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news.Provectus Pharmaceuticals has met the Australian Therapeutic Goods Administration (TGA), a part of the Australian Government's Department of Health and Ageing, for the second time to discuss milestones for approval of PV-10 for treatment of metastatic melanoma.
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PV-10 is a proprietary, injectable formulation of Rose Bengal, a small molecule agent that has been in use for nearly 30 years by ophthalmologists to assess damage to the eye. It has also been used as an intravenous diagnostic to detect ailments of the liver.
The meeting was focused on manufacturing, characterisation and specifications for PV-10, along with a review of clinical data and anticipated Phase 3 study design and endpoints.
The proposed primary endpoint of progression free survival, which Provectus proposed to the US Food and Drug Administration (FDA) earlier this year in its first end-of-Phase-2 meeting with FDA, was deemed appropriate for assessment of efficacy in light of established European Medicines Agency (EMEA) standards adopted by TGA.
Use of interim data from the first half of Phase 3 study subjects, in conjunction with safety data collected in earlier studies of PV-10 for melanoma, was discussed to allow early evaluation for marketing approval for metastatic melanoma, and TGA agreed that these data should be sufficient for this review if the analysis confirmed efficacy.
Provectus Pharma chairman and CEO Craig Dees said that they are excited about PV-10’s potential to play a role in addressing this challenging disease.
"This meeting helps clarify the path to commercialisation in this key market, and is consistent with our efforts to define that path in the US," Dees said.