Provectus Biopharmaceuticals Reports Data On PV-10 in Combination Therapy and T Cell Mediated Immunity Presented at American Association for Cancer Research (AACR) Annual Meeting 2016

- April 22nd, 2016

KNOXVILLE, Tenn.–(BUSINESS WIRE)–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 …

KNOXVILLE, Tenn.–(BUSINESS WIRE)–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.

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