PV-10 Enhanced Tumor-Specific Immunity with
Co-Inhibitory Blockade
Highlights Potential Additional Path for
Development of PV-10 for Cancer
Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT,
http://www.pvct.com), a development-stage oncology and dermatology
biopharmaceutical company ("Provectus"), announced today that data
on its investigational agent PV-10 for intralesional (IL) treatment
of cancer was featured in a poster presentation at the Society for
Immunotherapy of Cancer [SITC] 29th Annual Meeting on Saturday,
November 8, 2014. The presentation, titled "Efficacy of
Intralesional Injection with PV-10 in Combination with
Co-Inhibitory Blockade in a Murine Model of Melanoma," is available
at http://www.pvct.com/publications/SITCposter2014.pdf.
The poster, presented by Dr Shari Pilon-Thomas of the Moffitt
Cancer Center, concludes that the new data "support combination
therapy with IL PV-10 and co-inhibitory blockade."
In clinical trials, IL PV-10 has induced regression of both
injected lesions and uninjected bystander lesions in patients with
melanoma, and tumor ablation with PV-10 has been shown to increase
certain T-cell populations in patients’ peripheral blood. In the
study reported at SITC, the team from Moffitt measured whether IL
PV-10 and co-inhibitory blockade could improve anti-tumor immunity
and regression of melanoma in mice.
The testing assessed response of injected and uninjected B16
melanoma tumors in mice receiving PV-10 alone or in combination
with one of three agents designed for co-inhibitory blockade. The
tested agents targeted either CLTA-4, PD-1 or PD-L1, the three most
common clinical targets for co-inhibitory blockade. In each case,
combination of PV-10 with co-inhibitory blockade led to improved
tumor response and enhanced anti-tumor immunity of T-cells. Further
testing with the anti-PD-L1 agent showed that these improvements
could apply to both injected and uninjected tumors.
Eric Wachter, PhD and Chief Technology Officer of Provectus,
said, "This important work further validates use of an
intralesional therapy with a systemic immunotherapy, and solidifies
our plans for a promising second path for development of PV-10. In
addition to use as a single-agent therapy for cutaneous melanoma
(the focus of our phase 3 study), these findings support
commencement of clinical testing of PV-10 in combination
anti-CLTA-4, anti-PD-1 or anti-PD-L1 agents. We are assessing
strategies to allow this work to commence in a timely and
cost-effective manner so that we can begin translating these model
test results into human clinical data.”
About The Society for Immunotherapy of Cancer (SITC)
The Society for Immunotherapy of Cancer (SITC) is a 501 (c)(3)
non-profit society of medical professionals. Recent advances in
immunology and biology have opened up new horizons in the field of
cancer therapy, with an upsurge in the integration of new biologic
agents into clinical practice. With several high-caliber scientific
meetings with a focus on clinical and translational aspects of
biologic approaches to cancer treatment and numerous networking
opportunities unique to this organization, the Society for
Immunotherapy of Cancer (SITC) has developed into the premier
destination for interaction and innovation in the cancer immunology
and immunotherapy community. The goals of SITC are directed towards
the rapid dissemination of information in these areas to expedite
the safe transfer of both basic and applied research to the
clinical setting.
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, 2013, and in our Quarterly Reports on Form 10-Q for
the quarters ended March 31, 2014, June 30, 2014, and September 30,
2014), and the following:
• our determination, based on guidance from the FDA, whether
to proceed with or without a partner with a phase 3 trial of PV-10
to treat locally advanced cutaneous melanoma and the costs
associated with such a trial if it is necessary; • our
determination whether to license PV-10, our melanoma drug product
candidate, and other solid tumors such as liver cancer, 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 liver cancer; • our ability
to license our dermatology drug product candidate, 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.
Provectus Biopharmaceuticals, Inc.Peter R. Culpepper, CFO,
COO866-594-5999 #30orPorter, LeVay & Rose, Inc.Marlon Nurse,
DM, SVP – Investor Relations212-564-4700orBill Gordon – Media
Relations212-724-6312
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