Provectus Biopharmaceuticals Extends for Additional 60 Days Memorandum of Understanding with Sinopharm-China State Institute ...
May 18 2015 - 06:00AM
Business Wire
Provectus Biopharmaceuticals, Inc. (NYSE MKT:PVCT,
http://www.pvct.com), a clinical-stage oncology and dermatology
biopharmaceutical company (“Provectus” or the “Company”), today
announced that it had extended for an additional 60 days its
Memorandum of Understanding with with Sinopharm-China State
Institute of Pharmaceutical Industry ("Sinopharm-CSIPI"), the
leader among all pharmaceutical research institutes in China, and
Sinopharm A-THINK Pharmaceutical Co., Ltd. ("Sinopharm A-THINK"),
the only injectable anti-tumor drug research and development,
manufacture and distribution integrated platform within Sinopharm
Group. The extension was the only change to the agreement, and the
MOU is now in force through July 15, 2015.
The original MOU was signed in August 2014, and since then, the
parties have sought to enter into a definitive licensing agreement,
subject to additional negotiation, due diligence, and any required
regulatory and corporate approvals. The original MOU was to be in
effect for 90 days, and in November 2014 it was extended through
May 16, 2015.
Since the signing of the MOU, management of Provectus and senior
personnel at Sinopharm-CSIPI and Sinopharm A-THINK have held
numerous conference calls, have met face-to-face in both China and
the US, and Chinese scientists on staff at Sinopharm have discussed
in person PV-10 and its clinical results with the lead
investigators at St. Luke’s University Hospital and Health Network
and Moffitt Cancer Center.
Dr. Craig Dees, PhD, Chief Executive Officer of Provectus
stated, “We remain optimistic that a definitive licensing agreement
with our Chinese partners can be achieved. The extra time is needed
to ensure that nothing in the agreement undermines the legal
position of Provectus or Sinopharm under Chinese or American law,
and to ensure that the timetable for all deliverables is realistic
– and clearly defined taking into account the regulations regarding
new drug applications under the Chinese regulatory system.”
Dr. Zhidan Jia, Chief Executive Officer of Sinopharm A-THINK,
said, “We believe that the original terms of the MOU are still in
our best interests and those of our partners at Provectus, and we
took great comfort from the opening of enrollment for the phase 3
trial for the use of PV-10 as a treatment for melanoma. We believe
that the next 60 days will be productive, and that both sides will
be content with the outcome.”
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, including its current phase 3 study in melanoma,
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 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 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20150518005448/en/
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
Provectus Biopharmaceuti... (QB) (USOTC:PVCT)
Historical Stock Chart
From Feb 2024 to Mar 2024
Provectus Biopharmaceuti... (QB) (USOTC:PVCT)
Historical Stock Chart
From Mar 2023 to Mar 2024