Provectus updates on PV-10 compassionate use program

Provectus said that the protocol for the compassionate use program enables subjects to undergo more frequent and extensive treatments of PV-10 over a longer period of time than was allowed under the protocol used for the Phase 2 trial of PV-10.

PV-10 is a proprietary, injectable formulation of Rose Bengal, a small molecule agent that has been in use by ophthalmologists to assess damage to the eye.

Provectus claimed that it has discovered a new use for Rose Bengal based on the observation that it is selectively toxic to cancer calls via a process called chemoablation whereby cells undergo a form of cell death that mimics both features of necrosis and apoptosis.

Provectus said that based on the success of the compassionate use program, its dose regimen is expected to serve as the blueprint for a potential Phase 3 study for metastatic melanoma.

The majority of patients enrolled in the program have been treated for melanoma, with one patient treated for both melanoma and recurrent squamous cell carcinoma.

Provectus CEO Craig Dees said that they were pleased that their compassionate use program for PV-10 is providing patients access to the therapy.

"The success of the program is in addition to the very positive results from our Phase 1 and Phase 2 melanoma trials," Dees said.

"More recently, early results from our Phase 1 liver cancer trial have also indicated that the treatment is well-tolerated with substantial evidence of potential efficacy.

"We intend to continue advancing PV-10 for both indications, and will continue providing access via the compassionate use program while we prepare for a Phase 2 mechanism of action trial and a pivotal Phase 3 melanoma trial to expedite approval in the US and abroad."