Provectus' PV-10 well tolerated, meets safety endpoints in phase 1 breast cancer trial

By Lisa Kerner

Erie, Pa., April 27 - Provectus Pharmaceuticals, Inc. said its initial phase 1 clinical trial of PV-10 (known as Provecta) for ablation of recurrent breast cancer showed the treatment was well tolerated with no evidence of systemic or serious local side effects.

The trial involved five subjects.

Several subjects showed evidence of efficacy, including tumor ablation or shrinkage, according to a company news release.

Provectus said the study met its primary endpoints of safety and preliminary efficacy assessment.

Additional follow-up of all but one of the subjects is completed, while follow up for the final subject should be completed in May.

Based on the results of the initial phase 1 trial, Provectus is expanding the study to include two additional dose groups of five subjects each to identify the appropriate dose of PV-10 for phase 2/3 studies.

PV-10 is retained in tumor cells while leaving normal tissue unharmed. In preclinical animal studies, PV-10 demonstrated selective ablation of a number of focal cancers, including breast carcinoma, melanoma and hepatocellular carcinoma.

Provectus is a Knoxville, Tenn., biopharmaceutical company developing technologies for the treatment of breast cancer, liver cancer and metastatic melanoma.

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