Provectus Biopharmaceuticals Announces Abstract Available on PV-10 Plus Radiotherapy in Melanoma
May 19 2016 - 4:00PM
Business Wire
Abstract Published in Conjunction with 2016
ASCO Annual Meeting
ASCO Meeting Runs June 3-7, 2016, Chicago,
Illinois
Provectus Biopharmaceuticals, Inc. (NYSE MKT:PVCT,
www.provectusbio.com), a clinical-stage oncology and dermatology
biopharmaceutical company ("Provectus" or “The Company”), today
announced the availability of an abstract titled “A phase 2 study
of intralesional PV-10 followed by radiotherapy for localized in
transit or recurrent metastatic melanoma” that has been published
in conjunction with the annual meeting of the American Society of
Clinical Oncology ("ASCO") being held in Chicago June 3-7,
2016.
To see this abstract, visit:
http://abstracts.asco.org/176/AbstView_176_167555.html
The abstract, ID: e21072, was published May 18, 2016, and is
authored by Matthew Foote and colleagues at the Princess Alexandra
Hospital and University of Queensland, in Brisbane, Australia.
Eric Wachter, Ph.D., Chief Technology Officer of Provectus,
noted, “This abstract describes initial analysis of data from an
investigator-initiated study of PV-10 followed by regional
radiotherapy for refractory melanoma. Patients received a single
course of PV-10, and if not immediately achieving a complete
response they received a modest dose of radiation 6-10 weeks later.
This combination yielded an 87% response rate with a third of
patients achieving complete response. The response was durable
(12.2 months mean duration of complete response), however, the
protocol did not allow for subsequent retreatment, and the authors
report that 80% of patients eventually had recurrence. Nonetheless,
the melanoma specific survival of almost 5 and a half years is
encouraging, and I agree with the authors’ conclusion that these
results justify expanded evaluation in a randomized trial.”
Wachter continued, “This work arose from observations by these
same researchers several years ago that, as they stated at the
time, melanoma patients treated with PV-10 followed by external
beam radiotherapy ‘had an impressive response.’ Also as observed in
those early cases, the data reported in this ASCO abstract show
that there appears to be minimal potential for increased side
effects when PV-10 is used in combination with radiotherapy.”
Wachter concluded, “The primary purpose of presenting research
data at international meetings such as ASCO is to share knowledge
within the medical community. An important implication of this is
fostering dialog within the community regarding appropriate use of
such data. In this case, I hope this initial report will help
foster relationships that facilitate advancement of these findings
into advanced studies, as suggested by the authors.”
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/20160519006525/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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