Provectus Pharmaceuticals, Inc. (OTC BB: PVCT, http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, has held its second meeting with the Australian Therapeutic Goods Administration ("TGA") to discuss milestones for approval of PV-10 for treatment of metastatic melanoma. The TGA is the part of the Australian Government's Department of Health and Ageing responsible for the assessment, approval and monitoring of therapeutic goods available in Australia. The initial meeting with the TGA was held in October 2008.
“Australia has one of the highest rates of metastatic melanoma in the world, and for obvious reasons is an enormous public health concern”
The recent meeting focused on manufacturing, characterization 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 U.S. 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.
Metastatic melanoma is the fourth most common cancer in Australia, with more than 9,500 new cases diagnosed each year, and 1,270 deaths caused by the disease, according to the Australian Institute of Health and Welfare & Australasian Association of Cancer Registries. Melanoma incidence rates in Australia are approximately four times as high as those in the U.S., Canada and the U.K.
"Australia has one of the highest rates of metastatic melanoma in the world, and for obvious reasons is an enormous public health concern," said Craig Dees, Ph.D., Chairman and Chief Executive Officer of Provectus. "We are excited about PV-10's potential to play a role in addressing this very challenging disease. This meeting helps clarify the path to commercialization in this key market, and is consistent with our efforts to define that path in the United States."
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