Safety and Biological Activity of InfraDure Biopump Secreting Sustained Interferon in HCV Patients

Summary

This will be a Phase I-II, open-label, single center, uncontrolled, dose-escalation study. The trial will be conducted in Israel at the Tel Aviv Sourasky Medical Center. All subjects will receive autologous InfraDure Biopump (micro-organ of dermis processed ex vivo transduced with genetic construct containing the gene for interferon)tissue implants intended to provide sustained production and delivery of therapeutic levels of INF for up to twenty four (24) weeks following INFRADURE Biopump implantation. Follow up will continue for a total of two years post INFRADURE Biopump implantation

Timeline

Start

2012-10

Primary completion

2013-10

Completion

2014-03

Outcome

Outcome not reported

Stopped (Business): “Company strategic decision”

Drugs

Indications