FDA GIVES GUIDANCE FOR PROVECTUS TO MOVE FORWARD WITH PHASE 3 CLINICAL TRIALS OF PV-10

Story Summary

ACCORDING TO THE AMERICAN CANCER SOCIETY THERE WILL BE MORE THAN SEVENTY FIVE THOUSAND CASES OF MELANOMA AND OVER NINE THOUSAND DEATHS THIS YEAR.

PROVECTUS PHARMACEUTICALS HAS BEEN GIVEN GUIDANCE BY THE FDA TO MOVE AHEAD WITH PHASE 3 CLINICAL TRIALS OF PV-10 — A LOCAL INJECTABLE FORMULATION OF ROSE BENGAL, WHICH CAN DESTROY MELANOMA TUMORS WITHOUT HARMING SURROUNDING TISSUE.

DOCTOR SANJIV AGARWALA, CHIEF OF MEDICAL ONCOLOGY AND HEMATOLOGY, ST. LUKE'S CANCER CENTER:

"PV-10 showed a high response rate in Phase 2 clinical trials, with regression seen in 50 percent of injected tumors. Moreover, about 50 percent of patients who had a local response also demonstrated a distant response in a tumor that had not been injected. Recent studies are very encouraging as they have confirmed that PV-10 chemoablation of melanoma lesions leads to a systemic response and systemic anti-tumor immunity."

PROVECTUS IS SEEKING CONSENSUS ON A PHASE 3 STUDY DESIGN THAT WILL QUALIFY FOR SPECIAL PROTOCOL ASSESSMENT FOR PV-10 AND SUPPORT FDA APPROVAL

FOR MORE VISIT, PVCT.COM.

I'M WES BENTER.