BioSenic performs further analysis of its phase 2 clinical trial
data, leading to an optimal administration scheme for its next
late-stage trial of arsenic trioxide in cGvHD
BioSenic
performs further analysis of its
phase 2 clinical
trial data, leading to
an optimal administration
scheme for its next late-stage trial of arsenic
trioxide in cGvHD
New post-hoc analysis suggests
a repeated
administration cycle for
BioSenic's upcoming
phase 3 trial of oral
arsenic trioxide
(ATO) in
chronic graft-versus-host disease
(cGvHD)
Mont-Saint-Guibert, Belgium,
September
27,
2023,
7.00am
CEST –
BIOSENIC (Euronext Brussels and Paris: BIOS), the
clinical-stage company specializing in serious autoimmune and
inflammatory diseases and cell therapy, today announces the
completion of a post-hoc analysis of its phase 2 clinical trial of
ATO, finding the best scheme for administration of an efficient
treatment of cGvHD. The analysis will be used to decide on the best
oral ATO’s posology for BioSenic’s forthcoming phase 3 clinical
trial.
BioSenic phase 2 clinical trial entitled
‘Treatment of Chronic Graft Versus Host Disease with Arsenic
Trioxide (GvHD-ATO)’ was conducted from 2016 to 2020
(ClinicalTrials.gov ID NCT02966301 - GMED16-001). The first results
were originally published in 2022 in the peer-reviewed journal
Transplantation and Cellular Therapy under the title ‘High Response
Rate and Corticosteroid (CS) Sparing with Arsenic Trioxide-Based
First-Line Therapy in Chronic Graft-versus-Host Disease after
Allogeneic Hematopoietic Stem Cell Transplantation’. These collated
results demonstrated that the first-line use of ATO and
corticosteroids is associated with a high clinical response rate
and rapid CS sparing in moderate to severe cGvHD following
allo-HSCT (current standard treatment for several types of
leukaemias). The primary endpoint of the phase 2 trial was
preliminary efficacy based on the overall response rate (ORR;
complete response [CR] or partial response [PR]) at 6 months, after
1 or 2 cycles of intravenous (IV) ATO treatment. At 6 months, the
ORR was 75.0%, with a CR rate of 35% and PR of 40%.
BioSenic’s new post-hoc analysis of the full set
of clinical data gained during the phase 2 trial shows that among
the group of patients who did not achieved complete remission after
the first course, a significant one-fifth of these patients had a
positive primary endpoint following a second cycle of treatment. As
a result, BioSenic will further use this 2-cycle treatment in its
forthcoming trials. This will involve the administration of a
double four-week course, separated by a rest period, resulting in a
two-to-four times higher total dose of ATO. BioSenic expects thus
to get closer to the optimal conditions for a curative treatment
for cGvHD, for which there is currently no satisfactory
therapy.
In the field of oncology, IV ATO is used as a
first-line treatment for acute promyelocytic leukemia (APL) since
2003, with demonstrated safety and long-term remissions. Until now,
in APL, ATO was administered daily by IV infusions for up to, or
more than, a hundred accumulated doses. IV administration, because
it requires hospitalization, is not practical for patients, results
in lower quality of life, and is very expensive. The introduction
of an oral formulation of ATO during 2 short cycles, presently
BioSenic’s optimal design of administration, will greatly improve
patient quality of life and compliance, while reducing healthcare
costs. This is a significant achievement in BioSenic’s aim to
contribute improved and potentially curative treatment for an
autoimmune disease, with no current satisfactory medical
solutions.
François Rieger, PhD, Chairman and CEO,
BioSenic said: "BioSenic is continuing to investigate new
tricks that an old medication accomplishes in the field of
autoimmune diseases. BioSenic’s preclinical and clinical data show
that the first-in-class modulatory properties for immune
differentiation and homeostatic maintenance of the immune system of
arsenic trioxide is much wider and profound than anticipated. The
systematic analysis of BioSenic’s clinical results is delivering
additional conclusions on the mechanism of action of arsenic salts
and also on the optimization of its formulations, dosages and
optimal treatment timing. We are now focused on the finalizing
preparations for our phase 3 trial of a new oral formulation of ATO
targeting chronic graft-versus-host disease and devoting our
efforts to exploiting clinical data reflecting the properties of
arsenic trioxide to provide curative treatments for patients with
autoimmune diseases for whom palliative medical treatments are
unsatisfactory.”
About BioSenic
BioSenic is a leading biotech company
specializing in the development of clinical assets issued from: (i)
the arsenic trioxide (ATO) platform (with key target indications
including Graft-versus-Host Disease (GvHD), systemic lupus
erythematosus (SLE) and systemic sclerosis (SSc) and (ii), the
development of innovative products to meet unmet needs in
orthopedics.Following a reverse merger in October 2022, BioSenic
combined a strategic positionings and strengths to use, separately
and combined, an entirely new arsenal of various anti-inflammatory
and anti-autoimmune formulations using the immunomodulatory
properties of ATO/oral ATO (OATO) with its innovative cell therapy
platform and strong IP for tissue repair protection.BioSenic is
based in the Louvain-la-Neuve Science Park in Mont-Saint-Guibert,
Belgium. Further information is available at
http://www.biosenic.com.
About BioSenic technology
platforms
BioSenic’s technology is based on two main
platforms:1) The ATO platform, which has been
successfully developed, has immunomodulatory properties with
fundamental effects on the activated cells of the immune system.
The first effect is the increase of the cell oxidative stress in
activated B, T and other cells of the innate/adaptative immune
system to the point they will enter a cell death program
(apoptosis) and be eliminated. The second effect is potent
immunomodulatory properties on several cytokines involved in
inflammatory or autoimmune cell pathways, with return to
homeostasis. One direct application is its use in onco-immunology
to treat GvHD (Graft-versus-Host Disease) in its chronic,
established stage. cGvHD is one of the most common and clinically
significant complications affecting long-term survival of
allogeneic hematopoietic stem cell transplantation (allo-HSCT).
cGvHD is primarily mediated by the transplanted immune cells that
can lead to severe multiorgan damage. BioSenic has been successful
in a Phase 2 trial with its intravenous formulation, which has
orphan drug designation status by FDA and EMA. The Company is
heading towards an international Phase 3 confirmatory study, with
its new, IP-protected, OATO formulation. Another selected target is
moderate-to-severe forms of systemic lupus erythematosus (SLE),
using the same oral formulation. ATO has shown good safety and
significant clinical efficacy on several affected organs (skin,
mucosae and the gastrointestinal tract) in an early Phase 2a study.
Systemic sclerosis is also part of the clinical pipeline of
BioSenic. This serious chronic disease badly affects skin, lungs or
vascularization, and has no actual current effective treatment.
Preclinical studies on pertinent animal models are positive, giving
good grounds to launch a Phase 2 clinical protocol.
2) The allogeneic cell and gene therapy platform
developed by BioSenic, with differentiated bone marrow sourced
Mesenchymal Stromal Cells (MSCs), which can be stored at the point
of use in hospitals. ALLOB represents a unique and proprietary
approach to organ repair and specifically to bone regeneration, by
turning undifferentiated stromal cells from healthy donors into
bone-forming cells on the site of injury. ALLOB has recently been
evaluated in a randomized, double-blind, placebo-controlled Phase
2b study in patients with high-risk tibial fractures, using its
optimized production process, after a successful first safety and
efficacy study (Phase 1/2a) on fractured long bones, with
late-delayed union. However, in June 2023, BioSenic decided to
suspend its interventional trial on fracture healing using ALLOB,
following negative results obtained for the primary endpoint in
this exploratory Phase 2b clinical trial, interpreted as a failure
of a too early cell injection, just after fracture. BioSenic is now
focusing on determining the best time to optimise the efficacy of
ALLOB (choice between early or late treatment).Note: Biosenic has
reevaluated a previous important and years-long clinical
development program. In March 2023, after the clinical
identification of distinct OA subtypes, BioSenic delivered a new
post-hoc analysis of its Phase 3 JTA-004 trial on knee OA,
demonstrating positive action on the most severely affected patient
subpopulation. This new post-hoc analysis drastically changes the
therapeutic profile of the combined components and allows for
better patient targeting in future clinical developments. This
leads to a next generation of JTA, off-the-shelf enhanced
viscosupplement to treat knee osteoarthritis (OA), made of a unique
combination of mammalian plasma proteins, derivatives of hyaluronic
acid (a natural component of synovial fluid in the knee) and a
third active component. JTA or some derivatives are intended to
provide effective lubrication and protection to the cartilage of
the arthritic joint and to alleviate osteoarthritic (OA) pain and
inflammation. The company, will nevertheless focus its present
R&D and clinical activities on a selective, accelerated
development of its autoimmune (ATO/OATO) platform.
For further information, please
contact:
BioSenic SAFrançois Rieger, PhD,
Chief Executive OfficerTel: +33 (0)671 73 31
59investorrelations@biosenic.com
International Media Enquiries:IB
CommunicationsNeil Hunter / Michelle BoxallTel: +44 (0)20
8943 4685neil.hunter@ibcomms.agency / michelle@ibcomms.agency
For French Investor
Enquiries:Seitosei
ActifinGhislaine GasparettoTel: +33 (0)1 56 88 11
22ggasparetto@actifin.fr
Certain statements, beliefs and opinions in this
press release are forward-looking, which reflect the Company or, as
appropriate, the Company directors’ current expectations and
projections about future events. By their nature, forward-looking
statements involve a number of risks, uncertainties and assumptions
that could cause actual results or events to differ materially from
those expressed or implied by the forward-looking statements. These
risks, uncertainties and assumptions could adversely affect the
outcome and financial effects of the plans and events described
herein. A multitude of factors including, but not limited to,
changes in demand, competition and technology, can cause actual
events, performance or results to differ significantly from any
anticipated development. Forward looking statements contained in
this press release regarding past trends or activities should not
be taken as a representation that such trends or activities will
continue in the future. As a result, the Company expressly
disclaims any obligation or undertaking to release any update or
revisions to any forward-looking statements in this press release
as a result of any change in expectations or any change in events,
conditions, assumptions or circumstances on which these
forward-looking statements are based. Neither the Company nor its
advisers or representatives nor any of its subsidiary undertakings
or any such person’s officers or employees guarantees that the
assumptions underlying such forward-looking statements are free
from errors nor does either accept any responsibility for the
future accuracy of the forward-looking statements contained in this
press release or the actual occurrence of the forecasted
developments. You should not place undue reliance on
forward-looking statements, which speak only as of the date of this
press release.
INSIDE INFORMATIONS
New post-hoc analysis suggests a repeated
administration cycle for BioSenic's upcoming phase 3 trial of oral
arsenic trioxide (ATO) in chronic graft-versus-host disease
(cGvHD)
Mont-Saint-Guibert, Belgium, September
27, 2023, 7.00am CEST – BIOSENIC (Euronext Brussels and
Paris: BIOS), the clinical-stage company specializing in serious
autoimmune and inflammatory diseases and cell therapy, today
announces the completion of a post-hoc analysis of its phase 2
clinical trial of ATO, finding the best scheme for administration
of an efficient treatment of cGvHD. The analysis will be used to
decide on the best oral ATO’s posology for BioSenic’s forthcoming
phase 3 clinical trial.
BioSenic phase 2 clinical trial entitled
‘Treatment of Chronic Graft Versus Host Disease with Arsenic
Trioxide (GvHD-ATO)’ was conducted from 2016 to 2020
(ClinicalTrials.gov ID NCT02966301 - GMED16-001). The first results
were originally published in 2022 in the peer-reviewed journal
Transplantation and Cellular Therapy under the title ‘High Response
Rate and Corticosteroid (CS) Sparing with Arsenic Trioxide-Based
First-Line Therapy in Chronic Graft-versus-Host Disease after
Allogeneic Hematopoietic Stem Cell Transplantation’. These collated
results demonstrated that the first-line use of ATO and
corticosteroids is associated with a high clinical response rate
and rapid CS sparing in moderate to severe cGvHD following
allo-HSCT (current standard treatment for several types of
leukaemias). The primary endpoint of the phase 2 trial was
preliminary efficacy based on the overall response rate (ORR;
complete response [CR] or partial response [PR]) at 6 months, after
1 or 2 cycles of intravenous (IV) ATO treatment. At 6 months, the
ORR was 75.0%, with a CR rate of 35% and PR of 40%.
BioSenic’s new post-hoc analysis of the full set
of clinical data gained during the phase 2 trial shows that among
the group of patients who did not achieved complete remission after
the first course, a significant one-fifth of these patients had a
positive primary endpoint following a second cycle of treatment. As
a result, BioSenic will further use this 2-cycle treatment in its
forthcoming trials. This will involve the administration of a
double four-week course, separated by a rest period, resulting in a
two-to-four times higher total dose of ATO. BioSenic expects thus
to get closer to the optimal conditions for a curative treatment
for cGvHD, for which there is currently no satisfactory
therapy.
In the field of oncology, IV ATO is used as a
first-line treatment for acute promyelocytic leukemia (APL) since
2003, with demonstrated safety and long-term remissions. Until now,
in APL, ATO was administered daily by IV infusions for up to, or
more than, a hundred accumulated doses. IV administration, because
it requires hospitalization, is not practical for patients, results
in lower quality of life, and is very expensive. The introduction
of an oral formulation of ATO during 2 short cycles, presently
BioSenic’s optimal design of administration, will greatly improve
patient quality of life and compliance, while reducing healthcare
costs. This is a significant achievement in BioSenic’s aim to
contribute improved and potentially curative treatment for an
autoimmune disease, with no current satisfactory medical
solutions.
François Rieger, PhD, Chairman and CEO,
BioSenic said: "BioSenic is continuing to investigate new
tricks that an old medication accomplishes in the field of
autoimmune diseases. BioSenic’s preclinical and clinical data show
that the first-in-class modulatory properties for immune
differentiation and homeostatic maintenance of the immune system of
arsenic trioxide is much wider and profound than anticipated. The
systematic analysis of BioSenic’s clinical results is delivering
additional conclusions on the mechanism of action of arsenic salts
and also on the optimization of its formulations, dosages and
optimal treatment timing. We are now focused on the finalizing
preparations for our phase 3 trial of a new oral formulation of ATO
targeting chronic graft-versus-host disease and devoting our
efforts to exploiting clinical data reflecting the properties of
arsenic trioxide to provide curative treatments for patients with
autoimmune diseases for whom palliative medical treatments are
unsatisfactory.”
About BioSenic
BioSenic is a leading biotech company
specializing in the development of clinical assets issued from: (i)
the arsenic trioxide (ATO) platform (with key target indications
including Graft-versus-Host Disease (GvHD), systemic lupus
erythematosus (SLE) and systemic sclerosis (SSc) and (ii), the
development of innovative products to meet unmet needs in
orthopedics.Following a reverse merger in October 2022, BioSenic
combined a strategic positionings and strengths to use, separately
and combined, an entirely new arsenal of various anti-inflammatory
and anti-autoimmune formulations using the immunomodulatory
properties of ATO/oral ATO (OATO) with its innovative cell therapy
platform and strong IP for tissue repair protection.BioSenic is
based in the Louvain-la-Neuve Science Park in Mont-Saint-Guibert,
Belgium. Further information is available at
http://www.biosenic.com.
About BioSenic technology
platforms
BioSenic’s technology is based on two main
platforms:
- The ATO platform, which has been successfully developed, has
immunomodulatory properties with fundamental effects on the
activated cells of the immune system. The first effect is the
increase of the cell oxidative stress in activated B, T and other
cells of the innate/adaptative immune system to the point they will
enter a cell death program (apoptosis) and be eliminated. The
second effect is potent immunomodulatory properties on several
cytokines involved in inflammatory or autoimmune cell pathways,
with return to homeostasis. One direct application is its use in
onco-immunology to treat GvHD (Graft-versus-Host Disease) in its
chronic, established stage. cGvHD is one of the most common and
clinically significant complications affecting long-term survival
of allogeneic hematopoietic stem cell transplantation (allo-HSCT).
cGvHD is primarily mediated by the transplanted immune cells that
can lead to severe multiorgan damage. BioSenic has been successful
in a Phase 2 trial with its intravenous formulation, which has
orphan drug designation status by FDA and EMA. The Company is
heading towards an international Phase 3 confirmatory study, with
its new, IP-protected, OATO formulation. Another selected target is
moderate-to-severe forms of systemic lupus erythematosus (SLE),
using the same oral formulation. ATO has shown good safety and
significant clinical efficacy on several affected organs (skin,
mucosae and the gastrointestinal tract) in an early Phase 2a study.
Systemic sclerosis is also part of the clinical pipeline of
BioSenic. This serious chronic disease badly affects skin, lungs or
vascularization, and has no actual current effective treatment.
Preclinical studies on pertinent animal models are positive, giving
good grounds to launch a Phase 2 clinical protocol.
- The allogeneic cell and gene therapy platform developed by
BioSenic, with differentiated bone marrow sourced Mesenchymal
Stromal Cells (MSCs), which can be stored at the point of use in
hospitals. ALLOB represents a unique and proprietary approach to
organ repair and specifically to bone regeneration, by turning
undifferentiated stromal cells from healthy donors into
bone-forming cells on the site of injury. ALLOB has recently been
evaluated in a randomized, double-blind, placebo-controlled Phase
2b study in patients with high-risk tibial fractures, using its
optimized production process, after a successful first safety and
efficacy study (Phase 1/2a) on fractured long bones, with
late-delayed union. However, in June 2023, BioSenic decided to
suspend its interventional trial on fracture healing using ALLOB,
following negative results obtained for the primary endpoint in
this exploratory Phase 2b clinical trial, interpreted as a failure
of a too early cell injection, just after fracture. BioSenic is now
focusing on determining the best time to optimise the efficacy of
ALLOB (choice between early or late treatment).
Note: Biosenic has reevaluated a previous
important and years-long clinical development program. In March
2023, after the clinical identification of distinct OA subtypes,
BioSenic delivered a new post-hoc analysis of its Phase 3 JTA-004
trial on knee OA, demonstrating positive action on the most
severely affected patient subpopulation. This new post-hoc analysis
drastically changes the therapeutic profile of the combined
components and allows for better patient targeting in future
clinical developments. This leads to a next generation of JTA,
off-the-shelf enhanced viscosupplement to treat knee osteoarthritis
(OA), made of a unique combination of mammalian plasma proteins,
derivatives of hyaluronic acid (a natural component of synovial
fluid in the knee) and a third active component. JTA or some
derivatives are intended to provide effective lubrication and
protection to the cartilage of the arthritic joint and to alleviate
osteoarthritic (OA) pain and inflammation. The company, will
nevertheless focus its present R&D and clinical activities on a
selective, accelerated development of its autoimmune (ATO/OATO)
platform.
For further information, please
contact:
BioSenic SAFrançois Rieger, PhD,
Chief Executive OfficerTel: +33 (0)671 73 31
59investorrelations@biosenic.com
International Media Enquiries:IB
CommunicationsNeil Hunter / Michelle BoxallTel: +44 (0)20
8943 4685neil.hunter@ibcomms.agency / michelle@ibcomms.agency
For French Investor Enquiries:Seitosei
ActifinGhislaine GasparettoTel: +33 (0)1 56 88 11
22ggasparetto@actifin.fr
Certain statements,
beliefs and opinions in this press release are forward-looking,
which reflect the Company or, as appropriate, the Company
directors’ current expectations and projections about future
events. By their nature, forward-looking statements involve a
number of risks, uncertainties and assumptions that could cause
actual results or events to differ materially from those expressed
or implied by the forward-looking statements. These risks,
uncertainties and assumptions could adversely affect the outcome
and financial effects of the plans and events described herein. A
multitude of factors including, but not limited to, changes in
demand, competition and technology, can cause actual events,
performance or results to differ significantly from any anticipated
development. Forward looking statements contained in this press
release regarding past trends or activities should not be taken as
a representation that such trends or activities will continue in
the future. As a result, the Company expressly disclaims any
obligation or undertaking to release any update or revisions to any
forward-looking statements in this press release as a result of any
change in expectations or any change in events, conditions,
assumptions or circumstances on which these forward-looking
statements are based. Neither the Company nor its advisers or
representatives nor any of its subsidiary undertakings or any such
person’s officers or employees guarantees that the assumptions
underlying such forward-looking statements are free from errors nor
does either accept any responsibility for the future accuracy of
the forward-looking statements contained in this press release or
the actual occurrence of the forecasted developments. You should
not place undue reliance on forward-looking statements, which speak
only as of the date of this press release.
Biosenic (EU:BIOS)
과거 데이터 주식 차트
부터 5월(5) 2024 으로 6월(6) 2024
Biosenic (EU:BIOS)
과거 데이터 주식 차트
부터 6월(6) 2023 으로 6월(6) 2024