Delcath Systems adds new clinical sites for FOCUS trial to treat ocular melanoma liver metastases

11th October 2016 (Last Updated October 11th, 2016 18:30)

Delcath Systems has announced that five new clinical trial sites in the US have been added to its global FOCUS Phase 3 clinical trial for patients with hepatic dominant ocular melanoma.

Delcath Systems has announced that five new clinical trial sites in the US have been added to its global FOCUS Phase 3 clinical trial for patients with hepatic dominant ocular melanoma.

These accredited centres join several other centres as active participants in the FOCUS trial.

Delcath currently has a total of eight cancer centres in the US open for patient enrolment in the FOCUS Trial. 

The new participating centres are Ohio State University Comprehensive Cancer Center, MD Anderson Cancer Center, Thomas Jefferson University Sidney Kimmel Cancer Center, University of Chicago Comprehensive Cancer Center and University of Maryland Greenebaum Cancer Center.

"Interest in the FOCUS Trial has been strong, and we expect to achieve our goal of activating approximately 30 centres in both the US and Europe in the coming months."

FOCUS is a global Phase 3 clinical study analysing the safety, efficacy and pharmacokinetic profile of the company's Melphalan / HDS system compared to best alternative care in 240 patients with ocular melanoma liver metastases.

The trial's primary endpoint is a comparison of overall survival between the two study arms, while secondary and exploratory endpoints include progression-free survival, overall response rate, and quality-of-life measures.

It is being carried out under a Special Protocol Assessment (SPA) with the US Food and Drug Administration (FDA).

The SPA has agreed that the Phase 3 trial design sufficiently meets objectives supporting the submission for regulatory approval of Melphalan / HDS.

Delcath Systems president and chief executive officer Jennifer K. Simpson said: "We are pleased to add these respected cancer research institutions to our FOCUS Trial and to expand the regional coverage available to patients in the US with ocular melanoma liver metastases.

"Interest in the FOCUS Trial has been strong, and we expect to achieve our goal of activating approximately 30 centres in both the US and Europe in the coming months."