(ChemotherapyAdvisor) – Provectus Pharmaceuticals (Knoxville, TN) has received guidance from the U.S. Food and Drug Administration (FDA) to move forward with Phase 3 clinical trials for PV-10, an injectable formulation of Rose Bengal, which had previously shown an ability to destroy melanoma tumors with minimal damage to surrounding tissues. The news comes just 2 weeks after the company announced that they will be presenting final Phase 2 data on PV-10 at the upcoming 2nd European Post-ASCO Melanoma Meeting 2012, Interdisciplinary Global Conference on Developing New Treatments for Melanoma, on June 22, 2012, in Munich, Germany.
In Phase 2 trials, patients were highly responsive to treatment with PV-10, with regression seen in 50% of all injected tumors. Approximately 50% of patients who experienced a local tumor response also experienced a response in a distant tumor that had not been injected. The distant response is very encouraging, as it demonstrates activation of systemic anti-tumor immunity.
According to Provectus Pharmaceuticals, Phase 2 trials for PV-10 demonstrated a mean Progression Free Survival (PFS) of 8.2 months for all subjects, while the overall response cohort had a significantly longer PFS estimated to be 11.7 months vs. 4.1 months for stable disease or progressive disease subjects; subjects with cutaneous or nodal disease achieved a mean PFS of 8.8 months vs. 6.2 months for subjects with visceral metastases.
“Provectus Pharmaceuticals is seeking consensus from FDA on a Phase 3 study design that will qualify for Special Protocol Assessment for PV-10 and support FDA approval,” the company wrote.