RE: Crumbs29 Oct 2018 08:47
Indeed also from that file:
SCIB1 US IND and Phase 2 study
The Company's Investigational New Drug (IND) application for SCIB1 is expected to be filed with the Food
and Drug Administration (FDA) during the first half of 2018. Following the pre-IND meeting in 2017, the FDA
suggested that technical data from Ichor’s new TriGrid 2.0 clinical device should be submitted 30-60 days prior
to Scancell’s own FDA submission. Ichor has now submitted the required data to the FDA, and therefore,
subject to funding, patient enrolment into this trial is now expected to commence in the second half of 2018.
The study, which will be a Phase 2 checkpoint inhibitor combination study with SCIB1 in patients with advanced
melanoma, will be led by Principal Investigator Dr Keith Flaherty, Director of the Termeer Center for Targeted
Therapy at Massachusetts General Hospital and Associate Professor at Harvard Medical School.