UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant
to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 13, 2014
PROVECTUS BIOPHARMACEUTICALS, INC.
(Exact name of registrant as specified in charter)
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Delaware |
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001-36457 |
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90-0031917 |
(State or other jurisdiction
of incorporation) |
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(Commission
File Number) |
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(IRS Employer
Identification No.) |
7327 Oak Ridge Hwy., Knoxville, Tennessee 37931
(Address of Principal Executive Offices)
(866) 594-5999
(Registrants Telephone Number, Including Area Code)
(Former Name or Former Address, If Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the
following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 7.01. |
Regulation FD Disclosure. |
On November 13, 2014, Provectus Biopharmaceuticals, Inc.
(the Company), issued a press release (the Press Release), announcing that the protocol for the phase 3 study of PV-10 as a treatment for melanoma is now available online at
http://clinicaltrials.gov/ct2/show/study/NCT02288897?term=provectus&rank=6. A copy of the Press Release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Pursuant to the rules and regulations of the Securities and Exchange Commission, the information in this Item 7.01 disclosure, including
Exhibit 99.1 and information set forth therein, is deemed to have been furnished and shall not be deemed to be filed under the Securities Exchange Act of 1934.
Item 9.01. |
Financial Statements and Exhibits. |
(d) Exhibits.
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Exhibit
Number |
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Description |
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99.1 |
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Press Release, dated November 13, 2014 |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
Date: November 13, 2014
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PROVECTUS BIOPHARMACEUTICALS, INC. |
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By: |
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/s/ Peter R. Culpepper |
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Peter R. Culpepper |
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Chief Financial Officer and Chief Operating Officer |
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EXHIBIT INDEX
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Exhibit Number |
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Description |
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99.1 |
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Press Release, dated November 13, 2014 |
Exhibit 99.1
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Contact: Provectus Biopharmaceuticals, Inc.
Peter R. Culpepper, CFO, COO Phone: 866-594-5999 #30 |
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Porter, LeVay & Rose, Inc.
Marlon Nurse, DM, SVP Investor Relations Phone:
212-564-4700 Bill Gordon Media Relations Phone:
212-724-6312 |
PROVECTUS BIOPHARMACEUTICALS PROTOCOL FOR PHASE 3 STUDY OF PV-10 AS TREATMENT FOR MELANOMA NOW
AVAILABLE ONLINE
KNOXVILLE, TN, November 13, 2014 - Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, http://www.pvct.com), a
development-stage oncology and dermatology biopharmaceutical company (Provectus), announced today that the protocol for its phase 3 study of PV-10 as a treatment for melanoma is now available on:
http://clinicaltrials.gov/ct2/show/study/NCT02288897?term=provectus&rank=6
The protocol states that the study is an international multicenter, open-label, randomized controlled trial (RCT) of single-agent intralesional PV-10
versus systemic chemotherapy with dacarbazine (DTIC) or temozolomide (TMZ) to assess treatment of locally advanced cutaneous melanoma in patients who are BRAF V600E wild-type and have failed or are not otherwise candidates for ipilimumab or another
immune checkpoint inhibitor. Subjects in the comparator arm will receive the Investigators choice of dacarbazine or temozolomide as determined by Investigator preference and/or local availability of the agent. Effectiveness will be assessed by
comparison of progression-free survival (PFS) between all intent-to-treat (ITT) subjects in the two study treatment arms.
The Primary Outcome
Measure is progression-free survival (PFS) to be assessed every 12 weeks up to 18 months.
The Secondary Outcome Measures include complete response rate
(CRR) and its duration (to be assessed every 12 weeks up to 18 months); the change in total symptom score from baseline using the patient reported Skindex-16 instrument (to be assessed 12 weeks after Day 1); Overall survival (OS) to be assessed
every 12 weeks up to 18 months; and number of participants with adverse events assessed every 4 weeks until 28 days after last treatment.
Safety and
tolerability will be assessed by monitoring the frequency, duration, severity and attribution of adverse events and evaluating changes in laboratory values and vital signs.
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 Companys other clinical trials can be found at the NIH registry, www.clinicaltrials.gov. For additional
information about Provectus, please visit the Companys 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 managements current knowledge, assumptions, beliefs, estimates, and expectations and express
managements 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:
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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; |
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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; |
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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 |
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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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