Provectus Biopharmaceuticals Announces Poster Presentation on PV-10 at Annual Meeting of American Society of Clinical Oncolog...
June 09 2016 - 6:00AM
Business Wire
Poster Details PV-10 as Melanoma Treatment
as Single Agent Therapy and in Combination
Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT,
www.provectusbio.com), a clinical-stage oncology and dermatology
biopharmaceutical company ("Provectus" or “The Company”), today
announced that the poster presented at the Annual Meeting of the
American Society of Clinical Oncology is now available online.
Titled "Intralesional rose bengal for treatment of melanoma,"
the poster (abstract TPS9600) was presented Saturday, June 4, 2016,
by Dr. Sanjiv Agarwala, and can now be viewed at:
http://meetinglibrary.asco.org/content/127229?media=vm
Dr. Agarwala’s presentation reviewed the current studies
underway for melanoma utilizing PV-10: the phase 3 clinical trial
of intralesional PV-10 as a single agent therapy for locally
advanced cutaneous melanoma (study PV-10-MM-31, clinicaltrials.gov
identifier NCT02288897); and the phase 1b/2, study of intralesional
PV-10 in combination with immune checkpoint inhibition (study
PV-10-MM-1201, NCT02557321).
Study PV-10-MM-31 is an international multicenter, open-label,
randomized controlled trial (RCT) of single-agent intralesional
PV-10 versus systemic chemotherapy or intralesional oncolytic viral
therapy to assess treatment of locally advanced cutaneous melanoma.
A total of 225 patients with Stage IIIB to IV-M1a melanoma will be
randomized in a 2:1 ratio against the comparator therapy for
assessment of progression free survival.
Study PV-10-MM-1201 is an international multicenter, open-label,
sequential phase study of intralesional PV-10 in combination with
pembrolizumab, marketed by Merck as Keytruda®. Stage IV metastatic
melanoma patients with at least one injectable cutaneous or
subcutaneous lesion who are candidates for pembrolizumab are
eligible for study participation. In the Phase 1b portion of the
study, all participants receive the combination of IL PV-10 and
pembrolizumab (i.e., PV-10 + standard of care). In the subsequent
Phase 2 portion of the study participants will be randomized 1:1 to
receive either the combination of IL PV-10 and pembrolizumab or
pembrolizumab alone for assessment of progression free
survival.
Dr. Eric Wachter, Ph.D., Chief Technology Officer of Provectus,
noted, “ASCO is the largest and most important oncology meeting of
the year, and we were extremely fortunate to be selected for
participation in the technical program. This international meeting
allows us to have face-to-face discussions with current and
prospective investigators from around the globe where we can
efficiently exchange information about our development efforts,
changes in the oncology landscape, and potential impacts on
protocol designs.”
Dr. Wachter continued, “This meeting occurred at a fortuitous
time, since we have had numerous discussions with key investigators
over the several months since our phase 3 protocol underwent
significant updating earlier this year to address changes in
standard of care for patients with locally advanced cutaneous
melanoma. These discussions identified several small but important
changes to patient eligibility to align protocol requirements more
closely with typical patient characteristics, and we intend to
implement these in the near future, particularly in light of the
positive feedback we received to these at the meeting.”
About ASCO
ASCO promotes and provides for lifelong learning for oncology
professionals; cancer research; an improved environment for
oncology practice; access to quality cancer care; a global network
of oncology expertise; and educated and informed patients with
cancer. ASCO is supported by its affiliate organization, the
Conquer Cancer Foundation, which funds groundbreaking research and
programs that make a tangible difference in the lives of people
with cancer. For further information, visit
http://www.asco.org/.
About Provectus Biopharmaceuticals, Inc.
Provectus Biopharmaceuticals, Inc., specializes in developing
oncology and dermatology therapies. PV-10 is a novel
investigational drug for cancer: 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.provectusbio.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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version on businesswire.com: http://www.businesswire.com/news/home/20160609005212/en/
Provectus Biopharmaceuticals, Inc.Peter R. Culpepper, Interim
CEO, COOPhone: 866-594-5999 #30orPorter, LeVay & Rose,
Inc.Marlon Nurse, DM, SVP – Investor RelationsPhone:
212-564-4700orAllison + PartnersTodd Aydelotte, Managing Director –
Media RelationsPhone: 646-428-0644
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