Protocol Amended to Reflect Current and Evolving Standard of Care and
Applicable Patient Population
Provectus Biopharmaceuticals, Inc. (NYSE MKT:PVCT, www.pvct.com),
a clinical-stage oncology and dermatology biopharmaceutical company
("Provectus" or “The Company”), today announced that the protocol for
its phase 3 clinical trial for PV-10 as an investigational treatment for
melanoma has been amended to reflect current and evolving standards of
care and applicable patient population for a global study in melanoma.
Major amendments to the protocol include the addition of talimogene
laherparepvec (ImlygicTM) as an option for use as comparator.
The amended protocol also extends eligibility to include Stage IV M1a
patients having no active nodal or distant cutaneous or subcutaneous
metastatic disease. These patients have disease characteristics and
prognosis similar to that of the Stage IIIB and IIIC patients that
initially defined the study patient population.
In addition, the updated protocol clarifies eligibility for patients not
having access to immune checkpoint inhibitors due to standard of care
and those not having access to targeted therapy due to standard of care,
as well as inclusion of patients who have failed targeted therapy. In
the latter case, patients who have failed targeted therapy but meet
study eligibility criteria have similar disease manifestations to the
remaining study population but have limited treatment options.
Dr. Eric Wachter, CTO of Provectus, said, “These kinds of amendments are
commonplace in phase 3 studies and serve to fine-tune the patient
population and study procedures to match changing care standards for a
large global study. They are the direct result of current and emerging
options for these patients and have been developed with extensive input
from global leading melanoma investigators. In particular, the most
obvious amendment addresses approval in late October of Imlygic by the
FDA as the first and only oncolytic viral therapy. As we implement the
amended protocol we will assess potential impact on study timelines.”
For further information about the study, please visit https://clinicaltrials.gov/ct2/show/NCT02288897.
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, 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.
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