Provectus Biopharmaceuticals Announces Poster Presentation on PV-10 at European Society of Medical Oncology 2016 Congress Now...
October 11 2016 - 6:00AM
Business Wire
Poster Updates Details of Studies of PV-10
as Single Agent Therapy and in Combination for Melanoma
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 European Society of
Medical Oncology 2016 Congress is now available online.
Titled "Intralesional Rose Bengal for Stage III and IV
Melanoma," the poster (abstract 1159TIP) was presented Sunday,
October 9, 2016, by Dr. Sanjiv Agarwala, and can now be viewed at:
http://provectusbio.com/media/docs/publications/ESMO%202016%20-%20Abstract%201158TIP%20-%20150%20DPI%20-%2009%20Oct%202016.pdf.
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, EudraCT no. 2016-000317-78); 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, "The annual ESMO congress has grown to be one of the largest
and most important oncology meetings of the year, and we were
privileged with selection for participation in the technical
program. Participation in this international forum allowed us to
meet face-to-face with current and prospective investigators from
around the globe, thereby providing an efficient way to exchange
information about our development plans, the potential impact of
ongoing changes in the oncology landscape, and ways to address
these impacts through refinement of protocol designs."
Dr. Wachter continued, "As we’ve reported previously, we
maintain ongoing discussions with key advisors on ways to optimize
our development plans, including ways that study designs can be
adjusted for maximum efficiency. After a major update of our key
phase 3 protocol early this year, and a smaller update at mid-year,
our ESMO participation allowed us to test the outcome of subsequent
discussions regarding further small adjustments on a broader
audience in the melanoma community. We expect to implement at least
several of these changes in the near future based on these
discussions. In particular, allowing patients with primarily or
exclusively subcutaneous melanoma (that is, melanoma below the skin
surface) and those with larger tumors should not significantly
affect the biological basis for our phase 3 study, but could
substantially expand the fraction of patients with locally advanced
disease that can participate in the study.”
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;
- 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;
and
- our ability to raise capital through
our proposed rights offering.
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version on businesswire.com: http://www.businesswire.com/news/home/20161011005326/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
Relations
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