PV-10 For Metastatic Liver Cancer

Future Plans

• A Phase 1 trial, currently in progress, is exxpected to be completed in 2011.
• Well over 176 cancer patients have been treated with PV-10, including 12 in a Phase 1 recurrent breast cancer study, 6 in a Phase 1 metastatic liver cancer study, 20 in a Phase 1 melanoma study, 80 in a Phase 2 melanoma study, and well over 50 patients have enrolled in the Compassionate Use Program for PV-10. Additionally, 8 of the 80 Phase 2 melanoma study subjects are continuing treatments in the Compassionate Use Program.

Phase 1 Clinical Trial

• In April 2011, PV-10 received Orphan Drug Designation from the US FDA for the treatment of liver cancer.
• In January 2011, patient accrual and treatment of all six subjects was completed. Preliminary results show the treatment was generally well-tolerated, with substantial evidence of efficacy.
• In September 2010, enrollment was completed for the first dose cohort of three subjects. The therapy was very well tolerated by all three subjects treated, with substantial evidence of efficacy.
• In July 2010, it was reported that encouraging results were seen in two subjects following treatment of inoperable hepatocellular carcinoma tumors.
• In October 2009, subject enrollment began at Sharp Memorial Hospital in San Diego. The principal investigator at this clinical site is Paul Goldfarb, M.D.
• A Phase 1 study was initiated in October 2009 to evaluate the safety, tolerability, pharmacokinetics and effect on tumor growth following a single intralesional injection of PV-10 in subjects with either recurrent hepatocellular carcinoma (HCC) or cancer metastatic to the liver. In each of two planned dose cohorts there will be three subjects. Dose escalation will occur following assessment of safety and tolerability in the first cohort.

  Primary Outcome Measures:

  • Safety. Systemic and locoregional Adverse Events (AEs) will be graded by CTCAE v3.0 and coded according to MedDRA. AE data for all subjects in the first cohort will be assessed prior to dose escalation. Final assessment use AE data for all subjects. [ Time Frame: 28 days ]

  Secondary Outcome Measures

  • Lesion distribution and retention of PV-10 following injection. [ Time Frame: 28 days ]
  • Objective response rate (ORR) of Target and measurable Bystander Lesions (if present) by modified RECIST. [ Time Frame: 28 days ]
  • Changes in markers of hepatic function, including ALP, ALT, AST, total bilirubin and GGT. [ Time Frame: 28 days ]
  • Pharmacokinetics of PV-10 in the bloodstream following intralesional injection. Samples will be obtained immediately prior to PV-10 injection and at 2, 4, 8, 24 and 72 hours, and 7, 14 and 28 days to assess uptake and excretion of PV-10. [ Time Frame: 28 days ]