Provectus expands Ph I trial of Provecta on strong data

US drugmaker Provectus says that a second group of subjects has been treated in its Phase I clinical trial of PV-10 (also known as Provecta) for ablation of metastatic melanoma, an aggressive and often fatal form of skin cancer.

According to the Knoxville, Tennessee-based firm, treatment with PV-10 was well tolerated by all subjects, with no evidence of systemic or serious local side effects. Most subjects have exhibited evidence of efficacy, ranging from tumor shrinkage to complete ablation and several also exhibited subsequent shrinkage of untreated tumors, a response characteristic of the bystander effect.

Based on these findings, the company has expanded the scope of the study to include a third group of subjects who will receive treatment of up to 20 melanoma lesions. The maximum lesion diameter will also be doubled and study eligibility expanded to include Stage IV subjects (those who have distant metastases). Provectus says that these changes will allow it to further assess the drug's performance and validate anticipated Phase II/III study design parameters where all accessible lesions are expected to be treated.