Provectus Biopharmaceuticals’ Phase 1 PV-10 Data on Liver Cancer Presented at 6th Asia-Pacific Primary Liver Cancer Expert ...
July 06 2015 - 8:00AM
Business Wire
Preliminary Evidence of Efficacy in
Treatment of Liver Tumors with PV-10 Observed
Provectus Biopharmaceuticals, Inc. (NYSE MKT:PVCT,
http://www.pvct.com), a clinical-stage oncology and dermatology
biopharmaceutical company (“Provectus” or the “Company”), announced
today that data from its phase 1 study of PV-10 for chemoablation
of hepatocellular carcinoma (HCC) and cancer metastatic to the
liver was presented on July 3, 2015 at the 6th Asia-Pacific
Primary Liver Cancer Expert Meeting (APPLE 2015) in Osaka,
Japan.
The presenter was Dr. Sanjiv Agarwala, chief of medical oncology
and hematology at St. Luke’s Cancer Center in Bethlehem,
Pennsylvania, and professor of medicine at Temple University School
of Medicine in Philadelphia, Pennsylvania. He serves as a principal
investigator of the phase 1 clinical trial that produced the data
presented, and is the lead investigator for the phase 3 clinical
trial of PV-10 as an investigational treatment for melanoma which
recently began. The poster presentation was titled “Phase 1 Study
of PV-10 for Chemoablation of Hepatocellular Cancer and Cancer
Metastatic to the Liver.”
Based on the data presented, the researchers concluded that
preliminary efficacy in treatment of liver tumors with PV-10, a 10%
solution of rose Bengal, 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.
Provectus previously reported data on clinical and nonclinical
testing of intralesional PV-10 as an investigational treatment for
metastatic melanoma, where it has demonstrated high rates of
complete response and durable local control in injected melanoma
lesions. The phase 1 study reported at APPLE 2015 was designed to
assess safety, pharmacokinetics and preliminary efficacy of PV-10
in subjects with non-resectable HCC or cancer metastatic to the
liver.
In the phase 1 study, subjects having a target lesion in the
liver at least 1 cm in diameter were administered a single
percutaneous intralesional 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 interval. 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.
The poster is now available online at:
http://www.pvct.com/publications/APPLE-2015-PV-10-LC-01.pdf.
About APPLE 2015
APPLE 2015 is designed to promote exchanges of international and
regional expertise in the study and management of liver cancer. We
are very privileged to have a number of distinguished international
and local guest faculties who are prominent, world-class leaders in
this field, and have traveled a long way to share and discuss with
us the advances and challenges currently faced in the area of liver
cancer. For additional information about APPLE 2015, please visit
http://www2.convention.co.jp/apple2015/greeting/index.html.
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/20150706005351/en/
Provectus Biopharmaceuticals, Inc.Peter R. Culpepper, CFO,
COOPhone: 866-594-5999 #30orPorter, LeVay & Rose, Inc.Marlon
Nurse, DM, SVP – Investor Relations212-564-4700orTodd Aydelotte –
Media Relations646-428-0644
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