PV-10 ..... progress in Australia ............ (The article's text is a bit ragged for some reason)
ghiera.com
Provectus meets with the Therapeutic Goods Administration to review the way for approval of PV-10 in Australia
Published December 5, 2012 | By admin
PV-10 is one, the owner injectable formulation of Rose Bengal, a small molecule agent that has been in use for almost 30 years by ophthalmologists to assess damage to the eyes. E ‘was also used as a diagnostic for identifying intravenous liver disease. Provectus has discovered a new use for Rose Bengal based on the fact that it is selectively toxic to cancer calls via a process called chemoablation which cells undergo a form of cell death that mimics the characteristics of both necrosis and apoptosis.There are two FDA-approved CLE which, according to Wallace: The OptiScan / Pentax Technologies and Cellvizio Mauna Kea.
The recent meeting focused on the fabrication, characterization and specifications for PV-10, with a review of clinical data and provided the design of Phase 3 studies and endpoints. The test proposed primary progression-free survival, Provectus proposed that the Food and Drug Administration earlier this year in his first order of the phase-2 meeting with the FDA has considered appropriate to evaluate efficiency in the light of established European Medicines Agency standards adopted by TGA. Using preliminary data from the first half of the subjects in the Phase 3 study, in combination with safety data collected in previous 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 review, if the analysis has confirmed its effectiveness.
Provectus Pharmaceuticals, Inc., a development stage oncology and dermatology biopharmaceutical company, held its second meeting with the Australian Therapeutic Goods Administration to discuss the approval of PV-10 for the treatment of metastatic . The TGA is part of the Australian Government Department of Health and Ageing responsible for the approval of evaluation and monitoring of therapeutic products available in Australia.
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