Poster Titled, “T cell Mediated Immunity After
Combination Therapy with Intralesional PV-10 and Co-Inhibitory
Blockade in a Melanoma Model” presented by Researchers at Moffitt
Cancer Center
Provectus Biopharmaceuticals, Inc. (NYSE MKT:PVCT,
www.pvct.com), a clinical-stage oncology and dermatology
biopharmaceutical company ("Provectus" or “The Company”), announced
today that researchers from Moffitt Cancer Center in Tampa,
Florida, presented a poster titled, “T cell Mediated Immunity After
Combination Therapy with Intralesional PV-10 and Co-Inhibitory
Blockade in a Melanoma Model,” at the American Association for
Cancer Research (AACR) Annual Meeting 2016, held at the Ernest N.
Morial Convention Center in New Orleans, Louisiana.
In the poster, authors Amy M Weber, Hao Liu, Krithika Kodumudi,
Amod A Sarnaik and Shari Pilon-Thomas state that “treatment with IL
PV-10 and anti-PD-1 antibody results in a delay in tumor growth and
enhanced T cell activation in the M05 tumor model.” They also
conclude that “the effect of combination therapy with IL PV-10 and
PD-1 blockade is mediated by CD8+ T cells, and depletion of either
CD4+ T cells or CD25+ Tregs enhances anti-tumor immunity in the M05
melanoma model.” The abstract of the poster (number 4978) may be
viewed at: http://www.abstractsonline.com/4978.
Shari Pilon-Thomas, Ph.D., who leads the research team at
Moffitt, noted, “Our results show that combining intralesional
PV-10 with anti-PD-1 co-inhibitory blockade not only suppresses
tumor growth vs. either agent alone but also yields marked
increases in tumor-specific T cell activation against injected
tumor.”
Eric Wachter, Ph.D., Chief Technology Officer of Provectus,
observed, "The nonclinical data reported by our collaborators at
Moffitt reaffirm the crucial role T cells play in response to tumor
ablation with intralesional PV-10, and further demonstrate the
potential value of combining PV-10 with T cell directed checkpoint
inhibition, such as the anti-PD-1 agent pembrolizumab.
Intriguingly, these data also highlight possible strategies for
augmenting this paradigm by harnessing additional targets in T cell
signaling.”
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 the American Association for Cancer Research
The mission of the American Association for Cancer Research is
to prevent and cure cancer through research, education,
communication, and collaboration. Through its programs and
services, the AACR fosters research in cancer and related
biomedical science; accelerates the dissemination of new research
findings among scientists and others dedicated to the conquest of
cancer; promotes science education and training; and advances the
understanding of cancer etiology, prevention, diagnosis, and
treatment throughout the world.
The AACR is the oldest and largest scientific organization in
the world focused on every aspect of high-quality, innovative
cancer research. Its reputation for scientific breadth and
excellence attract the premier researchers in the field. The
programs and services of the AACR foster the exchange of knowledge
and new ideas among scientists dedicated to cancer research,
provide training opportunities for the next generation of cancer
researchers, and increase public understanding of cancer.
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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160422005164/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
Relations
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