Provectus Biopharmaceuticals Awarded US Patent Protecting Use of PV-10 as Part of Combination Therapy for Cancer
18 August 2015 - 11:25PM
Business Wire
Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT,
http://www.pvct.com), a clinical-stage oncology and dermatology
biopharmaceutical company (“Provectus” or the “Company”) today
announced that it has received a patent from the US Patent and
Trademark Office, U.S. Patent number 9,107,887. The patent protects
the use of PV-10 in combination with certain other types of drugs
in the treatment of melanoma and cancers of the liver.
Specifically, the patent covers the use of PV-10 in combination
with systemic inhibitors of immune system down-regulation, such as
anti-CTLA-4, PD-1 and PD-L1 antibodies, along with enhancers of
immune system up-regulation, such as IL-2 and interferon-gamma.
Pre-clinical testing of PV-10 used in combination with these
important classes of drugs demonstrated potential importance for
treatment of advanced cancers.
Provectus believes that the intellectual property covered by the
patent will aid it in realizing financial rewards if clinical
research demonstrates that PV-10 used in combination with one or
more of these classes of drugs improves patient outcomes.
Dr. Eric Wachter, CTO of Provectus, said, “This is a significant
milestone in the development of PV-10 as an anti-cancer agent, and
builds on our research into PV-10 used on its own. Medical science
and our own preliminary studies suggest that it may benefit
patients when used in conjunction with these other drugs.”
Peter Culpepper, CFO and COO of Provectus, noted, as just one
example, a poster presentation at the Society for Immunotherapy of
Cancer [SITC] 29th Annual Meeting in November 2014. The poster,
presented by Dr. Shari Pilon-Thomas of the Moffitt Cancer Center,
titled "Efficacy of Intralesional Injection with PV-10 in
Combination with Co-Inhibitory Blockade in a Murine Model of
Melanoma,” showed that combination of PV-10 with anti-CTLA-4, PD-1
and PD-L1 antibodies led to improved tumor response and enhanced
anti-tumor immunity of T-cells.
Pfizer Inc. is a joint owner of the patent.
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, including its current phase 3 study in melanoma,
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 melanoma drug product candidate, 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 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20150818005877/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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