In the company’s news Friday,
Provectus Pharmaceuticals Inc. announced it is recruiting for its phase 2 clinical trials of PV-10 for the treatment of stage III and IV metastatic melanoma, the most deadly form of skin cancer.
The company is focusing on recruiting 80 subjects at a fourth center in Adelaide, Australia to test the efficacy of PV-10. Throughout the next several months, Provectus expects to expand its study to incorporate subjects in other areas of Australia, as well as several sites in the United States.
“Opening the center at Adelaide is the continuation of our expansion of our phase 2 program in melanoma to multiple sites including the U.S.,” Craig Dees, Ph.D., CEO of Provectus stated in the press release. “It is another important step in our effort to get the treatment available to as many patients as possible in the shortest possible time.”
Part of the study involves PV-10 being injected in up to 20 tumors found in each subject; follow-up treatment with PV-10 may be administered within eight to 16 weeks of the initial injection if necessary, and the subjects’ reactions to the treatment will be observed for one year.
In Provesctus’ phase I testing, more than 100 metastatic melanoma tumors in 20 subjects were studied. According to Dr. Dees, PV-10 was well tolerated with generally mild side effects.
“The 40 percent objective response rate and 75 percent rate of disease control observed in the initial study bode well for success of PV-10 for treatment of this most challenging of cancers,” Dr. Dees stated.
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