Provectus’ Intralesional PV-10 Clinical Data Published in the Annals of Surgical Oncology
October 28 2014 - 6:00AM
Business Wire
Article Now Available as an Epub Ahead of
Print
Provectus Biopharmaceuticals, Inc. (NYSE MKT:PVCT)
(http://www.pvct.com), a development-stage oncology and dermatology
biopharmaceutical company (“Provectus”), announced today that data
on its investigational new drug PV-10, obtained in clinical trial
PV-10-MM-02 (ClinicalTrials.gov Identifier NCT00521053), has been
published by the Annals of Surgical Oncology (ASO). The
peer-reviewed article, entitled “Phase 2 Study of Intralesional
PV-10 in Refractory Metastatic Melanoma”, is available as an Epub
ahead of print, and may be accessed at
http://dx.doi.org/10.1245/s10434-014-4169-5.
The Annals of Surgical Oncology is the official journal of the
Society of Surgical Oncology (SSO) and the American Society of
Breast Surgeons. Annals is published monthly by Springer.
Dr. Craig Dees, PhD, CEO of Provectus, said, "We are extremely
pleased to have the final story on our phase 2 study of PV-10 in
melanoma published in one of the leading oncology journals. With
the emphasis of our upcoming phase 3 study on patients with locally
advanced melanoma, which is a patient population frequently treated
by surgical oncologists, the ASO is the perfect journal for these
results.”
About the Annal of Surgical Oncology
The Annals of Surgical Oncology is one of the leading journals
in oncology and surgery. The official journal of the Society of
Surgical Oncology and the official journal of the American Society
of Breast Surgeons, Annals is a monthly publication that features
original articles on the latest advances in oncology for surgeons
from all specialties.
Annals benefits surgeons, oncologists, hematologists,
radiologists, general practitioners, pathologists, researchers,
academicians, and other clinical professionals interested in all
aspects of the surgical treatment of cancer. The journal is in the
top 5% of all surgery journals according to its ISI Impact
Factor.
The mission of the Annals of Surgical Oncology is to serve its
readers by 1) representing and advancing the profession of surgical
oncology throughout the nation and the world; 2) promoting the
highest quality multidisciplinary patient care and practice
management; 3) providing relevant cancer education and research
training materials using print and electronic media; 4) promoting
clinical and translational cancer research, with an emphasis on
clinical trials; 5) facilitating the career development of surgical
trainees and their transition into academic and community-based
practice; and 6) promoting public policy and patient advocacy
issues related to surgical patient with cancer.
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 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, 2013, and in our Quarterly Reports on Form 10-Q for
the quarters ended March 31, 2014, and June 30, 2014), and the
following:
• our determination, based on guidance from the FDA, whether
to proceed with or without a partner with a phase 3 trial of PV-10
to treat locally advanced cutaneous melanoma and the costs
associated with such a trial if it is necessary; • our
determination whether to license PV-10, our melanoma drug product
candidate, and other solid tumors such as liver cancer, 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 liver cancer; • 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.
Provectus Biopharmaceuticals, Inc.Peter R. Culpepper,
866-594-5999 #30CFO, COOorInvestor RelationsPorter, LeVay &
Rose, Inc.Marlon Nurse, 212-564-4700DM, SVPorMedia RelationsBill
Gordon, 212-724-6312
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