Provectus Expands Protocol for Phase 1 Liver Cancer Study
Business Wire News Release
PVCT
Provectus Pharmaceuticals Inc
2012-09-27T06:15:00-04:00
Two Additional Study Cohorts to Evaluate PV-10 as Mono-and Combination Therapy
KNOXVILLE, Tenn.--(BUSINESS WIRE)--Sep. 27, 2012-- Provectus Pharmaceuticals, Inc. (OTC BB: PVCT,
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.
About Liver Cancer
Malignant lesions in the liver arising from primary hepatocellular carcinoma (HCC) or metastases from a wide
range of cancers represent an ongoing treatment challenge for oncologists. HCC is one of the most common
malignancies worldwide, and its incidence is rapidly increasing in the United States. Liver cancer is the third
leading cause of deaths related to cancer in the world, with more than 700,000 people being newly diagnosed
each year. The world market for liver cancer drugs is projected to exceed $2 billion by the year 2015*.
(*Global Industry Analysts, Inc.)
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