Provectus Biopharmaceuticals Met with FDA on Operational Aspects of PV-10 Phase 3 Melanoma Study
February 09 2015 - 6:00AM
Business Wire
FDA allows Provectus to go forward on Phase
3
Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT,
www.pvct.com), a development-stage oncology and dermatology
biopharmaceutical company (“Provectus”), announced today that it
has held a Type C meeting with the U.S. Food and Drug
Administration (the “FDA” or the “Agency”) 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. The meeting was held
by teleconference on January 29, 2015.
Eric Wachter, PhD, CTO of Provectus, stated, “As noted in our
press release of December 22, 2014, when we submitted the protocol
to the Agency in November 2014, we included a brief list of
questions about certain operational aspects of the protocol. The
FDA subsequently indicated that a formal meeting was appropriate to
assure that these questions were addressed in a timely and
comprehensive manner. As is typical for such meetings, we provided
a more extensive list of questions in the formal meeting package.
This led to a very thorough and helpful review of the protocol as a
result of the meeting.”
Topics formally reviewed included subject eligibility
requirements, primary and secondary study end points, and study
lesion definitions and conventions for defining disease
progression.
Dr. Wachter noted, “We are extremely grateful for the careful
review conducted by the Agency. The outcome of the review does not
affect the fundamental design of the study nor the patient
population, but does affect certain details concerning some
secondary end points and statistical analysis matters, such as the
treatment of missing data. We are making a number of small changes
to the protocol in light of this review, and will issue a final
version later this month.”
Dr. Wachter added, “We have eight sites, four in the U.S. and
four in Australia, in our expanded access program currently using
PV-10 for melanoma and other cutaneous malignancies. We expect that
they will provide a path to quickly starting enrollment upon
completion of the review period. In addition, we have been
qualifying additional sites that will join the study pending action
by their respective Institutional Review Boards.”
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.
Provectus Biopharmaceuticals, Inc.Peter R. Culpepper,
866-594-5999 #30CFO, COOorPorter, LeVay & Rose, Inc.Investor
RelationsMarlon Nurse, 212-564-4700DM, SVPorMedia RelationsBill
Gordon, 212-724-6312
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