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 20, 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 20, 2015, Provectus Biopharmaceuticals, Inc.
issued a press release (the Press Release) announcing that it has received from the US Patent and Trademark Office a Notice of Allowance for a joint patent application made with Pfizer, Inc. The patent will protect use of PV-10 in
combination with certain other types of drugs in the treatment of melanoma and cancers of the liver. 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
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Description |
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99.1 |
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Press Release, dated April 20, 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 20, 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 20, 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 |
PFIZER AND PROVECTUS BIOPHARMACEUTICALS RECEIVE PATENT ALLOWANCE FOR
USE OF PV-10 IN COMBINATION WITH SYSTEMIC IMMUNOTHERAPY AGENTS IN
TREATMENT OF CANCER
KNOXVILLE, TN,
April 20, 2015 Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, http://www.pvct.com), a clinical-stage oncology and dermatology biopharmaceutical company (Provectus or the Company), announced today that it has
received from the US Patent and Trademark Office a Notice of Allowance for a joint patent application made with Pfizer, Inc. The patent will protect use of PV-10 in combination with certain other types of drugs in the treatment of melanoma and
cancers of the liver.
The allowed claims cover use of PV-10 in combination with systemic inhibitors of immune system down-regulation, such as
anti-CTLA-4, PD-1 and PD-L1 antibodies, along with enhancers of immune system up-regulation, such as IL-2 and interferon-gamma. Pre-clinical testing of PV-10 used in combination with these important classes of drugs demonstrated potential importance
for treatment of advanced cancers.
The Company hopes that the patent protection afforded by the Notice of Allowance will enable Provectus to realize
financial rewards if clinical research demonstrates that PV-10 used in combination with one or more of these other drugs improves patient outcomes.
Data
on the invention has been presented at several international meetings since 2013:
At the Society for Immunotherapy of Cancers (SITC)
29th Annual Meeting in November 2014, Dr. Shari Pilon-Thomas of the Moffitt Cancer Center presented a poster, entitled Intralesional Injection with PV-10 in Combination with Co-Inhibitory Blockade in a Murine Model of Melanoma. She
concluded that the new data support combination therapy with IL PV-10 and co-inhibitory blockade.
At the American Association
for Cancer Research (AACR) Annual Meeting in April 2013, Dr. Wachter, Ph.D., Chief Technology Officer of Provectus, presented a poster entitled, Combination of PV-10 Immuno-chemoablation and Systemic Anti-CTLA-4 Antibody Therapy in Murine
Models of Melanoma. At the time, Wachter commented, This work shows that, as hypothesized, addition of the immunologic effects of an anti-CTLA-4 agent augments the benefits of PV-10. For visceral or other inaccessible disease,
combination of PV-10 with CTLA-4 blockade offers important potential for synergy.
Dr. Eric Wachter noted The forthcoming patent arose from discussions several years ago with
Dr. Craig Eagle of Pfizer, and appropriately given his contribution he is named as the lead inventor for these claims. In addition to the claimed combinations of PV-10 with immunotherapy agents, the specification covers combination with other
classes of agents, and Provectus will pursue these areas through one or more divisional application.
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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