Kiadis Pharma N. V.: Kiadis Pharma announces abstracts and presentations for the 60th American Society of Hematology (ASH) An...
07 Novembro 2018 - 04:00AM
Kiadis Pharma
announces abstracts and presentations for the 60th American Society
of Hematology (ASH) Annual Meeting
Amsterdam,
The Netherlands, November 7, 2018 - Kiadis Pharma N.V. ("Kiadis
Pharma" or the "Company") (Euronext Amsterdam and Brussels:
KDS), a clinical-stage biopharmaceutical company, today
announces two data presentations at the 60th American Society of
Hematology (ASH) Annual Meeting. The event will be held December
1-4, 2018, at the San Diego Convention Center in San Diego, CA.
Abstract
120: Efficacy and Safety of a Single Dose of Donor
Lymphocytes Depleted of Alloreactive T-Cells (ATIR101) Following
T-Cell-Depleted Haploidentical HSCT: A Pooled Analysis of Two Phase
II Studies
Type: Oral
Session: 711. Cell Collection
and Processing I
Authors: Denis-Claude Roy et
al.
Date & Presentation time:
Saturday, December 1, 2018, 10:45 AM
Location: Grand Hall A (Manchester
Grand Hyatt San Diego)
Background: An ex vivo photodepletion method has
been developed to produce ATIR101 (Kiadis
Pharma), a donor lymphocyte infusion (2.0 million cells/kg)
administered after haploidentical allogeneic hematopoietic stem
cell transplantation (haplo-HSCT) to aid immune reconstitution.
ATIR101 is depleted of alloreactive T-cells and early
administration after T-cell-depleted haplo-HSCT has the potential
to reduce serious complications resulting from delayed immune
reconstitution, such as infections, malignant relapse, and severe
graft-versus-host disease (GVHD) in the recipient. The safety and
efficacy of a single dose of ATIR101 are presented here in a pooled
analysis of two phase II clinical trials: CR-AIR-007 (NCT01794299)
& CR-AIR-008 (NCT02500550).
Abstract
3474: Depletion of Alloreactive T Cells after
Haploidentical HSCT: Comparison of Outcomes for Ex Vivo Versus In Vivo
Treatment Strategies
Type: Poster
Session: 732. Clinical
Allogeneic Transplantation
Authors: Steven Devine et
al.
Date & Presentation time:
Sunday, December 2, 2018, 6:00 PM-8:00 PM
Location: Hall GH (San Diego
Convention Center)
Background: The use of haploidentical allogeneic
hematopoietic stem cell transplantation (haplo-HSCT) has increased
owing to therapeutic advances that have mitigated the main barriers
such as high incidence of graft-versus-host disease (GVHD) and
non-relapse mortality (NRM). Such T-cell depletion can be
performed in vivo early after
T-cell-replete haplo-HSCT using post-transplant cyclophosphamide
(PTCy). Alternatively, T-cell-depleted haplo-HSCT can be
supplemented with T-lymphocytes that are depleted ex vivo of their alloreactive component in the
form of ATIR101 (Kiadis Pharma). Although
ATIR101 requires cell manufacturing and is more expensive, it
limits toxicity to the patient, enables haplo-HSCT without the use
of immunosuppressants, and may reduce relapse rates. Both
strategies are promising, but no attempt has yet been made to
compare clinical results in similar patient populations to
delineate key features of alloreactive T-cell depletion performed
either ex vivo or in vivo.
For more information, please
contact:
Kiadis Pharma:
Karl Hård, Head of Investor Relations &
Communications
Tel. +31 611 096 298
k.hard@kiadis.com |
Optimum Strategic
Communications:
Mary Clark, Supriya Mathur, Hollie Vile
Tel: +44 203 950 9144
David Brilleslijper (Amsterdam)
Tel: +31 610 942 514
kiadis@optimumcomms.com
|
About Kiadis
Pharma
Kiadis Pharma is developing its lead product candidate, ATIR101,
for use in conjunction with haploidentical (genetically
half-matched) hematopoietic stem-cell transplantations (HSCT) for
adult blood cancers to address key limitations of haploidentical
HSCT, without prophylactic immunosuppression and its associated
morbidity and mortality. Based on the positive results from the
single dose Phase 2 CR-AIR-007 study, the Company submitted a
marketing authorization application to the European Medicines
Agency in April 2017 for approval of ATIR101 as an adjunctive
treatment in haploidentical HSCT for high risk adult hematological
malignancies. If the product is conditionally approved, Kiadis
Pharma intends to launch ATIR101 through its own commercial
organization in a first EU member state in the second half of
2019.
In December 2017, Kiadis Pharma
commenced an international, multicenter, randomized and controlled
Phase 3 clinical trial of ATIR101 against the Post-Transplant
Cyclophosphamide, (PTCy) protocol, the main protocol used to
perform a haploidentical HSCT. The trial will be performed in 250
patients with acute leukemia and myelodysplastic syndrome at
approximately 50 sites in the United States, Canada, Europe and
certain additional countries. ATIR101 received regenerative
medicine advanced therapy (RMAT) designation from the FDA in
September 2017, which provides benefits that are materially
equivalent to a Breakthrough Therapy designation from the FDA. In
addition, ATIR101 has been granted multiple orphan drug
designations both in the European Union and the United States.
The Company's shares are listed on
Euronext Amsterdam and Brussels under the ticker KDS.
Forward Looking
Statements
Certain statements, beliefs and opinions in this
press release are forward-looking, which reflect Kiadis Pharma's
or, as appropriate, Kiadis Pharma's 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, regulation, 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,
Kiadis Pharma 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 Kiadis
Pharma 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.
This
announcement is distributed by West Corporation on behalf of West
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The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Kiadis Pharma N. V. via Globenewswire