PV-10 For Recurrent Breast Cancer

Overview

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.

Status

  • 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.
  • Over 270 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, 10 in an investigator-initiated study of PV-10 chemoablation followed by radiotherapy, and over 140 patients enrolled in the Compassionate Use Program for PV-10. Additionally, 11 of the 80 Phase 2 melanoma study subjects continued with 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 tolerated 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) ]

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