Provectus Pharmaceuticals, Inc. (OTC BB: PVCT, http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, announced today that it has completed enrollment in the first of two dose cohorts in its Phase 1 clinical trial of PV-10 for liver cancer, and that the therapy was very well tolerated by all three subjects treated, with substantial evidence of efficacy.
The Phase 1 study consists of two cohorts of three subjects each who receive a single dose of PV-10 to a single inoperable liver lesion. The initial three subjects received PV-10 at a dose of 0.25 mL PV-10 per cc lesion volume. As none of the initial three subjects experienced significant toxicity over their 28-day follow-up interval, the second cohort of three subjects are expected to be enrolled soon and will similarly be treated with PV-10 administered at a dose of 0.50 mL per cc Lv.
Timothy Scott, Ph.D., President of Provectus Pharmaceuticals presented this new information today at the Rodman & Renshaw 12th Annual Healthcare Conference in New York City. Dr. Scott also stated that the rate of patient accrual has increased for the Phase 1 trial, and Provectus has begun planning a Phase 2 study to support possible accelerated approval of PV-10 for liver cancer.
Craig Dees, Ph.D., CEO of Provectus said, "Based upon the initial results of our PV-10 Phase 1 trial for liver cancer, and the growing confidence we have in PV-10 as a viable treatment for non-resectable liver cancer, we are currently designing a Phase 2 study. These results provide us further reasons to be excited about PV-10's potential as a safe and effective therapy for not only melanoma, but other cancers such as liver and breast cancer."
Dr. Scott's presentation, in which he discussed the Company's clinical development of PV-10 for metastatic melanoma, liver cancer, and other cancer indications, as well as PH-10 for dermatological indications, can be found at the following link: http://www.wsw.com/webcast/rrshq18/pvct
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