Study could be a “Significant Step to
Co-Development Transaction”
Provectus Biopharmaceuticals, Inc. (NYSE MKT:PVCT,
http://www.pvct.com), a development-stage oncology and dermatology
biopharmaceutical company (“Provectus” or the “Company”), today
announced it has completed development of the protocol for
Phase1b/2 testing of its investigational cancer drug PV-10 in
combination with pembrolizumab in patients with Stage IV melanoma.
Pembrolizumab (also known as Keytruda®, a product of Merck and Co.
Inc., NYSE: MRK) is an immune checkpoint inhibitor approved for
treatment of patients with advanced or unresectable melanoma. PV-10
is Provectus’s novel investigational drug for cancer that is
injected into solid tumors (intralesional administration); it is
currently undergoing Phase 3 clinical testing in patients with
Stage III melanoma. Clinical testing under the new Phase 1b/2
protocol is expected to commence before the end of the year.
The combination protocol enables initial clinical testing of
concepts at the center of a patent held by Provectus, U.S. Patent
number 9,107,887, which Pfizer, Inc. (NYSE: PFE) jointly owns.
Specifically, the patent covers the use of PV-10 in combination
with systemic inhibitors of immune system down-regulation, such as
anti-CTLA-4, PD-1 and PD-L1 immune checkpoint inhibiting
antibodies. Pembrolizumab is an anti-PD-1 antibody. Pre-clinical
testing of PV-10 used in combination with these important classes
of drugs demonstrated potential importance for treatment of
advanced cancers.
The FDA granted accelerated approval to pembrolizumab in
September 2014, making it the first FDA-approved anti-PD-1 immune
checkpoint inhibitor. Because pembrolizumab is already
FDA-approved, Provectus can commence this study with or without
assistance of a partner.
The Phase 1b/2 study will incorporate a modest sized single arm
Phase 1b component of 24 subjects with expedited safety and
efficacy end points. This is designed to support expansion to a
larger randomized Phase 2 component. Combined, these two arms will
enable assessment of the potential safety and clinical benefit of
PV-10 when used with pembrolizumab for treatment of advanced
melanoma.
Dr. Eric Wachter, CTO of Provectus, stated, “The primary end
point of tolerability in the Phase 1b portion of the study,
combined with assessment of progression free survival (PFS) and
objective response rate (ORR) by RECIST criteria as key secondary
endpoints, assessed over a 15 week treatment interval, establish a
basis for determining whether to proceed to the larger, randomized
Phase 2 portion of the study. We will use an adaptive design for
powering Phase 2 based on preliminary results from Phase 1, and
estimate this portion of the study to require at least 120
subjects, with a primary endpoint of PFS and key secondary endpoint
of ORR. In both portions of the study, pembrolizumab will be
administered every three weeks for up to 24 months, as is standard
of care; PV-10 will be administered on the same schedule for the
first 15 weeks to all of the subject’s skin lesions. Subjects in
Phase 1b will receive both PV-10 and pembrolizumab, whereas in
Phase 2 subjects will be randomized to PV-10 + pembrolizumab or
pembrolizumab alone.”
Pete Culpepper, CFO and COO of Provectus, noted, ”This study is
both scientifically and commercially important to Provectus.
Scientifically, combination therapy in cancer treatment is a
rapidly maturing area, where rational combination of agents is
replacing the empirical approaches of the past. Commercially, this
is the second of three steps that we hope will significantly
strengthen our hand in negotiating a co-development transaction
with an immunotherapy-focused partner. Our joint patent with Pfizer
was the first; this study is the second; and the third is our
immune mechanism of action clinical study, which is underway at the
Moffitt Cancer Center and which has completed recruitment.”
The mechanism of action study’s preliminary clinical findings,
reported last year, showed that the immunologic effects of tumor
ablation with PV-10 may be complementary to immune checkpoint
inhibition. Companion pre-clinical testing of PV-10 in murine
models of melanoma, also reported last year, showed that the
therapeutic effects of PV-10 and immune checkpoint inhibition are
increased when the two are used in combination.
The cost of pembrolizumab is reimbursed so it is not paid for by
Provectus and the remaining cost of this study is budgeted with
existing cash on hand of the Company.
For further details on the protocol visit
https://www.clinicaltrials.gov/ct2/show/NCT02557321
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, 2014) 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, 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20150923005720/en/
Provectus Biopharmaceuticals, Inc.Peter R. Culpepper, CFO,
COO866-594-5999 #30orPorter, LeVay & Rose, Inc.Marlon Nurse,
DM, SVP – Investor Relations212-564-4700orTodd Aydelotte – Media
Relations646-428-0644
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