Provectus Biopharmaceuticals, Inc. (NYSE MKT:PVCT) (http://www.pvct.com),
a development-stage oncology and dermatology biopharmaceutical company
(“Provectus”), announced today that it has retained INC Research, a
leading, global Phase I to IV contract research organization, to conduct
an FDA due diligence audit of its regulatory documents for PH-10 and
PV-10.
The audit will be conducted in two phases, both of which are expected to
be completed by early November 2014. In the first phase, INC Research
Quality and Compliance Consulting will undertake a regulatory document
inventory and evaluation of the contents of Provectus’ information
management system (the Smart Room). The results of this phase will
generate a document request list, and the second phase of the audit will
involve further evaluation of the requested documents. This will entail
onsite verification of the regulatory documents and a final analysis of
diligence issues identified in the audit.
The audit will not touch on assessing information and relevant documents
specific to marketing applications, marketing and promotion activities,
nor will it address nonclinical and clinical data supporting final
reports.
Dr. Craig Dees, PhD, CEO of Provectus, said, "Provectus is pleased to be
working with INC Research Quality and Compliance Consulting in
conducting this audit. By retaining their services, we are endeavoring
to ensure that the upcoming phase 3 trial for PV-10 as a treatment for
melanoma as well as the future tests of both PV-10 for other indications
and for PH-10 to treat dermatological diseases proceed with all possible
speed. Making sure that all the paperwork is available and in good order
will smooth out the process.”
About INC Research
INC Research is a leading global contract research organization (CRO)
providing the full range of Phase I to Phase IV clinical development
services for the biopharmaceutical and medical device industry.
Leveraging the breadth of its service offerings and the depth of its
therapeutic expertise across multiple patient populations, INC Research
connects customers, clinical research sites and patients to accelerate
the delivery of new medicines to market. INC Research was ranked "Top
CRO to Work With" by sites worldwide in the 2013 CenterWatch Global
Investigative Site Relationship Survey. INC Research is headquartered in
Raleigh, NC, with operations across six continents and experience
spanning more than 100 countries.
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, and June 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.
Copyright Business Wire 2014