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A Phase 2 study of intralesional PV-10 in the treatment of metastatic melanoma, (study ID
PV-10-MM-02), is currently in progress. The primary objective of this study is to
investigate the effectiveness of intralesional (IL) PV-10 for locoregional treatment
of metastatic melanoma. More details of the study are available at the U.S. National
Institutes of Health
ClinicalTrials.gov website.
A Phase 1 safety and tolerability study of intralesional PV-10 chemoablation in subjects with metastatic melanoma,
(study ID PV-10-MM-01), has been completed. The objective of this study was to investigate the safety of intralesional
(IL) PV-10 for the treatment of metastatic melanoma. This study also included a preliminary assessment
of response of treated and untreated lesions by clinical evaluation at follow-up of 12 to 24 weeks
following IL PV-10 treatment. More details of this study are available at the U.S. National
Institutes of Health
ClinicalTrials.gov website.
A Rose Bengal presentation from
September 2006 includes a summary of the clinical effects of PV-10 on melanoma.
Example clinical photos illustrating response of melanoma to PV-10 may be viewed by
following this link. WARNING: These images are graphic
and may not be suitable for viewing by sensitive individuals.
The following text is an excerpt from the 8-K filed with the SEC on 10/7/2005 by Provectus:
Item 8.01. Other Events.
Provectus Pharmaceuticals, Inc., announced that Professor John F Thompson,
MD, Director of the Sydney Melanoma Unit, Camperdown, NSW, Australia, discussed
preliminary results from the metastatic melanoma clinical trial he is conducting
using the Company's lead cancer agent, PV-10. Professor Thompson made his remarks
at The William and Ida Friday Center for Continuing Education of The University of
North Carolina at Chapel Hill on October 6, 2005, as part of the course "Current
Management of Melanoma: A Multidisciplinary Perspective." The Company expects
additional information on this clinical study (PV-10-MM-01, details available at
www.ClinicalTrials.gov)
to be available in early 2006.
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