 - Santhera Pharmaceuticals (SIX: SANN)
announced today that it will present first analyses of the 2-year open-label
study (DELPHI-E) evaluating Catena® for the treatment of Duchenne Muscular
Dystrophy. The findings indicate that Catena® can slow the decline in
respiratory function associated with patients as they age. Data will be
presented on May 9, 2011 in Lille, France at the 4th International Congress of
Myology [1].
Following a 12-month, randomized, placebo controlled Phase II trial (the DELPHI
study), participants were offered enrollment in a 24-month open-label study
(DELPHI-E). The 19 subjects in the DELPHI-E study received weight-adjusted doses
of Catena® at 450/900 mg/day for body weight of below/above 45 kg. Efficacy was
assessed as change from baseline for respiratory function tests, e.g. peak
expiratory flow (PEF), forced vital capacity (FVC) and maximum inspiratory mouth
pressures (MIP). On average, patients did not receive Catena® for 21 months
between the end of the DELPHI study and their enrollment into the DELPHI-E
study. During this period, a noticeable decline in PEF, FVC and MIP was
observed. Despite the patients' higher age, the rate of decline was numerically
lower for PEF and MIP when patients received Catena® treatment during the
DELPHI-E study compared to the period where they did not receive Catena®. There
was no change in the rate of decline in FVC between the off-medication period
and the DELPHI-E study period. Comparing data from DELPHI-E with natural history
data for Duchenne Muscular Dystrophy obtained at the Children's Hospital of
Philadelphia showed that patients in the DELPHI-E study performed better in PEF
for ages 16 and older and in FVC for ages 18 and older. This suggests that
Catena® possibly slows the progression of respiratory dysfunction in these age
periods.
"Despite the limitations from the open-label nature, our preliminary analysis of
the DELPHI-E study indicates that treatment with Catena® can slow the decline in
respiratory function associated with increased age in patients suffering from
Duchenne Muscular Dystrophy. Results from this 2-year intervention study are in
agreement with and confirm data from the 12-month placebo-controlled DELPHI
study," said Thomas Meier, Chief Scientific Officer of Santhera. "Importantly,
these findings add to the validation of the clinical relevance of the
respiratory endpoint we are using in the ongoing DELOS study. This Phase III
study is set up to further evaluate the efficacy of Catena® on respiratory
function in Duchenne Muscular Dystrophy".
In addition to the preliminary analysis of the open label extension of the
DELPHI study, Santhera will present an update on the ongoing DELOS Phase III
study with Catena® in Duchenne Muscular Dystrophy [2].
References
[1] Buyse G.M., Goemans N., van den Hauwe M., Thijs D., Wei Hui, Rummey C.,
Meier T., Mertens L.: Results from a two-year open label intervention study with
idebenone (Catena®) in patients with Duchene Muscular Dystrophy. Poster
presentation at the 4th International Congress of Myology in Lille, France, from
May 9 to 13, 2011.
[2] Buyse G.M., Voit T., Schara U., Verschuuren J., Bernert G., Jeannet P.Y.,
Sejersen T., Rummey C., Rubino R., Meier T. on behalf of the DELOS study
consortium: Update of an Ongoing International Phase III Study with Idebenone
(Catena®) in Patients with Duchenne Muscular Dystrophy - The DELOS Study. Poster
presentation at the 4th International Congress of Myology in Lille, France, from
May 9 to 13, 2011.
About Duchenne Muscular Dystrophy
Duchenne Muscular Dystrophy is the most common and a devastating type of
muscular degeneration and results in rapidly progressive muscle weakness. It is
a genetic, degenerative disease that is inherited in an X-linked recessive mode.
Duchenne Muscular Dystrophy affects approximately 30,000 patients in the USA,
EU, and Japan and its incidence is approximately 1 in 3,500 live born males
worldwide. Duchenne Muscular Dystrophy is characterized by a loss of the protein
dystrophin, leading to progressive muscle weakness and wasting through a complex
cascade that involves impaired calcium homeostasis, mitochondrial dysfunction
and oxidative stress. The average age of onset is between 3 and 5 years of age
with a loss of ambulation in teenage patients. Dilated cardiomyopathy and
respiratory failure are commonly associated with this chronic disease leading to
early morbidity and mortality in Duchenne Muscular Dystrophy patients.
* * *
About Santhera
Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company
focused on the development and commercialization of innovative pharmaceutical
products for the treatment of severe neuromuscular diseases, an area of high
unmet medical need which includes many orphan indications with no current
therapy. Santhera's first product, Catena®, to treat Friedreich's Ataxia is
marketed in Canada. For further information, please visit www.santhera.com.
Catena® is a trademark of Santhera Pharmaceuticals.
For further information, contact
Thomas Meier, Chief Scientific Officer
Phone: +41 (0)61 906 89 52
thomas.meier@santhera.com
Thomas Staffelbach, Head Public & Investor Relations
Phone: +41 (0)61 906 89 47
thomas.staffelbach@santhera.com
Disclaimer/Forward-looking statements
This communication does not constitute an offer or invitation to subscribe for
or purchase any securities of Santhera Pharmaceuticals Holding AG. This
publication may contain certain forward-looking statements concerning the
Company and its business. Such statements involve certain risks, uncertainties
and other factors which could cause the actual results, financial condition,
performance or achievements of the Company to be materially different from those
expressed or implied by such statements. Readers should therefore not place
undue reliance on these statements, particularly not in connection with any
contract or investment decision. The Company disclaims any obligation to update
these forward-looking statements.
--- Ende der Mitteilung ---
Santhera Pharmaceuticals Holding AG
Hammerstrasse 49 Liestal Schweiz
ISIN: CH0027148649;
Myology DELPHI-E:
http://hugin.info/137261/R/1513357/449168.pdf
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Santhera Pharmaceuticals Holding AG via Thomson Reuters ONE
[HUG#1513357]
Relevante Links: Santhera Pharmaceuticals Holding AG