Date: 2015-07-06
Type of information: Presentation of results at a congress
phase: 1
Announcement: presentation of results at the 6th Asia-Pacific Primary Liver Cancer Expert Meeting (APPLE 2015)
Company: Provectus Pharmaceuticals (USA - TN)
Product: PV-10
Action
mechanism: PV-10 is an investigational new drug containing a proprietary injectable formulation of rose bengal disodium, a water-soluble xanthene dye currently in use in a topical opthalmic diagnostic. PV-10 is designed for injection into solid tumors (intralesional administration). Its oncology focus is on melanoma, breast cancer and cancers of the liver. Provectus has received orphan drug designations from the FDA for its melanoma and hepatocellular carcinoma indications .
Disease: hepatocellular carcinoma
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On July 6, 2015, Provectus Biopharmaceuticals announced that data from its phase 1 study of PV-10 for chemoablation of hepatocellular carcinoma (HCC) and cancer metastatic to the liver was presented on July 3, 2015 at the 6th Asia-Pacific Primary Liver Cancer Expert Meeting (APPLE 2015) in Osaka, Japan.
The presenter was Dr. Sanjiv Agarwala, chief of medical oncology and hematology at St. Luke's Cancer Center in Bethlehem, Pennsylvania, and professor of medicine at Temple University School of Medicine in Philadelphia, Pennsylvania. He serves as a principal investigator of the phase 1 clinical trial that produced the data presented, and is the lead investigator for the phase 3 clinical trial of PV-10 as an investigational treatment for melanoma which recently began. The poster presentation was titled "Phase 1 Study of PV-10 for Chemoablation of Hepatocellular Cancer and Cancer Metastatic to the Liver."
Based on the data presented, the researchers concluded that preliminary efficacy in treatment of liver tumors with PV-10, a 10% solution of rose Bengal, was observed with acceptable tolerability. The study is continuing at three study centers with two expansion cohorts to further assess safety and response in HCC and other cancers metastatic to the liver.
Provectus previously reported data on clinical and nonclinical testing of intralesional PV-10 as an investigational treatment for metastatic melanoma, where it has demonstrated high rates of complete response and durable local control in injected melanoma lesions. The phase 1 study reported at APPLE 2015 was designed to assess safety, pharmacokinetics and preliminary efficacy of PV-10 in subjects with non-resectable HCC or cancer metastatic to the liver.
In the phase 1 study, subjects having a target lesion in the liver at least 1 cm in diameter were administered a single percutaneous intralesional injection of PV-10 into their target lesion. Plasma concentrations of PV-10 from 1 hour to 28 days after injection were measured. Radiologic assessments of the injected target lesion were performed to determine response over an initial 28-day and longer term 9-15 month follow-up interval. Serum levels of potential liver injury markers were measured, and adverse events recorded.
In the initial study cohort, six subjects received PV-10 injections in two successive escalating dose cohorts of 0.25 and 0.50 mL per cm3 lesion volume. Significant adverse events were limited to injection site and photosensitivity reactions that resolved without sequelae. All injected tumors were stable in size at 28 days, and among four of the initial six tumors that had longer-term assessment, two had partial response.
