Spain’s Zeltia says that its PharmaMar subsidiary has begun an international Phase II clinical trial to evaluate the safety and efficacy of its lead compound Yondelis in patients with metastatic breast cancer.
Zeltia said that the stratified trial will initially enrol 108 patients at 15 medical institutions in Italy, France, Israel and Poland and at 23 centres in the USA, through the participation of the US Oncology Group. If initial results are positive, the Yondelis (trabectedin) study will continue as a pivotal trial, enrolling up to 321 patients.
PharmaMar is waiting to hear from the European Agency for the Evaluation of Medicinal Products as to whether Yondelis will be approved as a second-line treatment for advanced soft tissue sarcoma. Earlier this year, its US partner Johnson & Johnson said it is not likely to present Yondelis to the US Food and Drug Administration for the latter indication this year but a filing for the treatment in the more lucrative indication of ovarian cancer is expected to be made next year.
PharmaMar secures 50 million euro loan
The news follows last week’s announcement that PharmaMar has signed a 50 million euro loan deal with the EU’s financing institution, the European Investment Bank, and the Instituto de Crédito Oficial, a state-owned corporate entity attached to the Spanish Ministry of Economy and Finance.
The ten-year loan includes a three-year ‘grace period’ and Zeltia said that the cash helps to guarantee future R&D investment as well as strengthen the group’s overall financial structure. This is the first time that both entities have financed a biotechnology company in Spain.