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 5, 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 November 5, 2015, Provectus Biopharmaceuticals, Inc. (the Company) issued a press release (the Press Release)
announcing that researchers from Moffitt Cancer Center in Tampa, Florida, presented a poster titled, Intralesional Rose Bengal in Melanoma Elicits Tumor Immunity via High Mobility Group Box 1, at the Society for Immunotherapy of Cancer
30th Anniversary Annual Meeting in National Harbor, Maryland. A copy of the Press Release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
The Company is holding its 2015 third quarter business update conference call at 5 pm Eastern Standard Time today to provide a business update
on PV-10 and PH-10 to the investment community and answer questions from investors. A digital replay will be available by telephone approximately two hours after the completion of the call until January 31, 2016 and may be accessed by dialing
877-660-6853 from the U.S. or 201-612-7415 for international callers, and using the Conference ID #13623105. A webcast is also available during and after the call until February 5, 2016 at www.investorcalendar.com/event/174450. A full copy of the
transcript will be available on the Companys website within 24 hours of the conference call.
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 5, 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: November 5, 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 |
EXHIBIT INDEX
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Exhibit Number |
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Description |
99.1 |
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Press Release, dated November 5, 2015 |
Exhibit 99.1
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Contact: |
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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 Todd
Aydelotte - Media Relations Phone: 646-428-0644 |
FOR IMMEDIATE RELEASE
PROVECTUS BIOPHARMACEUTICALS REPORTS IMMUNE MECHANISM OF ACTION
DATA FOR PV-10 PRESENTED AT SOCIETY FOR IMMUNOTHERAPY OF CANCER
ANNUAL MEETING AUTHORED BY RESEARCHERS AT MOFFITT CANCER CENTER
Poster Titled, Intralesional Rose Bengal in Melanoma Elicits Tumor Immunity via High
Mobility Group Box 1 Available on Company Website
KNOXVILLE, TN, November 5, 2015 Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, http://www.pvct.com), a clinical-stage oncology and
dermatology biopharmaceutical company (Provectus), today announced that researchers from Moffitt Cancer Center in Tampa, Florida, presented a poster titled, Intralesional Rose Bengal in Melanoma Elicits Tumor Immunity via High
Mobility Group Box 1, at the Society for Immunotherapy of Cancer (SITC) 30th Anniversary Annual Meeting in National Harbor, Maryland.
Authors Hao Liu, Pasquale Patrick Innamarato, Krithika Kodumudi, Amy Weber, John L Robinson, Satoshi Nemoto, Georgina Crago, Timothy McCardle, Erica Royster,
Amod A Sarnaik and Shari Pilon-Thomas state that their results reveal a clinically relevant immunoadjuvant pathway triggered by tumor cell death secondary to ablation with RB. The data presented were from nonclinical models of melanoma
in mice and clinical data from the teams recent clinical mechanism of action study (Clinical Trials ID NCT01760499). To view the poster, visit http://www.pvct.com/publications/SITC-Poster-2015.pdf.
In the reported work, the authors showed that tumor-specific T cells were increased in the blood of both mouse and man after tumor ablation with PV-10. This
was initiated by tumor cell necrosis, leading to release of High Mobility Box Group 1 (HMBG1), one of a class Damage-Associated Molecular Pattern molecules (DAMPs) released by dying cancer cells that can lead to activation of dendritic cells. HMBG1
release was observed in vitro and after ablation of melanoma tumors in mice and clinical trial participants. This was also correlated with dendritic cell activation and infiltration into lymph nodes draining ablated tumors.
Eric Wachter, Ph.D., Chief Technology Officer of Provectus, observed, The data reported by our collaborators at Moffitt further clarify the mechanism by
which tumor ablation with PV-10 can initiate a finely tuned immune response against injected tumor cells. This has important potential implications for overall response and durability of response when PV-10 is used as a single agent therapy, while
the central role played by T cells in this response is notable for combination of PV-10 with other agents that function on T cells.
-more-
Provectus is currently enrolling patients in a phase 3 study of PV-10 as a single agent therapy for patients with
locally advanced cutaneous melanoma (Clinical Trials ID NCT02288897) and in a phase 1b study of PV-10 in combination with the immune checkpoint inhibitor pembrolizumab in patients with metastatic melanoma (Clinical Trials ID NCT02557321).
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, 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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