“Watershed Event in the Development of
PV-10” – Eric Wachter, CTO
Provectus Biopharmaceuticals, Inc. (NYSE MKT:PVCT,
www.pvct.com), a clinical-stage oncology and dermatology
biopharmaceutical company ("Provectus" or “The Company”), today
announced that an article has been published detailing the
immuno-ablative mechanism of action of PV-10, the Company’s novel
investigational drug for cancer.
The article, titled, “Intralesional Rose Bengal in Melanoma
Elicits Tumor Immunity Via Activation of Dendritic Cells by the
Release of High Mobility Group Box 1,” appears as an advance
publication in Oncotarget, an Open-Access journal, and can be
accessed by visiting:
http://dx.doi.org/10.18632/oncotarget.9247.
The article documents results of a multi-year, multidisciplinary
translational medicine program led jointly by Shari Pilon-Thomas
and Amod A. Sarnaik of Moffitt Cancer Center in Tampa, Florida. The
authors report detailed data on the mode in which intralesional
injection of PV-10 (rose bengal) selectively kills tumor cells and
the immunologic signaling that results from tumor ablation,
starting with release of High Mobility Group Box 1 (HMGB1, a
Damage-Associated Molecular Pattern molecule released by dying
cancer cells that can serve as an immunological adjuvant to promote
phagocytosis, antigen-presentation, and dendritic cell activation).
The authors then follow this signaling through antigen uptake and
dendritic cell activation, T cell priming and activation in
peripheral blood, and culminating in a tumor-specific immune
response marked by T cell infiltration and regression of uninjected
tumors.
Eric Wachter, CTO of Provectus, observed, “The Moffitt
researchers have systematically documented each of the key steps in
the immuno-oncology cycle described by Chen and Mellman in their
landmark review article (Oncology Meets Immunology: the
Cancer-Immunity Cycle. Immunity 2013; 39: 1-10). In an exemplary
demonstration of translational medicine, this team identified
important immunologic markers in model systems and verified key
facets of these in clinical trial participants, and similarly
identified other markers in clinical trial participants and
substantiated these in mouse models. While a number of their main
observations were previously reported at scientific meetings, these
are presented here in detailed, integrated fashion for the first
time.”
Shari Pilon-Thomas of Moffitt, stated, “Concordance of
tumor-specific T cells in peripheral blood of clinical trial
participants and mice led us to look for triggers of T cell
activation. Working back from these observations, we found that
HMGB1 release was common in mouse and man after tumor ablation with
PV-10. These results support PV-10 ablation and the resulting tumor
necrosis as the upstream trigger for systemic anti-tumor
response.”
Wachter noted, “This paper is a watershed event in the
development of PV-10, walking the reader through all the steps of
immune activation after PV-10 injection, from immunogenic cell
death and signaling via release of HMGB1, dendritic cell
recruitment and infiltration into draining lymph nodes, activation
of tumor-specific T cells, and killing of uninjected tumors upon
infiltration by these T cells.”
Wachter added, “This mechanism of action informed the design of
the two active PV-10 clinical trials: NCT02288897 in patients with
locally advanced cutaneous melanoma (melanoma limited to the skin)
to test the hypothesis that PV-10 alone can produce a systemic
immune response that translates to longer progression free survival
(PFS); and NCT02557321 in patients with later stage melanoma to
test whether combination of PV-10 with the recently approved
systemic immunotherapy, pembrolizumab, can 'induce and boost' an
immune response against melanoma.”
About Provectus Biopharmaceuticals, Inc.
Provectus Biopharmaceuticals, Inc., specializes in developing
oncology and dermatology therapies. PV-10, its novel
investigational drug for cancer, is designed for injection into
solid tumors (intralesional administration), thereby 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. PH-10, its topical
investigational drug for dermatology, is undergoing clinical
testing for psoriasis and atopic dermatitis. Provectus has
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: This release contains
"forward-looking statements" as defined under U.S. federal
securities laws. These statements reflect management's current
knowledge, assumptions, beliefs, estimates, and expectations and
express management's current views of future performance, results,
and trends and may be identified by their use of terms such as
"anticipate," "believe," "could," "estimate," "expect," "intend,"
"may," "plan," "predict," "project," "will," and other similar
terms. Forward-looking statements are subject to a number of risks
and uncertainties that could cause our actual results to materially
differ from those described in the forward-looking statements.
Readers should not place undue reliance on forward-looking
statements. Such statements are made as of the date hereof, and we
undertake no obligation to update such statements after this
date.
Risks and uncertainties that could cause our actual results to
materially differ from those described in forward-looking
statements include those discussed in our filings with the
Securities and Exchange Commission (including those described in
Item 1A of our Annual Report on Form 10-K for the year ended
December 31, 2015) and the following:
- our determination, based on guidance
from the FDA, whether to proceed with or without a partner with the
fully enrolled phase 3 trial of PV-10 to treat locally advanced
cutaneous melanoma and the costs associated with such a trial if it
is necessary to complete (versus interim data alone);
- our determination whether to license
PV-10, our investigational drug product for melanoma and other
solid tumors such as cancers of the liver, if such licensure is
appropriate considering the timing and structure of such a license,
or to commercialize PV-10 on our own to treat melanoma and other
solid tumors such as cancers of the liver;
- our ability to license PH-10, our
investigational drug product for dermatology, on the basis of our
phase 2 atopic dermatitis and psoriasis results, which are in the
process of being further developed in conjunction with mechanism of
action studies; and
- our ability to raise additional capital
if we determine to commercialize PV-10 and/or PH-10 on our own,
although our expectation is to be acquired by a prospective
pharmaceutical or biotech concern prior to commercialization.
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version on businesswire.com: http://www.businesswire.com/news/home/20160513005111/en/
Provectus Biopharmaceuticals, Inc.Peter R. Culpepper,
866-594-5999 #30Interim CEO, COOorPorter, LeVay & Rose,
Inc.Marlon Nurse, 212-564-4700DM, SVP – Investor RelationsorAllison
+ PartnersTodd Aydelotte, 646-428-0644Managing Director – Media
RelationsorFor Stem For Life:Allison+PartnersLinda Burns,
+1-646-428-0606Linda@allisonpr.com
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