Provectus amends and expands protocol for PV-10 Phase 1 hepatocellular carcinoma study

Sep 28 2012

Provectus Pharmaceuticals, Inc. (OTC BB: PVCT, http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, announced that it has amended and expanded the scope of the protocol PV-10-LC-01, "A Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics of PV-10 Chemoablation of Cancer Metastatic to the Liver or Hepatocellular Carcinoma not Amenable to Resection or Transplant."   

The study protocol has been expanded 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). In both expansion cohorts, subjects will receive PV-10 treatment of a single hepatic tumor. Subjects with multiple injectable tumors will be eligible for re-enrollment for treatment of additional tumors if PV-10 is well-tolerated. The initial Phase 1 study had included two cohorts, each consisting of three subjects; dose escalation for the second cohort occurred following assessment of safety and tolerability in the first cohort.

Efficacy assessment will be based on a two-dimensional European Association for the Study of the Liver (2D EASL) criteria, which has been shown to correlate with clinical outcome in studies of other ablative therapies. Follow-up for the protocol is also extended from 28 days to three months to allow for assessment of response to PV-10 treatment. Dr. Paul Goldfarb, M.D., of Sharp Memorial Hospital in San Diego, is the Principal Investigator for the Phase 1 study.

Dr. Craig Dees, PhD, CEO of Provectus said, "Outcome from our initial six study subjects showed that PV-10 was generally well-tolerated, and expanding our protocol is expected to further elucidate the viability for PV-10 in treating patients with cancer of the liver. Additionally, the major expansion of the program will allow us to better assess the potential of PV-10 both as mono-therapy and in combination with standard systemic therapy so that we can complete design of crucial Phase 2 randomized controlled trials (RCTs)."

Provectus received orphan drug designation by the U.S. Food and Drug Administration in April 2011, entitling the Company to exclusive marketing rights for PV-10 for HCC in the United States for up to seven years if it is the first company to receive marketing approval for this therapeutic drug product.    

Source: Provectus Pharmaceuticals, Inc.