Provectus Biopharmaceuticals Announces Publication of Article on PV-10 for In-Transit Melanoma in Journal of Surgical Oncology
June 07 2016 - 4:00PM
Business Wire
“Intralesional PV-10 for In-Transit Melanoma
- A Single Centre Experience”
Provectus Biopharmaceuticals, Inc. (NYSE MKT:PVCT,
www.provectusbio.com), a clinical-stage oncology and dermatology
biopharmaceutical company ("Provectus" or “The Company”), today
announced that an article on the use of PV-10 for in-transit
melanoma has been published by the Journal of Surgical Oncology. It
expands on a presentation on the same topic given at the Royal
Australasian College of Surgeons 85th Annual Scientific Congress,
which was held 2-6 May 2016, in Brisbane, Australia.
Titled "Intralesional PV-10 for In-Transit Melanoma - A Single
Centre Experience," the article reports on use of PV-10 in the
management of in-transit melanoma at the Peter MacCallum Cancer
Centre, in East Melbourne, Victoria, Australia. The article was
authored by Jocelyn Lippey et al. using retrospective analysis of
data from nineteen patients receiving PV-10 at the center between
2010 and 2014.
Dr. Lippey reported, “After a median follow up of 11.7 months,
disease control was achieved in 63% of patients. Five patients
(26%) achieved a complete response, another five (26%) patients
achieved a partial response, and two patients had stable disease
(11%) at the time of last follow-up. Seventy-four percent (14/19)
of patients had a clinical response at time of first follow-up
(median time 21 days); range 8–91 days. Younger patients and those
with smaller lesions were more likely to respond to treatment.” The
median age of patients in this series was 80 years.
Dr. Lippey also noted, “Ten patients did not have all lesions
injected, primarily due to the number of lesions present. A
bystander response was noted in un-injected lesions in 50% of
patients who did not have all their lesions directly injected.”
Eric Wachter, CTO of Provectus commented, “The results reported
here are consistent with other evaluations of PV-10 in melanoma,
and highlight both the rapid ablative properties and the
immunologic features of PV-10 as an investigational ablative
immunotherapy.”
The article can be found at
http://onlinelibrary.wiley.com/doi/10.1002/jso.24311/pdf
About the Peter MacCallum Cancer Centre
Peter MacCallum Cancer Centre is Australia's only public
hospital solely dedicated to cancer treatment, research and
education. The hospital treats more cancer patients each year than
any other hospital and the highly skilled medical, nursing and
allied health team is backed by the largest cancer research group
in Australia. Peter Mac has five locations across the state and
provides services to patients from across Victoria and Australia
and overseas. Multi-disciplinary teams, consisting of medical,
surgical and radiation oncologists, nurses, radiation therapists
and allied health professionals, develop comprehensive and
coordinated treatment plans, ensuring patients get treatment and a
team tailored to their individual needs. For more information,
visit http://www.petermac.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/20160607006656/en/
Provectus Biopharmaceuticals, Inc.Peter R. Culpepper,
866-594-5999 #30Interim CEO, COOorPorter, LeVay & Rose,
Inc.Marlon Nurse, 212-564-4700DM, SVP – Investor RelationsorAllison
+ PartnersTodd Aydelotte, 646-428-0644Managing Director – Media
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