Provectus announced it had expanded the protocol for Phase 1 liver cancer study to include "...the assessment of safety and efficacy in up to 24 additional patients with hepatocellular carcinoma ("HCC") or metastatic cancer of the liver (Expansion Cohort 1), as well as the safety and efficacy in up to 12 patients with HCC who are on a stable dose of sorafenib, a standard treatment for HCC (Expansion Cohort 2)." The site at which this study was going to be conducted was the same site for the original Phase 1 trial, Sharp Memorial Hospital in San Diego. The principal investigator was Dr. Paul Goldfarb, MD.
Since then, we've heard no word until recently, a few days ago, when a second site was opened: The Southeastern Center for Digestive Disorders & Pancreatic Cancer. The principal investigator is Dr. Alexander Rosemurgy, MD.
Problematic with running clinical trials, it seems, and among other things, is slowness on the part of the site and investigator to enroll and treat patients. With the opening of a second site, I hope this process is sped up. I imagine Provectus will issue a PR about the site when it enrolls and treats its first patient.
I am curious to understand whether the company has to enroll and treat all of the contemplated patients in the HCC expanded Phase 1 trial, or whether Provectus can enroll and treat a partial number in order to eventually submit an application for breakthrough therapy designation for PV-10 for HCC.