Provectus Biopharmaceuticals Reports Immune Mechanism of Action Data for Pv-10 Presented at Society for Immunotherapy of Canc...
November 05 2015 - 5:00PM
Business Wire
Poster Titled, “Intralesional Rose Bengal in
Melanoma Elicits Tumor Immunity via High Mobility Group Box 1”
Available on Company Website
Provectus Biopharmaceuticals, Inc. (NYSE MKT:PVCT,
http://www.pvct.com), a clinical-stage oncology and dermatology
biopharmaceutical company (“Provectus”), today announced that
researchers from Moffitt Cancer Center in Tampa, Florida, presented
a poster titled, “Intralesional Rose Bengal in Melanoma Elicits
Tumor Immunity via High Mobility Group Box 1,” at the Society for
Immunotherapy of Cancer (SITC) 30th Anniversary Annual Meeting in
National Harbor, Maryland.
Authors Hao Liu, Pasquale Patrick Innamarato, Krithika Kodumudi,
Amy Weber, John L Robinson, Satoshi Nemoto, Georgina Crago, Timothy
McCardle, Erica Royster, Amod A Sarnaik and Shari Pilon-Thomas
state that their “results reveal a clinically relevant
immunoadjuvant pathway triggered by tumor cell death secondary to
ablation with RB.” The data presented were from nonclinical models
of melanoma in mice and clinical data from the team’s recent
clinical mechanism of action study (Clinical Trials ID
NCT01760499). To view the poster, visit http://www.pvct.com/publications/SITC-Poster-2015.pdf.
In the reported work, the authors showed that tumor-specific T
cells were increased in the blood of both mouse and man after tumor
ablation with PV-10. This was initiated by tumor cell necrosis,
leading to release of High Mobility Box Group 1 (HMBG1), one of a
class Damage-Associated Molecular Pattern molecules (DAMPs)
released by dying cancer cells that can lead to activation of
dendritic cells. HMBG1 release was observed in vitro and after
ablation of melanoma tumors in mice and clinical trial
participants. This was also correlated with dendritic cell
activation and infiltration into lymph nodes draining ablated
tumors.
Eric Wachter, Ph.D., Chief Technology Officer of Provectus,
observed, “The data reported by our collaborators at Moffitt
further clarify the mechanism by which tumor ablation with PV-10
can initiate a finely tuned immune response against injected tumor
cells. This has important potential implications for overall
response and durability of response when PV-10 is used as a single
agent therapy, while the central role played by T cells in this
response is notable for combination of PV-10 with other agents that
function on T cells.”
Provectus is currently enrolling patients in a phase 3 study of
PV-10 as a single agent therapy for patients with locally advanced
cutaneous melanoma (Clinical Trials ID NCT02288897) and in a phase
1b study of PV-10 in combination with the immune checkpoint
inhibitor pembrolizumab in patients with metastatic melanoma
(Clinical Trials ID NCT02557321).
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, 2014) 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, PH-10, 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/20151105006725/en/
Provectus Biopharmaceuticals, Inc.Peter R. Culpepper, CFO,
COO866-594-5999 #30orPorter, LeVay & Rose, Inc.Marlon Nurse,
DM, SVP – Investor Relations212-564-4700orTodd Aydelotte - Media
Relations646-428-0644
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