PV-10 For Recurrent Breast Cancer

Future Plans

• Based on positive safety and tolerability results of the Phase 1 study, as well as histologic evidence of tumor ablation or shrinkage in several subjects, Provectus is well positioned for a Phase 2 study of PV-10 for recurrent breast cancer.
• 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 October 2008, the Phase 1 study was completed successfully. 12 subjects received IL PV-10 treatment. Treatment was well tollerated in all subjects, with no evidence of systemic or serious local side effects. Several subjects exhibited evidence of efficacy, including tumor ablation or shrinkage.
• In May 2006, based on safety results from the initial treatment group, the study was expanded to include additional ascending dose cohorts.
• In April 2006, the initial group of 5 subjects completed treatment. Treatment with PV-10 was well tolerated by all five subjects.
• In December 2005, the first patient completed IL PV-10 treatment.
• In October 2005, subject enrollment began at Christchurch Hospital in Christchurch, New Zealand. The principal investigator at this clinical site is Chris Wynne, M.D.
• A Phase 1 study was initiated in October 2005 to investigate the safety of intralesional (IL) PV-10 for the treatment of recurrent breast carcinoma. This study will also include a preliminary assessment of response of injected lesions by histologic assessment upon lesion excision at 1-3 weeks following IL PV-10 administration. Post-excision wound healing will be assessed clinically at 1 week and 4 weeks following excision of PV-10 injected lesions.

  Primary Outcome Measures:

  • Systemic and locoregional adverse experience [ Time Frame: 5-7 weeks post dosing (4 weeks post excision) ]

  Secondary Outcome Measures

  • Histopathologic response of PV-10 injected lesions [ Time Frame: 7-21 days post dosing ]
  • Wound healing of PV-10 injected lesions [ Time Frame: 5-7 weeks post dosing (4 weeks post excision) ]