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news.Provectus Pharmaceuticals has announced that the first 25% of melanoma subjects have been treated in its Phase II clinical trial of PV-10.
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Additional subjects are being evaluated for eligibility for entrance into the trial or are awaiting treatment at the two active centers in Brisbane and Sydney, Australia.
In addition, Provectus anticipates opening the first US site for the trial in the very near future. Currently, Provectus is also sponsoring Phase II trials for psoriasis and atopic dermatitis in New York and Florida.
Craig Dees, CEO of Provectus, said: “This milestone is significant because as soon as the data for these initial subjects, the first of whom was treated in September 2007, are reviewed a number of potential options on regulatory path may be evident.
“These could include meeting with regulatory authorities to assess potential for accelerated approval for melanoma based on anticipated results from the full Phase II study.”