Provectus Pharmaceuticals, Inc. (OTCBB:PVCT) announced that it has obtained approval to begin Phase 2 clinical testing of Provecta for the treatment of Stage III and IV metastatic melanoma, the most aggressive and deadly form of skin cancer.
The multi-center study is designed to evaluate efficacy of Provecta in a total of 80 subjects.
In the study, Provecta will be injected into up to 20 tumors in each subject. Additional treatment with Provecta may be made 8 to 16 weeks after this initial injection, if deemed necessary by the investigator. Response will be observed for 1 year, during which data will be gathered for assessment of objective response rate, progression free survival, quality of life and safety.
In addition, CT imaging will be used to monitor changes in any internal (e.g., visceral or brain) metastases. The lead site for the study is the Sydney Melanoma Unit in Australia. Over the next several months the study will expand to include sites in a number of major population centers in Australia as well as several sites in the U.S.
Craig Dees, Ph.D., Chief Executive Officer of Provectus, stated, ?Building on the results from our Phase 1 study, which looked at safety and objective response upon injection of Provecta into more than 100 metastatic melanoma tumors in 20 subjects, we have put forth an aggressive clinical plan to drive toward approval of the drug for use in this devastating disease.? Dees continued, ?Preliminary analysis of data from Phase 1 shows that Provecta, which has received orphan drug designation in the U.S., was well tolerated with generally mild side effects. Having completed final follow-up for the last of these subjects, we expect to announce summary response data in the near future.?