INNATE PHARMA : DSMB RECOMMENDS CONTINUATION OF EFFIKIR TRIAL WITH TWO ARMS
26 Mars 2015 - 7:35AM
Innate Pharma SA (the "Company" - Euronext Paris: FR0010331421 -
IPH), the innate immunity company developing first-in-class
therapeutic antibodies for cancer and inflammatory diseases, today
announces that the Data and Safety Monitoring Board ("DSMB")
completed its fourth assessment of the EffiKIR study and
recommended to stop treatment in one arm and continue the trial
with the remaining two arms as per protocol.
In issuing this recommendation, the DSMB
considers that treatment in the stopped arm cannot be superior to
placebo. There is no concern with safety. Patients in the stopped
arm will be followed up as planned. The trial remains blinded. The
Company now expects that analysis on the primary efficacy endpoint,
leukemia-free survival, will occur in Q2 2016.
As specified in the study protocol, the DMSB
meets every six months to examine the safety data accumulated
during progress of the trial.
About EffiKIR (study IPH2102-201):
EffiKIR is a double-blind placebo-controlled
randomized Phase II trial of lirilumab as maintenance treatment in
elderly patients with Acute Myeloid Leukemia ("AML") in first
complete remission. The protocol initially called for inclusion of
150 patients, randomized into three arms. Two arms test single
agent lirilumab at different doses and treatment intervals and in
the third arm, patients receive placebo. The primary efficacy
endpoint is leukemia-free survival. Secondary endpoints include
safety and overall survival. In March 2015, the treatment was
discontinued in one treatment arm in accordance with the DMSB's
recommendation. The trial continues with the two remaining arms, as
per protocol.
The rationale of this trial is based on the
capacity of activated Natural Killer (NK) cells to directly kill
tumor cells and trigger broad immune activation. This rationale is
supported by clinical studies showing that activated NK cells can
significantly lower the recurrence of various hematological
malignancies, including AML, following hematopoietic stem cell
transplantation 1.
This trial is sponsored by Innate Pharma and is
performed in France, with the participation of the two French
clinical cooperative groups, ALFA and GOELAMS 2, harnessing
the research effort of the French centers qualified to treat
patients with AML.
About lirilumab (IPH2102/BMS-986015):
Lirilumab is a fully human monoclonal antibody
(mAb) that blocks the interaction between Killer-cell
immunoglobulin-like receptors (KIR) on NK cells and their ligands.
Blocking these receptors facilitates activation of NK cells and
destruction of tumor cells.
Lirilumab is licensed to Bristol-Myers Squibb
Company. As part of the agreement between Innate Pharma and
Bristol-Myers Squibb, Bristol-Myers Squibb holds exclusive
worldwide rights to develop, manufacture and commercialize
lirilumab and related compounds blocking KIR receptors, for all
indications. Under the agreement, Innate Pharma conducts the
development of lirilumab through Phase II in AML.
In addition to the EffiKIR trial, where
lirilumab is currently being tested in a randomized, double-blind,
placebo-controlled Phase II trial in elderly patients as a
single-agent in AML, lirilumab is also being evaluated by
Bristol-Myers Squibb in clinical trials in combination with other
immuno-oncology agents in a variety of tumor types.
About Innate Pharma:
Innate Pharma S.A. is a biopharmaceutical
company discovering and developing first-in-class therapeutic
antibodies for the treatment of cancer and inflammatory
diseases.
Its innovative approach has translated into
major alliances with leaders in the biopharmaceutical industry such
as Bristol-Myers Squibb and Novo Nordisk A/S.
The Company has two clinical-stage programs in
immuno-oncology, a new therapeutic field that is changing cancer
treatment by enhancing the capability of the body's own immune
cells to recognize and kill cancer cells. Innate Pharma's science
also has potential in chronic inflammatory diseases.
Listed on Euronext-Paris, Innate Pharma is based
in Marseille, France, and had 99 employees as at December 31,
2014.
Learn more about Innate Pharma at
www.innate-pharma.com.
Practical Information about Innate Pharma
shares:
ISIN
code Ticker code |
FR0010331421 IPH |
Disclaimer: This press release contains
certain forward-looking statements. Although the company believes
its expectations are based on reasonable assumptions, these
forward-looking statements are subject to numerous risks and
uncertainties, which could cause actual results to differ
materially from those anticipated. For a discussion of risks and
uncertainties which could cause the company's actual results,
financial condition, performance or achievements to differ from
those contained in the forward-looking statements, please refer to
the Risk Factors ("Facteurs de Risque") section of the Document de
Reference prospectus filed with the AMF, which is available on the
AMF website (http://www.amf-france.org) or on Innate Pharma's
website.
This press release and the information contained
herein do not constitute an offer to sell or a solicitation of an
offer to buy or subscribe to shares in Innate Pharma in any
country.
For additional information, please
contact:
Innate Pharma |
ATCG
Press |
Laure-Hélène Mercier Director,
Investor Relations |
Judith
Aziza, Mob.:+33 (0)6 70 07 77 51 Marielle Bricman, Mob.:+33 (0)6 26
94 18 53 |
Tel.: +33 (0)4 30 30 30 87 |
|
investors@innate-pharma.com |
presse@atcg-partners.com |
1- Ruggeri et al, Blood, 2007, Giebel et al.,
Blood, 2003, Velardi et al, Science, 2002
2- ALFA : Acute Leukemia French
Association. GOELAMS : Groupe Ouest-Est des Leucémies Aiguës
et Maladies du Sang (Acute Leukemia and Blood Diseases
West-Est Group)
DSMB RECOMMENDS CONTINUATION OF EFFIKIR TRIAL WITH TWO ARMS
http://hugin.info/155662/R/1906318/678643.pdf
HUG#1906318
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