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PharmaMar termine le recrutement des patientes pour l'étude pivot de phase III « CORAIL » sur le PM1183
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News provided by

PharmaMar

Oct 18, 2016, 03:00 ET

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MADRID, October 18, 2016 /PRNewswire/ --

PharmaMar (MCE : PHM) annonce aujourd'hui l'achèvement couronné de succès du recrutement des patientes pour l'étude pivot et randomisée de phase III « CORAIL » sur la lurbinectédine (PM1183), portant sur le traitement du cancer de l'ovaire résistant au platine. 443 patientes provenant de plus de 100 hôpitaux en Europe et aux États-Unis ont été inclus dans l'étude.  

Pharma Mar SA (PRNewsFoto/Pharma Mar SA)
Pharma Mar SA (PRNewsFoto/Pharma Mar SA)

     (Logo: http://photos.prnewswire.com/prnh/20150203/727958-b )

L'étude « CORAIL » évalue l'efficacité du PM1183 en comparaison avec le topotécan ou la doxorubicine liposomale pégylée, standard de soin pour cette pathologie. Comme l'explique le Dr Arturo Soto, directeur du service clinique de l'unité opérationnelle d'oncologie de PharmaMar : « L'étude a été achevée avec trois mois d'avance sur le programme, ce qui traduit l'intérêt porté au médicament et à l'étude, ainsi que le besoin exprimé par les enquêteurs pour une nouvelle alternative thérapeutique pour ces patientes. »

À propos de la lurbinectédine (PM1183)  

Le PM1183 est un composé qui fait actuellement l'objet de recherches cliniques. C'est un inhibiteur de l'enzyme ARN polymérase II. Cette enzyme est essentielle pour le processus de transcription, qui est hyperactif dans les tumeurs présentant une addiction à la transcription. L'efficacité antitumorale de la lurbinectédine fait actuellement l'objet de recherches dans le traitement de différents types de tumeurs solides, notamment cette étude de phase III pour le cancer de l'ovaire résistant au platine, une étude de phase II pour le cancer du sein métastatique associé aux gènes BRCA 1 et BRCA 2 et une étude pivot de phase III pour le cancer du poumon à petites cellules.  

À propos du cancer ovarien  

On estime qu'environ 240 000 cas seront diagnostiqués dans le monde et qu'environ 150 000 femmes mourront d'un cancer ovarien. Parmi les tumeurs malignes gynécologiques, il s'agit du deuxième cancer le plus fréquent et celui qui provoque le plus grand nombre de décès[i]. Lors du diagnostic, la plupart des patientes atteintes d'un cancer ovarien présentent un stade avancé de la maladie dont la propagation a commencé[ii]. Afin de supprimer la majeure partie de la tumeur, la chirurgie de réduction tumorale est généralement suivie d'une chimiothérapie. Cependant, environ 80 % des patientes rechutent après un traitement impliquant du platine ou un taxane et ne peuvent bénéficier d'autres alternatives thérapeutiques[iii]. 

i. Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray, F. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide (Incidence du cancer et mortalité dans le monde) : IARC CancerBase n° 11 [Internet]. Lyon (France) : Centre international de recherche sur le cancer ; 2013. Disponible sur le site : http://globocan.iarc.fr, dernier accès le 15 avril 2015.

ii. http://www.cancer.org/cancer/ovariancancer/  

iii. Ann Oncol (2013) 24 (suppl. 10) : x69-x76.doi : 10.1093/annonc/mdt475

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