ASCO 2010 Presentation

Additional positive data from the Phase 2 clinical trial of PV-10 for meastatic melanoma was presented at the American Society of Clinical Oncology 2010 Annual Meeting. The data, on changes in visceral and nodal metastases following chemoablation of cutaneous melanoma lesions with PV-10, was presented by Dr. Sanjiv Agarwala, Prinipal Investigator for the phase 2 clinical study of PV-10 for metastatic melanoma conducted at St. Luke's Hospital & Health Network in Bethlehem, PA. Positive improvement observed in these remote, untreated lesions, including metastases to the lungs, liver and brain, illustrate a potential systemic effect in visceral organs to which melanoma has spread. Dr. Agarwala's updated information included data from both the initial 40 subjects and the final 40 subjects enrolled in the Phase 2 trial.

The presentation poster is available as a PDF download.

For further information on PV-10 for melanoma, please see our Melanoma Clinical Trial Update page.

Presentation Highlights

Key 52-week data from the first 40 subjects in the Phase 2 study included:

• Objective Response of PV-10 injected lesions was achieved in 60% of subjects, with a Complete Response ("CR") in 33% of subjects and locoregional disease control (Stable Disease, "SD", or better) in 80% of subjects
• An OR was achieved in untreated bystander lesions in 43% of subjects having an evaluable bystander lesion at baseline
• Mean Progression Free Survival ("PFS") was 8.5 months for all subjects, while the OR cohort had a significantly longer PFS estimated to be at least 11.1 months vs. 3.0 months for SD and Progressive Disease ("PD") subjects
• PV-10 was well tolerated, with Adverse Experiences ("AEs") that were generally mild to moderate, locoregional and transient, with no deaths or life-threatening experiences attributable to PV-10

Key conclusions from the poster were that:

• A majority of subjects exhibited a robust response in their injected lesions
• Response appeared to be unrelated to disease stage or prior treatment history
• Locoregional treatment with PV-10 may elicit systemic benefit in untreated visceral lesions
• The overall safety and efficacy profile of PV-10 compares favorably with available and emerging options for metastatic melanoma patients