Provectus Biopharmaceuticals Announces PV-10 Data Discussed at 6th European Post-Chicago Melanoma/Skin Cancer Meeting
July 13 2016 - 6:00AM
Business Wire
Dr. Sanjiv Agarwala Presented PV-10 Phase 3
Study Design in Symposium on Current Clinical Trials
Provectus Biopharmaceuticals, Inc. (NYSE MKT:PVCT,
www.provectusbio.com), a clinical-stage oncology and dermatology
biopharmaceutical company ("Provectus" or the "Company”), today
announced that data on PV-10 as a treatment for melanoma was
presented June 30, 2016 at the 6th European Post-Chicago
Melanoma/Skin Cancer Meeting in Munich, Germany.
Sanjiv Agarwala, MD, Professor of Medicine at Temple University,
Chief, Oncology & Hematology at St. Luke’s Cancer Center in
Bethlehem, Pennsylvania and Global Lead Investigator for the phase
3 study of PV-10 in locally advanced cutaneous melanoma (protocol
PV-10-MM-31), participated in a symposium, “Current Clinical Trials
I.” His presentation covered the status of clinical trials of
leading oncolytic agents for the treatment of soft tissue and skin
metastases, including the ongoing phase 3 study of PV-10 and the
phase 1b study of PV-10 in combination with pembrolizumab
(Keytruda®).
During his presentation, Dr. Agarwala noted that “systemic
therapy is not always possible or appropriate” for patients with
locally advanced disease, and that “local-regional control of soft
tissue/skin metastases is clinically important.” Touching on six
different types of oncolytic therapy, he highlighted key efficacy
and safety data for PV-10 when used for direct ablation of dermal
and soft tissue metastases, and noted that PV-10 is the only one
currently being studied as both monotherapy and in the combination
setting (with pembrolizumab). With regard to combination therapy,
he noted that newer intralesional therapies like PV-10 are the
“backbone for future combinations” since they are capable of
producing a systemic anti-tumor immune response complementary to
that of immune checkpoint inhibitors.
To view his presentation, please visit http://www.pvct.com/presentation/EuropeanPostChicago-2016.
For more information about the meeting visit:
http://www.melanomaglobal2016.org/.
About Provectus Biopharmaceuticals, Inc.
Provectus Biopharmaceuticals is investigating new therapies for
the treatment of skin cancer, liver cancer and breast cancer.
Provectus’ investigational oncology drug, PV-10, is an ablative
immunotherapy under investigation in solid tumor cancers. 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160713005333/en/
Porter, LeVay & Rose, Inc.Investor RelationsMarlon Nurse,
DM, SVP, 212-564-4700orAllison + PartnersMedia RelationsTodd
Aydelotte, 646-428-0644Managing DirectororProvectus
Biopharmaceuticals, Inc.Peter R. Culpepper, Interim CEO, COO,
866-594-5999 #30
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