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): April 15, 2015
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 April 15, 2015, Provectus Biopharmaceuticals, Inc.
(the Company), issued a press release (the Press Release), announcing that the Company had opened enrollment of patients for its phase 3 clinical trial of PV-10 as a treatment for melanoma. 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 April 15, 2015 |
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: April 15, 2015
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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 April 15, 2015 |
Exhibit 99.1
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Contact: |
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Provectus Biopharmaceuticals, Inc. |
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Porter, LeVay & Rose, Inc. |
Peter R. Culpepper, CFO, COO |
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Marlon Nurse, DM, SVP Investor Relations |
Phone: 866-594-5999 #30 |
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Phone: 212-564-4700 |
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Bill Gordon Media Relations |
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Phone: 212-724-6312 |
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FOR IMMEDIATE RELEASE |
PROVECTUS BIOPHARMACEUTICALS OPENS PATIENT ENROLLMENT; BEGINS PHASE 3 INTERNATIONAL FDA COMPARATIVE CLINICAL
TRIAL OF PV-10 FOR MELANOMA
Interim Data Expected When 50% of Events Achieved
KNOXVILLE, TN, April 15, 2015 Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, http://www.pvct.com), a clinical-stage oncology and dermatology
biopharmaceutical company (Provectus or the Company), enters phase 3 and has opened enrollment of patients for its phase 3 international FDA comparative clinical trial of PV-10 for melanoma. The Company is seeking 225
patients and enrollment has begun at St. Lukes University Hospital and Health Network, Bethlehem, PA, the first study site to be opened, with additional sites to be added in the coming weeks and months.
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 V600 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); and Overall survival
(OS) to be assessed every 12 weeks up to 18 months.
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. For more details on the study, please visit https://www.clinicaltrials.gov/ct2/show/NCT02288897
Top-line results from the phase 2 trial have been posted on clinicaltrials.gov, for the study entitled Phase 2 study of Intralesional PV-10 for
Metastatic Melanoma, [NCT00521053]. https://clinicaltrials.gov/ct2/show/NCT00521053.
For a complete history of Provectus research into
PV-10 as a treatment for melanoma, visit https://www.pvct.com/pv10melanoma.html
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, 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 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); |
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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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