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Provectus Pharmaceuticals Announces H. Lee Moffitt Cancer Center Initiates Phase 1 Study of PV-10 to Elucidate Bystander Effect
KNOXVILLE, Tenn. --(Business Wire)--
Provectus Pharmaceuticals, Inc. (OTCBB: PVCT) (http://www.pvct.com),
a development-stage oncology and dermatology biopharmaceutical company,
reports that the Moffitt
Cancer Center has initiated a Phase 1 study to investigate potential
immune biomarkers in both tumor tissue and peripheral blood after
intralesional ("IL") PV-10 injection of melanoma tumors.
Amod Sarnaik, M.D. member of the Experimental Therapeutics Program at
Moffitt and faculty member at the University of South Florida, is the
principal investigator for the study, which is expected to enroll up to
15 subjects. Sarnaik said, "We look forward to verifying the promising
pre-clinical data from our ongoing work in this translational study.
These results should help elucidate the immunologic basis of the
'bystander effect' noted in previous clinical studies of PV-10 and help
optimize PV-10 treatment, particularly in combination with other
therapies. As Moffitt pursues its mission of contributing to the
prevention and cure of cancer, we are pleased to spearhead this
important clinical work."
Craig Dees, Ph.D., CEO of Provectus said, "We are delighted that Moffitt
has initiated this clinical trial. We believe that the mechanism by
which PV-10 can cause regression of un-injected lesions is novel.
Although this study is separate from our expected registration pathway
(study of PV-10 in melanoma patients with locoregional disease
accessible to PV-10 treatment), this work is very important as it will
help us to better understand the potential systemic benefit of PV-10
treatment, and suggest logical therapeutic combinations that may augment
the apparent immune response to PV-10 treatment in cancer patients with
substantial tumor burden.
About Moffitt Cancer Center
Locaed in Tampa, Moffitt is one of only 41 National
Cancer Institute-designated Comprehensive Cancer Centers, a
distinction that recognizes Moffitt's excellence in research, its
contributions to clinical trials, prevention and cancer control. Since
1999, Moffitt has been listed in U.S.
News & World Report as one of "America's Best Hospitals"
for cancer. With more than 4,200 employees, Moffitt has an economic
impact on the state of nearly $2 billion. For more information, visit MOFFITT.org,
and follow the Moffitt momentum on Facebook,
twitter
and YouTube.
About Provectus Pharmaceuticals, Inc.
Provectus Pharmaceuticals specializes in developing oncology and
dermatology therapies. Its novel oncology drug PV-10 is designed to
selectively target and destroy cancer cells without harming surrounding
healthy tissue, significantly reducing potential for systemic side
effects. Its oncology focus is on melanoma, breast cancer and cancers of
the liver. The Company has received orphan drug designations from the
FDA for its melanoma and hepatocellular carcinoma indications. Its
dermatological drug PH-10 also targets abnormal or diseased cells, with
the current focus on psoriasis and atopic dermatitis. Provectus has
recently completed Phase 2 trials of PV-10 as a therapy for metastatic
melanoma, and of PH-10 as a topical treatment for atopic dermatitis and
psoriasis. Information about these and the Company's other clinical
trials can be found at the NIH registry, www.clinicaltrials.gov.
For additional information about Provectus please visit the Company's
website at www.pvct.com
or contact Porter,
LeVay & Rose, Inc.
FORWARD-LOOKING STATEMENTS: The forward-looking statements contained
herein are subject to certain risks and uncertainties that could cause
actual results to differ materially from those reflected in the
forward-looking statements. Readers are cautioned not to place undue
reliance on these forward-looking statements, which reflect management's
analysis only as of the date hereof. The company undertakes no
obligation to publicly revise these forward-looking statements to
reflect events or circumstances that arise after the date thereof.

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