Dec 21, 2019
Le comité de sécurité de surveillance des données confirme la sécurité et
valide le recrutement des prochains patients
NOXXON Pharma N.V. (Euronext Growth Paris : ALNOX), société de biotechnologie développant principalement des traitements contre le cancer en ciblant le microenvironnement tumoral (MET), annonce aujourd'hui qu'un examen prévu par le comité de sécurité de surveillance des données (Data Safety Monitoring Board - DSMB) a analysé les données de sécurité provenant des dix premières semaines de traitement du patient recruté dans
l’essai clinique de NOX-A12 en association avec la radiothérapie dans le cancer du cerveau. Sur la
base de cette évaluation, le comité de sécurité a confirmé qu'il est approprié de poursuivre le
recrutement de patients supplémentaires conformément au protocole de l'étude.
Les centres d'essais cliniques participant à l'étude ont donc initié le recrutement des patients restants
de cette cohorte traitée à la première des trois doses croissantes dans le cadre de l’étude. Une fois que
les patients de cette cohorte auront chacun reçu le traitement de NOX-A12 en association avec la
radiothérapie pendant quatre semaines, le comité de sécurité se réunira de nouveau pour déterminer
s'il est prudent de passer à la seconde dose de NOX-A12.
« Nous sommes encouragés par cette première confirmation du profil de sécurité du NOX-A12 », a
déclaré Aram Mangasarian, Président Directeur Général de NOXXON. « Suite à cette analyse,
l'essai peut continuer comme prévu afin que les prochains patients puissent être traités dans le cadre
du protocole. Nous restons concentrés sur l'atteinte de notre objectif d'obtenir des données de la
première cohorte de patients en milieu d’année 2020, et des deuxième et troisième cohortes
respectivement au quatrième trimestre 2020 et au deuxième trimestre 2021. »
À propos de NOXXON
Les produits oncologiques développés par NOXXON agissent sur le microenvironnement tumoral et le
cycle immunitaire anticancéreux par la rupture de la barrière de protection tumorale et l’inhibition de la
réparation tumorale. En neutralisant des chimiokines dans le microenvironnement tumoral, NOXXON
associe son approche à celle d’autres types de traitement afin d’affaiblir les défenses tumorales contre
le système immunitaire et d’augmenter l’impact thérapeutique. Son programme phare, le NOX-A12,
s’appuie sur un long développement clinique et de nombreuses données de sécurité. Les premiers
résultats de l’essai clinique de phase I/II sur l’association de NOX-A12 avec le Keytruda®, chez des
patients atteints d’un cancer métastatique colorectal ou du pancréas, ont été publiés en décembre 2018
et de prochaines études dans ces indications sont en cours de planification. En septembre 2019, la
société a initié une autre étude avec le NOX-A12 dans le cancer du cerveau en association avec la
radiothérapie, qui a obtenu le statut de médicament orphelin aux États-Unis et en Europe pour le
traitement de certains cancers du cerveau. Le deuxième actif de la société en développement clinique,
le NOX-E36, agit sur le microenvironnement tumoral en ciblant le système immunitaire inné.
NOXXON
prévoit d’évaluer l’action de NOX-E36 chez les patients atteints d’un cancer du pancréas, en
monothérapie ainsi qu’en association. Plus d’informations sont disponibles sur : www.noxxon.com.
Keytruda® est une marque déposée de Merck Sharp & Dohme Corp.
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