KNOXVILLE, Tenn. -- (Business Wire)
Provectus Biopharmaceuticals, Inc. (NYSE MKT:PVCT, http://www.pvct.com),
a development-stage oncology and dermatology biopharmaceutical company
(“Provectus”), announced today that it will be meeting with the U.S.
Food and Drug Administration (the “FDA”) to review certain operational
aspects of the protocol for its planned phase 3 clinical trial of
intralesional PV-10, its novel investigational drug for cancer, as a
treatment for melanoma. No date for this meeting has been agreed upon as
yet.
Eric Wachter, PhD, CTO of Provectus, stated, “When we submitted the
protocol to the Agency in November, we included a brief list of
questions about certain operational aspects of the protocol, in
particular regarding eligibility requirements relevant to maximizing the
speed of enrollment of patients in the study. This is standard practice
for a pivotal submission. The FDA has subsequently indicated that a
formal meeting is appropriate to assure that these questions are
addressed in a timely and documented manner. We hope the meeting will
occur in January or early February 2015.”
Dr. Wachter added, “We currently have eight sites, four in the U.S. and
four in Australia, in our expanded access program that are using PV-10
for melanoma and other cutaneous malignancies. They will provide a path
to quickly starting enrollment once this review period is finished. In
addition, we expect additional sites to join the study pending action by
their respective Institutional Review Boards.”
Dr. Wachter concluded, “I want to stress that this meeting with the
Agency in no way affects the fundamental design of the study, and the
FDA has given us no indication that it has any concerns about the
proposed study design and endpoints.”
For a detailed list of the current inclusion and exclusion criteria and
further details regarding the endpoints of the study, visit: https://clinicaltrials.gov/ct2/show/NCT02288897?term=pv-10&rank=5
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, 2013, and in our Quarterly
Reports on Form 10-Q for the quarters ended March 31, 2014, June 30,
2014, and September 30, 2014), and the following:
-
our determination, based on guidance from the FDA, whether to proceed
with or without a partner with a phase 3 trial of PV-10 to treat
locally advanced cutaneous melanoma and the costs associated with such
a trial if it is necessary;
-
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.
Contacts:
Provectus Biopharmaceuticals, Inc.
Peter R. Culpepper, CFO, COO,
866-594-5999 #30
or
Porter, LeVay & Rose, Inc.
Investor
Relations
Marlon Nurse, DM, SVP, 212-564-4700
or
Media
Relations
Bill Gordon, 212-724-6312
Source: Provectus Biopharmaceuticals, Inc.
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