pe26 schreef op 19 oktober 2017 23:50:
Is iedereen aan het slapen.....
WOW!!!! Celgene stopt GED-0301 studies.
Dit is mega voor Galapagos, en waarom:
Filgotinib is nu kandidaat nummer 1 om 1e orale (pil) medicijn op de markt te worden binnen ziekte van Crohn.
Dag Celgene, dag AbbVie (voorsprong +14 maanden op ABT-494).
Celgene Provides Update on GED-0301 (mongersen) Inflammatory Bowel Disease Program
Oct. 19, 2017 4:30 PM
SUMMIT, N.J.--(BUSINESS WIRE)--
Celgene Corporation (CELG) today announced that the GED-0301 (mongersen) phase III REVOLVE trial (CD-002) in Crohn’s disease (CD) and the extension trial (SUSTAIN, CD-004) will discontinue. Celgene has decided to stop the trials following an October recommendation of the Data Monitoring Committee, which assessed overall benefit/risk during a recent interim futility analysis. There were no meaningful safety imbalances identified in the analysis.
At this time, the phase III DEFINE trial (CD-003) in Crohn’s disease will not be initiated. Celgene is waiting to review the full dataset from the phase II trial with GED-0301 in ulcerative colitis (UC) to determine next steps.
“We thank the patients and the investigators involved in the REVOLVE trial,” said Scott Smith, President and Chief Operating Officer for Celgene. “Crohn’s disease is a debilitating condition with few effective long-term treatment options. While we are disappointed with the results of REVOLVE, we remain committed to advancing our portfolio of novel medicines for patients suffering from this disease and other inflammatory bowel disorders.”