14th Oct 2015 10:20
LONDON (Alliance News) - Ergomed PLC Wednesday said its Canadian co-development partner Aeterna Zentaris has received a recommendation from the independent Data Safety Monitoring Board to continue the Phase 3 ZoptEC pivotal study with zoptarelin doxorubicin in women with advanced, recurrent or metastatic endometrial cancer.
The ZoptEC pivotal Phase 3 trial compares the efficacy and safety of zoptarelin doxorubicin, a hybrid molecule composed of a synthetic peptide carrier and chemotherapy agent, doxorubicin, to doxorubicin alone.
"Having completed the recruitment ahead of schedule, the trial is progressing as planned and we are very pleased with this recommendation from the DSMB to continue the Phase 3 ZoptEC study. We believe that zoptarelin doxorubicin has the potential to provide treatment for advanced, recurrent endometrial cancer, and look to continue progressing this study with Aeterna Zentaris," Chief Executive Miroslav Reljanovic said in a statement.
The trial is being conducted under a Special Protocol Assessment with the US Food and Drug Administration.
Shares in Ergomed were untraded on Wednesday, last quoted at 157.00 pence.
By Karolina Kaminska; [email protected] @KarolinaAllNews
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