Provectus Biopharmaceuticals Opens Patient Enrollment; Begins Phase 3 International FDA Comparative Clinical Trial of PV-10 f...
April 15 2015 - 04:11PM
Business Wire
Interim Data Expected When 50% of Events
Achieved
Provectus Biopharmaceuticals, Inc. (NYSE MKT:PVCT,
http://www.pvct.com), a clinical-stage oncology and dermatology
biopharmaceutical company (“Provectus” or the “Company”), enters
phase 3 and has opened enrollment of patients for its phase 3
international FDA comparative clinical trial of PV-10 for melanoma.
The Company is seeking 225 patients and enrollment has begun at St.
Luke's University Hospital and Health Network, Bethlehem,
PA, the first study site to be opened, with additional sites
to be added in the coming weeks and months.
The study is an international multicenter, open-label,
randomized controlled trial (RCT) of single-agent intralesional
PV-10 versus systemic chemotherapy with dacarbazine (DTIC) or
temozolomide (TMZ) 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 comparator arm will
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 treatment arms. The Primary Outcome
Measure is progression-free survival (PFS) to be assessed every 12
weeks up to 18 months.
The Secondary Outcome Measures include complete response rate
(CRR) and its duration (to be assessed every 12 weeks up to 18
months); and Overall survival (OS) to be 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
Top-line results from the phase 2 trial have been posted on
clinicaltrials.gov, for the study entitled "Phase 2 study of
Intralesional PV-10 for Metastatic Melanoma," [NCT00521053].
https://clinicaltrials.gov/ct2/show/NCT00521053.
For a complete history of Provectus’ research into PV-10 as a
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 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, CFO,
COO866-594-5999 #30orPorter, LeVay & Rose, Inc.Marlon Nurse,
DM, SVP – Investor Relations212-564-4700Bill Gordon – Media
Relations212-724-6312
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