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News Highlights
September 30th, 2011 - First Patients Enrolled in the PNB01
Phase III clinical development program in Major Depression
PharmaNeuroBoost (PNB), a globally operating CNS Specialty
Biopharmaceutical Company, reported today that it enrolled in
the USA the first patients in its Phase III study with PNB01 in
Major Depressive Disorder (MDD). The primary objective of this
pivotal study is to show a superior rate of Early and Sustained
Responders (ESR) over standard of care citalopram and by this
addressing an unmet medical need in the treatment of MDD, a
devastating disorder.
“This is a major milestone for a Belgian, globally oriented
biopharmaceutical company”, says Chief Executive Officer, Erik
Buntinx, MD, who also is the inventor of PNB01. “PNB’s
experienced management team has been preparing the start of
this phase III program in a ‘record’ short time period”, Buntinx
continues, “and we are proud to have reached this important
milestone as planned after having organized a successful North-
American Investigator’s Meeting in Chicago last week”.
“We feel confident that we will be able to enter the planned
555 patients in this study by next summer and thus expect Top
Line Results to be available by the end of 2012”, says Philippe
Lemmens, PhD and Clinical Study Director, “as we selected over
30 excellent sites with proven experience and in dept expertise
in the field of Major Depression”.
PNB01 is the first of two front-running, late stage proprietary
CNS products of PNB.
August 23, 2011 - PNB ready to enter Phase III development
with PNB01 in Major Depression
Pharmaneuroboost (PNB) reported today that it received
clearance from the Institutional Review Board (IRB) to initiate its
first phase III study with PNB01 in the USA.
“We are particularly excited to have passed this first hurdle on
our way to start phase III with PNB01 in the USA, which is a
rather unique achievement for a small Flemish biotech
company”, says Chief Executive Officer Erik Buntinx, MD. “PNB’s
experienced management team has been preparing this phase
III program for a long time, and we are proud to reach this
important milestone, having met all organizational, regulatory,
financial and also ethical requirements”.
“We expect to obtain similar approvals in Germany and Canada
in the very near future”, says Philippe Lemmens, PhD, Clinical
Study Director. “Previously, competent authorities already
agreed with the clinical trial protocol design, and so we expect
to start recruiting patients in the coming month, pending their
final approval”.
PNB01 is the first of two front-running, late stage proprietary
projects of PNB
February 24rd, 2011 - US and Japanese Composition of
Matter Patent granted for PharmaNeuroBoost’s lead product
PNB01
PharmaNeuroBoost NV (PNB) reported today that both the U.S.
Patent and Trade Office (USPTO) and Japanese Patent Office
(JPT) granted the patent application of its lead product PNB01, a
fixed dose combination of citalopram and low dose
pipamperone, as a pharmaceutical composition of matter, for
treating a mood disorder or an anxiety disorder.
“Having patents already granted in Europe and Canada, PNB01
now enjoys nearly global patent protection”, says the inventor
and CEO Erik Buntinx, psychiatrist, who was first to identify and
report the beneficial clinical effects of PNB01 in patients
suffering from a Major Depressive Disorder (MDD)”.
PNB already reported the promising clinical trial data obtained
with PNB01 over standard of care citalopram from a Phase II
Proof of Concept trial in patients with moderate to severe MDD.
“Reaching this key milestone in addition to having received
supportive regulatory feedback on its planned Phase III
program and the recent closing of EUR 15 M additional funding
from its current investors, enables PNB to start up its late stage
Phase III development program of PNB01”, says Chief
Development Officer Remi Van Den Broeck, MD, MSc “
“When confirmed in Phase III, this novel treatment will be a
breakthrough for physicians and patients who are in need for a
faster and sustained treatment of MDD, a devastating disorder”,
concludes Dr. Erik Buntinx.
PNB01 is the first of two front-running proprietary projects of
PNB.
February 21st, 2011 - Phase III program for PNB01 in Major
Depression to be presented at NCDEU
Pharmaneuroboost (PNB) reported today that the design of it’s
pivotal phase III studies with PNB01 in Major Depressive
Disorder (MDD) will be presented at the 51st NCDEU Conference
held June 13-16 in Boca Raton, Florida.
“The innovative PNB01 phase III program was designed to
optimally demonstrate the unique boosting effects of PNB01
over reference citalopram treatment, and is based on and in line
with global regulatory feedback received”, says Chief Medical
Officer Ludo Haazen, MD.
“We are looking forward to starting this ground-breaking phase
III program in the second half of 2011”, says Remi Van Den
Broeck, MD, Chief Development Officer, “and to confirm the
promising results of our phase II Proof-of-Concept study
reported earlier. “If positive, this novel treatment will be a
breakthrough for physicians and patients who are in need for a
faster and sustained treatment of major depression, a
devastating disorder”, concludes Chief Executive Officer Erik
Buntinx, psychiatrist, who was first to identify and report the
beneficial clinical effects of PNB01 in MDD patients.
PNB01 is the first of two front-running, late stage proprietary
projects of PNB.
June 28, 2010 - Evidence for the selectivity of low dose
pipamperone for 5HT2A
Pharmaneuroboost (PNB) reported today that it will present, on
August 31st, new study results on dose-related 5HT2A receptor
occupancy of pipamperone at the 23th Annual Meeting of the
European College of Neuropsychopharmacology (ECNP) in
Amsterdam. “Our new data confirm that low dose pipamperone
provides adequate 5HT2A binding in humans without clinically
relevant D2 binding at doses that were shown to enhance the
antidepressant effect of citalopram in depressed patients”, says
Chief Executive Officer Erik Buntinx, psychiatrist, who was first
to identify and report the beneficial clinical effects of PNB01 in
patients.
“The data also provide support for a once daily dosing regimen
for PNB01”, continues Erik Buntinx, “and will guide us in
selecting the most appropriate dose(s) of pipamperone to be
tested in further clinical studies to come”.
PNB01 is a proprietary owned, fixed dose combination of
citalopram and low dose pipamperone, and is under
development for the treatment of Major Depressive Disorder.
June 28, 2010 - PharmaNeuroBoost’s lead product in major
depression receives IND approval from FDA.
PharmaNeuroBoost NV (PNB) reported today that the U.S. Food
and Drug Administration (FDA) approved the Investigational
New Drug (IND) application for PNB01. PNB01 is a proprietary
owned, fixed dose combination of citalopram and low dose
pipamperone, and is under development for the treatment of
Major Depressive Disorder. The IND approval permits
PharmaNeuroBoost to initiate a Phase I clinical trial in healthy
volunteers in the US.
Previously, promising results with PNB01 over standard of care
citalopram have been obtained in a UK Phase II Proof of
Concept trial in patients with moderate to severe Major
Depressive Disorder. PNB is currently analyzing the data of its
successful European Phase II study in MDD and planning late
stage development of PNB01.
September 30th, 2011 - First Patients Enrolled in the PNB01
Phase III clinical development program in Major Depression
PharmaNeuroBoost (PNB), a globally operating CNS Specialty
Biopharmaceutical Company, reported today that it enrolled in
the USA the first patients in its Phase III study with PNB01 in
Major Depressive Disorder (MDD). The primary objective of this
pivotal study is to show a superior rate of Early and Sustained
Responders (ESR) over standard of care citalopram and by this
addressing an unmet medical need in the treatment of MDD, a
devastating disorder.
“This is a major milestone for a Belgian, globally oriented
biopharmaceutical company”, says Chief Executive Officer, Erik
Buntinx, MD, who also is the inventor of PNB01. “PNB’s
experienced management team has been preparing the start of
this phase III program in a ‘record’ short time period”, Buntinx
continues, “and we are proud to have reached this important
milestone as planned after having organized a successful North-
American Investigator’s Meeting in Chicago last week”.
“We feel confident that we will be able to enter the planned
555 patients in this study by next summer and thus expect Top
Line Results to be available by the end of 2012”, says Philippe
Lemmens, PhD and Clinical Study Director, “as we selected over
30 excellent sites with proven experience and in dept expertise
in the field of Major Depression”.
PNB01 is the first of two front-running, late stage proprietary
CNS products of PNB.
August 23, 2011 - PNB ready to enter Phase III development
with PNB01 in Major Depression
Pharmaneuroboost (PNB) reported today that it received
clearance from the Institutional Review Board (IRB) to initiate its
first phase III study with PNB01 in the USA.
“We are particularly excited to have passed this first hurdle on
our way to start phase III with PNB01 in the USA, which is a
rather unique achievement for a small Flemish biotech
company”, says Chief Executive Officer Erik Buntinx, MD. “PNB’s
experienced management team has been preparing this phase
III program for a long time, and we are proud to reach this
important milestone, having met all organizational, regulatory,
financial and also ethical requirements”.
“We expect to obtain similar approvals in Germany and Canada
in the very near future”, says Philippe Lemmens, PhD, Clinical
Study Director. “Previously, competent authorities already
agreed with the clinical trial protocol design, and so we expect
to start recruiting patients in the coming month, pending their
final approval”.
PNB01 is the first of two front-running, late stage proprietary
projects of PNB
February 24rd, 2011 - US and Japanese Composition of
Matter Patent granted for PharmaNeuroBoost’s lead product
PNB01
PharmaNeuroBoost NV (PNB) reported today that both the U.S.
Patent and Trade Office (USPTO) and Japanese Patent Office
(JPT) granted the patent application of its lead product PNB01, a
fixed dose combination of citalopram and low dose
pipamperone, as a pharmaceutical composition of matter, for
treating a mood disorder or an anxiety disorder.
“Having patents already granted in Europe and Canada, PNB01
now enjoys nearly global patent protection”, says the inventor
and CEO Erik Buntinx, psychiatrist, who was first to identify and
report the beneficial clinical effects of PNB01 in patients
suffering from a Major Depressive Disorder (MDD)”.
PNB already reported the promising clinical trial data obtained
with PNB01 over standard of care citalopram from a Phase II
Proof of Concept trial in patients with moderate to severe MDD.
“Reaching this key milestone in addition to having received
supportive regulatory feedback on its planned Phase III
program and the recent closing of EUR 15 M additional funding
from its current investors, enables PNB to start up its late stage
Phase III development program of PNB01”, says Chief
Development Officer Remi Van Den Broeck, MD, MSc “
“When confirmed in Phase III, this novel treatment will be a
breakthrough for physicians and patients who are in need for a
faster and sustained treatment of MDD, a devastating disorder”,
concludes Dr. Erik Buntinx.
PNB01 is the first of two front-running proprietary projects of
PNB.
February 21st, 2011 - Phase III program for PNB01 in Major
Depression to be presented at NCDEU
Pharmaneuroboost (PNB) reported today that the design of it’s
pivotal phase III studies with PNB01 in Major Depressive
Disorder (MDD) will be presented at the 51st NCDEU Conference
held June 13-16 in Boca Raton, Florida.
“The innovative PNB01 phase III program was designed to
optimally demonstrate the unique boosting effects of PNB01
over reference citalopram treatment, and is based on and in line
with global regulatory feedback received”, says Chief Medical
Officer Ludo Haazen, MD.
“We are looking forward to starting this ground-breaking phase
III program in the second half of 2011”, says Remi Van Den
Broeck, MD, Chief Development Officer, “and to confirm the
promising results of our phase II Proof-of-Concept study
reported earlier. “If positive, this novel treatment will be a
breakthrough for physicians and patients who are in need for a
faster and sustained treatment of major depression, a
devastating disorder”, concludes Chief Executive Officer Erik
Buntinx, psychiatrist, who was first to identify and report the
beneficial clinical effects of PNB01 in MDD patients.
PNB01 is the first of two front-running, late stage proprietary
projects of PNB.
June 28, 2010 - Evidence for the selectivity of low dose
pipamperone for 5HT2A
Pharmaneuroboost (PNB) reported today that it will present, on
August 31st, new study results on dose-related 5HT2A receptor
occupancy of pipamperone at the 23th Annual Meeting of the
European College of Neuropsychopharmacology (ECNP) in
Amsterdam. “Our new data confirm that low dose pipamperone
provides adequate 5HT2A binding in humans without clinically
relevant D2 binding at doses that were shown to enhance the
antidepressant effect of citalopram in depressed patients”, says
Chief Executive Officer Erik Buntinx, psychiatrist, who was first
to identify and report the beneficial clinical effects of PNB01 in
patients.
“The data also provide support for a once daily dosing regimen
for PNB01”, continues Erik Buntinx, “and will guide us in
selecting the most appropriate dose(s) of pipamperone to be
tested in further clinical studies to come”.
PNB01 is a proprietary owned, fixed dose combination of
citalopram and low dose pipamperone, and is under
development for the treatment of Major Depressive Disorder.
June 28, 2010 - PharmaNeuroBoost’s lead product in major
depression receives IND approval from FDA.
PharmaNeuroBoost NV (PNB) reported today that the U.S. Food
and Drug Administration (FDA) approved the Investigational
New Drug (IND) application for PNB01. PNB01 is a proprietary
owned, fixed dose combination of citalopram and low dose
pipamperone, and is under development for the treatment of
Major Depressive Disorder. The IND approval permits
PharmaNeuroBoost to initiate a Phase I clinical trial in healthy
volunteers in the US.
Previously, promising results with PNB01 over standard of care
citalopram have been obtained in a UK Phase II Proof of
Concept trial in patients with moderate to severe Major
Depressive Disorder. PNB is currently analyzing the data of its
successful European Phase II study in MDD and planning late
stage development of PNB01.
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