Provectus Biopharmaceuticals Updates Market on Business Developments
March 12 2015 - 8:21AM
Business Wire
Amended Phase 3 Protocol Submitted to
FDA
Enrollment Begun in PH-10 Mechanism of
Action Study
Enrollment Completed in PV-10 Immunology
Mechanism of Action Trial
Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT,
http://www.pvct.com), a clinical-stage oncology and dermatology
biopharmaceutical company (“Provectus”), today provides the market
with a business update that addresses several matters.
The Company noted that an amended phase 3 protocol for the
testing of PV-10, its novel investigational drug for cancer, for
the treatment of melanoma has been submitted to the U.S. Food and
Drug Administration (the "FDA"). There were a number of minor
changes made to the protocol that the Company discussed in its
press release of February 9, 2015, which addressed the FDA review.
The Company does not require additional FDA review to start the
phase 3 study, and has begun the process of gaining IRB approval
for the amended protocol
(https://clinicaltrials.gov/show/NCT02288897).
In addition, the Company’s study of PV-10 for liver tumors is
continuing to accrue patients, in particular those with tumors
metastatic to the liver
(https://clinicaltrials.gov/show/NCT00986661). The Company
expects to report initial data at one or more international cancer
conferences this summer.
Also with regard to study enrollments, the Company announced
that enrollment has begun in its mechanism of action [MOA] study
for PH-10, its topical investigational drug for dermatology
(https://clinicaltrials.gov/show/NCT02322086). The Company
expects to recruit up to 30 patients at three study centers in the
U.S. At the same time, Provectus announced the completion of
enrollment in the PV-10 MOA study, meeting the target of enrolling
15 patients in the study
(https://clinicaltrials.gov/show/NCT01760499). Enrollment
and data collection for the PH-10 study are expected to be
completed in December 2015. The Company expects further data from
the PV-10 MOA study to be reported later this year or early in
2016.
The Company also noted that enrollment is continuing under its
expanded access protocol for PV-10, with well over 100 melanoma
patients having received PV-10 in the U.S. and Australia
(https://clinicaltrials.gov/show/NCT01260779).
The Company noted that the January 2015 allowance of its novel
synthesis patent application by the Chinese Patent Office,
following on the issuance of the parent case in the U.S. in
September 2013, represents a continued expansion of its global
patent strategy, in particular protecting the key component of both
PV-10 and PH-10 in major markets. Such process patents serve to
strengthen its product-specific patents, such as U.S. Patent No.
8,974,363 issued earlier this week covering PH-10.
Provectus will also hold its year-end quarterly business update
conference call at 4 p.m. (EDT) today to provide a detailed
business update on PV-10 and PH-10 to the investment community and
answer questions from investors.
Those who wish to participate in the conference call may
telephone 877-407-4019 from the U.S. International callers may
telephone 201-689-8337, approximately 15 minutes before the call. A
webcast will also be available at Provectus’s website,
www.pvct.com. A digital replay will be available by telephone
approximately two hours after the completion of the call until
March 31, 2015, and may be accessed by dialing 877-660-6853 from
the U.S. or 201-612-7415 for international callers, and using the
Conference ID# 13601930.
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 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, CFO,
COO866-594-5999 #30orPorter, LeVay & Rose, Inc.Marlon Nurse,
DM, SVP – Investor Relations212-564-4700orBill Gordon – Media
Relations212-724-6312
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