Provectus Biopharmaceuticals’ Data on PV-10 for Chemoablation of Liver Cancers Presented at ESMO 17th World Congress on Gas...
July 02 2015 - 6:00AM
Business Wire
Preliminary Evidence of Efficacy
Observed
Provectus Biopharmaceuticals, Inc. (NYSE MKT:
PVCT,www.pvct.com), a clinical-stage oncology and dermatology
biopharmaceutical company ("Provectus" or the "Company"), announced
that data from its phase 1 study of PV-10 for chemoablation of
hepatocellular carcinoma (HCC) and cancer metastatic to the liver
was presented at the ESMO 17th World Congress on Gastrointestinal
Cancer (ESMO-GI). The main conclusion was that preliminary evidence
of efficacy in treatment of liver cancers with PV-10 was observed.
The poster presentation was made by Eric Wachter, Ph.D., Chief
Technology Officer of Provectus.
Provectus has previously reported data on clinical and
nonclinical testing of intralesional PV-10, a 10% solution of rose
bengal, as an investigational treatment for metastatic melanoma,
where it has demonstrated high rates of complete response and
durable local control in melanoma lesions. The current phase 1
study reported at ESMO-GI was designed to assess safety,
pharmacokinetics, and preliminary efficacy of PV-10 in subjects
with non-resectable HCC or other types of cancer metastatic to the
liver.
In the phase 1 liver study, subjects having a target lesion in
the liver at least 1 cm in diameter were administered a single
percutaneous injection of PV-10 into their target lesion. Plasma
concentrations of PV-10 from 1 hour to 28 days after injection were
measured. Radiologic assessments of the injected target lesion were
performed to determine response over an initial 28-day and longer
term 9-15 month follow-up period. Serum levels of potential liver
injury markers were measured, and adverse events recorded.
In the initial study cohort, six subjects received PV-10
injections in two successive escalating dose cohorts of 0.25 and
0.50 mL per cm3 lesion volume. Significant adverse events were
limited to injection site and photosensitivity reactions that
resolved without sequelae. All injected tumors were stable in size
at 28 days, and among four of the initial six tumors that had
longer-term assessment, two had partial response.
Based on these data, the researchers concluded that preliminary
efficacy in treatment of liver tumors with PV-10 was observed with
acceptable tolerability. The study is continuing at three study
centers with two expansion cohorts to further assess safety and
response in HCC and other cancers metastatic to the liver.
The poster is now available online at:
http://www.pvct.com/publications/ESMO-2015-PV-10-LC-01.pdf.
About ESMO 17th World Congress on
Gastrointestinal Cancer
The ESMO 17th World Congress on Gastrointestinal Cancer is the
premier global event in the field, encompassing malignancies
affecting every component of the gastrointestinal tract and aspects
related to the care of patients with gastrointestinal cancer,
including screening, diagnosis and the latest management options
for common and uncommon tumors. For additional information about
the ESMO 17th World Congress, please visit
http://worldgicancer.com/WCGI/WGIC2015/index.asp.
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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20150702005061/en/
Provectus Biopharmaceuticals, Inc.Peter R. Culpepper, CFO,
COOPhone: 866-594-5999 #30orPorter, LeVay & Rose, Inc.Marlon
Nurse, DM, SVP – Investor RelationsPhone: 212-564-4700orTodd
Aydelotte– Media RelationsPhone: 646-428-0644
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