KNOXVILLE, TN--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."
About Provectus Pharmaceuticals, Inc.
Provectus Pharmaceuticals specializes in developing oncology and dermatology therapies that are safer, more effective and less invasive than conventional therapies. Provectus is currently conducting clinical trials of their proprietary drugs Provecta(TM) (PV-10) as a therapy for melanoma and breast cancer, as well as Xantryl(TM), a topical treatment for severe psoriasis and eczema. Further, use of Provecta for melanoma has received orphan drug designation from the FDA. Additionally, the company is about to begin Phase 2 of clinical testing for Xantryl for psoriasis. For additional information about Provectus please visit the company's website at www.pvct.com or contact The Investor Relations Group via the information provided below.
FORWARD-LOOKING STATEMENTS: The forward-looking statements contained herein are subject to certain risks and uncertainties that could cause actual results to differ materially from those reflected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect management's analysis only as of the date hereof. The company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date thereof.