Provectus releases PV-10 Phase 2 study data

Reportedly, a mean Progression Free Survival (PFS) of 11.7 months was observed among subjects achieving an OR.

In the PV-10 Phase 2 trial, a complete response (CR) of PV-10 injected lesions was achieved in 24% of subjects, Partial Response (PR, requiring at least a 30% reduction in tumor volume) in 25% of subjects and Stable Disease (SD, requiring less than 20% increase in tumor volume) in 18% of subjects, with 23% of subjects experiencing disease progression (PD, 20% or greater increase in tumor volume).

Additionally, an OR was achieved in untreated bystander lesions in 37% of subjects having an evaluable bystander lesion at baseline, with 55% of subjects achieving locoregional disease control in their bystander lesions.

Bystander response was closely correlated with successful ablation of injected lesions, with 67% of subjects achieving an OR of their bystander lesions if they achieved an OR in their injected lesions vs 5% in subjects who did not achieve an OR in their injected lesions.

Provectus said that the mean progression free survival was 8.2 months for all subjects, while the OR cohort had a longer PFS estimated to be 11.7 months vs 4.1 months for SD or PD subjects; subjects with cutaneous or nodal disease achieved a mean PFS of 8.8 months vs 6.2 months for subjects with visceral metastases.

Principal investigator for the study Agarwala said that the consistently positive data on all 80 subjects in the PV-10 trial are very encouraging, particularly in light of the large number of patients in the second half of the study who had advanced melanoma.

"The excellent response rate in patients with cutaneous or nodal disease illustrates the potential of the drug for these prime candidates for PV-10," Agarwala said.

"The bystander effect, which appears to result from an immunologic response stimulated by PV-10 chemoablation, is especially intriguing. The immunologic processes whereby PV-10 produces systemic response are the topic of a Phase 2B study, whose design is being finalised."

Provectus Pharma CEO Craig Dees said that the initial full study results for all 80 subjects enrolled in the Phase 2 study were extremely gratifying as they complete the important milestone with PV-10.

"Our discussions with the Food and Drug Administration (FDA) in the US, as well as the TGA in Australia, are also continuing as we establish the pathway for commercialising PV-10," Dees said.

"We are currently incorporating guidance that we received from the FDA during our End-of-Phase 2 meeting to finalise the protocol design for a pivotal Phase 3 randomised controlled trial suitable for Special Protocol Assessment."