Provectus Biopharmaceuticals, Inc. (NYSE MKT:PVCT,
http://www.pvct.com), a development-stage oncology and dermatology
biopharmaceutical company ("Provectus"), announced today that it
has agreed to extend the term of its existing Memorandum of
Understanding (MOU) 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 to May 16,
2015. The MOU remains in effect and unchanged other than this
extension of the term.
During the last 90 days, 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 Cancer Center and
Moffitt Cancer Center.
Dr. Zhidan Jia, Chief Executive Officer of Sinopharm A-THINK,
echoed these sentiments saying, "I am happy with the progress we
made so far as our relationship with PVCT moves forward. Sinopharm
will do more research on the recent filed PV-10 Phase 3 trial
protocol. It will allow us to understand the drug better, and will
help both parties to move forward in the Chinese market."
The Company stated that it is hopeful that a contract will be
finalized in the coming weeks, and this extension illustrates that
there is sufficient interest on both sides to continue to work out
the details. With the new data from the Moffitt Cancer Center on
combination therapy with IL PV-10 and co-inhibitory blockade, and
considering Provectus’ filing of the phase 3 protocol with the FDA
in Washington, both parties agreed to take the additional time
needed to ensure that the final contract is the best agreement
possible for everyone.
The MOU will now terminate upon the signature of a licensing
agreement or other contract, on May 16, 2015, or with one-month
written notice by either party.
About Sinopharm
China National Pharmaceutical Group Corporation, (Sinopharm) is
the largest medical and healthcare group in China which is directly
managed by the State-owned Assets Supervision and Administration
Commission of the State Council (SASAC), with the core businesses
of distribution, logistics, retail, scientific research and
manufacture of healthcare related products. Sinopharm owns 10
wholly owned or holding subsidiaries, and 5 listed companies
including Sinopharm Group Co., Ltd. (01099.HK), China National
Medicines Co., Ltd. (600511.SH), Beijing Tiantan Biological
Products Co., Ltd. (600161.SH), Shyndec Pharmaceutical Co., Ltd.
(600420.SH) and Shenzhen Accord Pharmaceutical Co., Ltd.
(200028.SZ). The sales revenue of Sinopharm exceeded RMB 160
billion in 2012. It is the only Chinese pharmaceutical company
whose sales revenue exceeds RMB 100 billion.
For more information, visit: http://www.sinopharm.com.
About Sinopharm-China State Institute of Pharmaceutical
Industry
Sinopharm-China State Institute of Pharmaceutical Industry
originated from the Shanghai Institute of Pharmaceutical Industry
which was founded in 1957. Sinopharm-CSIPI is a top bio-science
research and pharmaceutical application-base research institute in
China, with the core businesses of innovation drug development,
distribution, logistics, and scientific research of healthcare
related products. It is one of the National Pharmaceutical
Technology Innovation Bases.
For more information, visit: http://www.csipi.com.cn.
About Sinopharm A-THINK Pharmaceuticals Co., Ltd.
Sinopharm A-THINK Pharmaceuticals Co., Ltd., founded in 1997,
focuses on injectable anti-tumor and anti-hepatitis product
development. Sinopharm A-THINK is the only anti-tumor and
anti-virus drug development and manufacture integrated platform
within Sinopharm Group, with the core business of new Oncology drug
R&D, manufacture and distribution throughout China.
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, June 30, 2014, and September 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.
Provectus Biopharmaceuticals, Inc.Peter R. Culpepper, CFO, COO,
866-594-5999 #30orPorter, LeVay & Rose, Inc.Investor
RelationsMarlon Nurse, DM, SVP, 212-564-4700orMedia RelationsBill
Gordon, 212-724-6312
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