Yondelis , Dossier Ovario podria ser presentado ante la EMEA a partir del proximo viernes 14 de Noviembre 08 . Publicado por Thomson Reuters .

....Zeltia plans to submit Yondelis for the treatment of ovarian cancer to the European Medicines Agency between mid-November and mid-December.

If Yondelis is approved for ovarian cancer treatment, the drug will have a sales potential of 1 billion euros a year, a target which the company hopes to reach by 2012. (Reporting by Tracy Rucinski; Editing by Chris Wickham) ....

Yondelis , J&J inicia ensayo clinico a nivel Mundial para evaluar si hay alteraciones en el corazon a traves de ECG en pacientes tratados .

Esperemos que desde Zeltia nos expliquen el potencial de dicho ensayo recien iniciado por J&J .....

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Single Blind, Single Group Assignment, Safety Study

Official Title: A Single-Blind, Multicenter, Placebo-Controlled, Sequential Design Study Evaluating the Potential Effects of a Single-Dose Administration of Trabectedin on the QT Intervals of the Electrocardiogram

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
The purpose of the study is to determine the effects of trabectedin on the heart's electrical cycle as measured by electrocardiograms (ECGs) in patients with advanced cancer.

Secondary Outcome Measures:
Assess the safety and pharmacokinetics of trabectedin.