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): March 16, 2016
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 March 16, 2016, Provectus Biopharmaceuticals, Inc. (the Company), issued a press release (the Press Release)
announcing that the protocol for its phase 3 clinical trial for PV-10 as an investigational treatment for melanoma has been amended to reflect current and evolving standards of care and applicable patient
population for a global study in 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.
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Exhibit
Number |
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Description |
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99.1 |
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Press Release, dated March 16, 2016 |
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: March 16, 2016
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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 Interim Chief Executive
Officer, 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 March 16, 2016 |
Exhibit 99.1
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Contact: Provectus Biopharmaceuticals, Inc.
Peter R. Culpepper, Interim CEO, 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
Allison + Partners Todd Aydelotte, Managing Director Media
Relations Phone: 646-428-0644 |
FOR IMMEDIATE RELEASE
PROVECTUS BIOPHARMACEUTICALS AMENDS PROTOCOL FOR PHASE 3 STUDY
OF PV-10 IN TREATMENT OF LOCALLY ADVANCED CUTANEOUS MELANOMA
Protocol Amended to Reflect Current and Evolving
Standard of Care and Applicable Patient Population
KNOXVILLE, TN, March 16, 2016 Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, www.pvct.com), a clinical-stage oncology and dermatology
biopharmaceutical company (Provectus or The Company), today announced that the protocol for its phase 3 clinical trial for PV-10 as an investigational treatment for melanoma has
been amended to reflect current and evolving standards of care and applicable patient population for a global study in melanoma.
Major amendments to the
protocol include the addition of talimogene laherparepvec (ImlygicTM) as an option for use as comparator. The amended protocol also extends eligibility to include Stage IV M1a patients
having no active nodal or distant cutaneous or subcutaneous metastatic disease. These patients have disease characteristics and prognosis similar to that of the Stage IIIB and IIIC patients that initially defined the study patient population.
In addition, the updated protocol clarifies eligibility for patients not having access to immune checkpoint inhibitors due to standard of care and those
not having access to targeted therapy due to standard of care, as well as inclusion of patients who have failed targeted therapy. In the latter case, patients who have failed targeted therapy but meet study eligibility criteria have similar disease
manifestations to the remaining study population but have limited treatment options.
Dr. Eric Wachter, CTO of Provectus, said, These kinds of
amendments are commonplace in phase 3 studies and serve to fine-tune the patient population and study procedures to match changing care standards for a large global study. They are the direct result of current and emerging options for these
patients and have been developed with extensive input from global leading melanoma investigators. In particular, the most obvious amendment addresses approval in late October of Imlygic by the FDA as the first and only oncolytic viral therapy. As we
implement the amended protocol we will assess potential impact on study timelines.
For further information about the study, please visit
https://clinicaltrials.gov/ct2/show/NCT02288897.
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 investigational drug product for melanoma 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; |
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our ability to license PH-10, our investigational drug product for dermatology, 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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