Phase 3 International Trial of PV-10 for
Stage III Locally Advanced Cutaneous Melanoma
Phase 1b/2 Trial of PV-10 In Combination
with Keytruda® for Stage IV Metastatic Melanoma
Provectus Biopharmaceuticals, Inc. (NYSE MKT:PVCT,
http://www.pvct.com), a clinical-stage oncology and dermatology
biopharmaceutical company (“Provectus”), today confirmed that
patients have been dosed in both its Phase 3 clinical trial of
PV-10, Provectus’ novel investigational drug for cancer, for Stage
III locally advanced cutaneous melanoma and its Phase 1b/2 clinical
trial of PV-10 in combination with Merck’s anti-PD-1 therapy
KEYTRUDA® (pembrolizumab) in patients with Stage IV melanoma. In
addition, the Company confirmed that it continues to enroll
patients in all of its active oncology studies.
Eric Wachter, Chief Technology Officer of Provectus, said, “With
patients starting treatment in both of these studies, the clock is
ticking to interim results and ultimately the completion of these
studies. Our recruitment activities are moving ahead and we are
hopeful that these studies will play critical roles in
demonstrating effectiveness and safety of PV-10 in melanoma.”
PHASE 3 STUDY
The Phase 3 study is an international multicenter, open-label,
randomized controlled trial (RCT) of single-agent intralesional
(IL) PV-10 versus systemic chemotherapy to assess treatment of
locally advanced cutaneous melanoma in patients who are BRAF V600
wild-type and have failed or are not otherwise candidates for
ipilimumab or another immune checkpoint inhibitor. Subjects in the
PV-10 arm receive IL PV-10 to all of their melanoma lesions.
Subjects in the comparator arm receive the investigator's choice of
dacarbazine or temozolomide as determined by investigator
preference and/or local availability of the agent. Effectiveness
will be assessed by comparison of progression-free survival (PFS)
between all intent-to-treat (ITT) subjects in the two study arms.
The primary outcome measure of PFS is assessed every 12 weeks up to
18 months using RECIST 1.1 criteria. Secondary outcome measures
include complete response rate (CRR) and its duration (assessed
every 12 weeks up to 18 months); and overall survival (OS) assessed
every 12 weeks up to 18 months. Safety and tolerability will be
assessed by monitoring the frequency, duration, severity and
attribution of adverse events and evaluating changes in laboratory
values and vital signs. For more details on the study, please visit
https://www.clinicaltrials.gov/ct2/show/NCT02288897.
Currently, three sites are recruiting patients, with four
additional sites nearing opening of enrollment. Additional sites
are in process of being added in the coming weeks.
- St. Luke's Hospital and Health Network,
Easton, PA;
- Atlantic Health System, Morristown,
NJ
- University of Louisville, Louisville,
KY;
- Huntsman Cancer Institute, Salt Lake
City, UT; (not yet recruiting),
- M.D. Anderson Cancer Center, Houston,
TX; (not yet recruiting),
- Sharp Memorial Hospital, San Diego, CA;
(not yet recruiting),
- Princess Alexandra Hospital, Brisbane,
Australia; (not yet recruiting).
Dr. Wachter noted, “We are currently finalizing amendments to
the protocol that will refine the eligible patient population,
consistent with a trial to be expanded this year beyond our
historic base in the U.S. and Australia, and to afford additional
flexibility in choice of comparator to address the changing
treatment options available to patients globally.”
Phase 1b/2 Study
The Phase 1b/2 study is an international multicenter,
open-label, sequential phase study of intralesional PV-10 in
combination with systemic immune checkpoint inhibition. 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 current Phase 1b portion
of the study, all participants will 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 (i.e., PV-10 + standard of
care vs. standard of care).
Up to 24 subjects will be enrolled in the Phase 1b portion of
the study. Each subject in this cohort will receive the combination
of IL PV-10 and pembrolizumab. The expected completion date is in
2016 for the Phase 1b portion of the study.
A total of an estimated 120 subjects will be randomized in a 1:1
ratio to the two treatment arms (i.e., PV-10 + pembrolizumab or
pembrolizumab alone) in the Phase 2 portion of the study. This
number of subjects may be modified based on emerging evidence of
preliminary efficacy and effect size from the Phase 1b portion of
the study.
Subjects assigned to receive PV-10 in Phase 1b and 2 will
receive initial IL PV-10 to their injectable cutaneous and
subcutaneous lesions commencing on study Day 1 for up to 13 weeks
(i.e., the investigational treatment phase of the study). PV-10 may
be re-administered at 21-day (3-week) intervals during this period
to any remaining, uninjected cutaneous and subcutaneous lesions
until all injectable cutaneous and subcutaneous lesions have been
injected. Lesions that fail to exhibit complete ablation may be
re-injected on this schedule.
Pembrolizumab will be administered at 21-day (3-week) intervals
per prescribing information (label) commencing on study Day 1 for
up to 24 months or until disease progression, toxicity requiring
discontinuation of study treatment or study termination.
Response assessment in both phases of the study will be based on
PFS using RECIST 1.1 criteria.
Dr. Wachter added, “Current research suggests that using
anti-cancer drugs in combination can have additive or synergistic
effects that can improve the outcomes patients experience.
KEYTRUDA® and PV-10 together may prove more effective than either
agent alone in treating certain cases of melanoma. We believe that
our current Phase 3 study that tests PV-10 on its own for Stage III
patients is designed to prove its effectiveness, but we also
believe that we should examine combination therapies to maximize
potential benefit to patients, especially those with advanced
disease.”
The details of the study are available at
https://www.clinicaltrials.gov/ct2/show/NCT02557321.
For a complete history of Provectus' research into PV-10 as an
investigational treatment for melanoma, visit
https://www.pvct.com/pv10melanoma.html.
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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160112005232/en/
Provectus Biopharmaceuticals, Inc.Peter R. Culpepper,
866-594-5999 #30CFO, COOorInvestor RelationsPorter, LeVay &
Rose, Inc.Marlon Nurse, 212-564-4700DM, SVPorMedia RelationsTodd
Aydelotte, 646-428-0644
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