12-Patient Study to be Conducted at The Queen Elizabeth Hospital,
Woodville, South Australia
Provectus Biopharmaceuticals, Inc. (NYSE MKT:PVCT, www.pvct.com),
a clinical-stage oncology and dermatology biopharmaceutical company
("Provectus" or “The Company”), today announced that it is initiating a
protocol titled, “A Phase 1 Study to Assess the Safety, Tolerability and
Effectiveness of PV-10 Chemoablation of Neuroendocrine Tumours (NET)
Metastatic to the Liver in the Reduction of Biochemical Markers and
Symptoms Caused by Secretory Products.”
The 12-patient phase 1 study will run up to 48 months with interim data
anticipated at the half-way point of the two-cohort study. Patients in
the first of the two successive cohorts will receive PV-10 to a single
NET tumor in their liver, while patients in the second cohort may
receive PV-10 to multiple NET tumors.
Timothy Price, M.D. will serve as principal investigator for the study
at The Queen Elizabeth Hospital in Woodville, South Australia.
Dr. Price explained, “The primary endpoint of our study will be
assessment of safety and tolerability of PV-10 in the treatment of these
metastatic NETs. Our secondary endpoints address preliminary efficacy,
disease symptoms and biomarkers, and include assessments of Objective
Response Rate (ORR) of injected and uninjected tumors; change in tumor
biomarkers (somatostatin receptor expression, chromogranin A and
5-hydroxyindole acetic acid); change in NET symptoms assessed by
standard quality of life instruments; and possible change in peripheral
blood mononuclear cells (PBMCs).”
Dr. Eric Wachter, CTO of Provectus, noted, “This protocol is a natural
complement to work ongoing in our initial study of hepatic cancers under
protocol PV-10-LC-01, which has allowed us to assess PV-10 in a number
of tumor types using the method of administration that will be used in
this new study. In addition to providing further data on the overall
safety of this approach, this study is tailored to NET patients and will
allow us to assess potential clinical benefit in terms of objective
response and changes in biomarkers and symptoms of these tumors.
Patients with metastatic NET tumors are often plagued by persistent
diarrhea, flushing, breathing difficulties, abdominal cramping and
swelling of the arms and legs. It will be very useful to determine
whether PV-10 ablates NET tumors and if ablation has a positive impact
on quality of life for patients.”
For further information, please visit https://www.clinicaltrials.gov/ct2/show/NCT02693067.
The study is expected to open for enrollment in March 2016.
About the Queen Elizabeth Hospital
The Queen Elizabeth Hospital (TQEH) is a 311 bed, acute care teaching
hospital that provides inpatient, outpatient, emergency and mental
health services to a population of more than 250,000 people living
primarily in Adelaide’s western suburbs.
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/20160229005559/en/
Copyright Business Wire 2016