Provectus Expands Protocol for Phase 1 Liver Cancer Study
Provectus Expands Protocol for Phase 1 Liver Cancer Study
Two Additional Study Cohorts to Evaluate PV-10 as Mono-and Combination Therapy
KNOXVILLE, Tenn.--(BUSINESS WIRE)-- 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.
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.)
The European Association for the Study of the Liver (2D EASL) is the leading liver association in Europe, attracting leading hepatology experts as members to promote research in and education about liver disease, as well as change in European liver policy.
About Provectus Pharmaceuticals, Inc.
Provectus Pharmaceuticals specializes in developing oncology and dermatology therapies. Its novel oncology drug PV-10 is designed to selectively target and destroy cancer cells without harming surrounding healthy tissue, significantly reducing potential for systemic side effects. Its oncology focus is on melanoma, breast cancer and cancers of the liver. The Company has received orphan drug designations from the FDA for its melanoma and hepatocellular carcinoma indications. Its dermatological drug PH-10 also targets abnormal or diseased cells, with the current focus on psoriasis and atopic dermatitis. Provectus has recently completed Phase 2 trials of PV-10 as a therapy for metastatic melanoma, and of PH-10 as a topical treatment for atopic dermatitis and psoriasis. Information about these and the Company's other clinical trials can be found at the NIH registry, www.clinicaltrials.gov. For additional information about Provectus please visit the Company's website at www.pvct.com or contact Porter, LeVay & Rose, Inc.
FORWARD-LOOKING STATEMENTS: The forward-looking statements contained herein are subject to certain risks and uncertainties that could cause actual results to differ materially from those reflected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect management's analysis only as of the date hereof. The company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date thereof.
Provectus Pharmaceuticals, Inc.
Peter R. Culpepper, CFO, COO
Porter, LeVay & Rose, Inc.
Marlon Nurse, DM, SVP - Investor Relations
Bill Gordon, SVP - Media Relations
KEYWORDS: United States North America Tennessee
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