PVCT Provectus Biopharmaceuticals Inc (QB)

 

 

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): May 21, 2014

 

 

PROVECTUS BIOPHARMACEUTICALS, INC.

(Exact name of registrant as specified in charter)

 

 

 

Delaware		001-36457		90-0031917
(State or other jurisdiction		(Commission		(IRS Employer
of incorporation)		File Number)		Identification No.)

7327 Oak Ridge Hwy., Knoxville, Tennessee 37931

(Address of Principal Executive Offices)

(866) 594-5999

(Registrant’s 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:

 

¨	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 

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Item 7.01.

Regulation FD Disclosure.

On the afternoon of May 21, 2014, Provectus Biopharmaceuticals, Inc. (the “Company”) received a notice from the Food and Drug Administration (the “FDA”) denying the Company’s request for designation of the Company’s oncology drug, PV-10, as a Breakthrough Therapy treatment. On May 23, 2014, the Company issued a press release announcing the FDA’s denial. A copy of the Company’s press release, attached hereto as Exhibit 99.1, and the FDA’s letter denying Breakthrough Therapy designation, attached hereto as Exhibit 99.2, are incorporated herein by reference.

 

Item 9.01.

Financial Statements and Exhibits.

 

(d)

Exhibits.

 

Exhibit Number		Description
99.1		Press Release, dated May 23, 2014
99.2		FDA notice, dated May 16, 2014*

 

*	Confidential treatment has been requested for portions of Exhibit 99.2. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of Exhibit 99.2 has been filed separately with the Securities and Exchange Commission.

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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: May 23, 2014

 

 

2

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EXHIBIT INDEX

 

Exhibit Number		Description
99.1		Press release, dated May 23, 2014
99.2		FDA notice, dated May 16, 2014

Exhibit 99.1

 

 

Contact:
Provectus Biopharmaceuticals, Inc.		Porter, LeVay & Rose, Inc.
Peter R. Culpepper, CFO, COO		Marlon Nurse, DM, SVP – Investor Relations
Phone: 866-594-5999 #30		Phone: 212-564-4700
		Bill Gordon – Media Relations
		Phone: 212-724-6312

FOR IMMEDIATE RELEASE

PROVECTUS BIOPHARMACEUTICALS INC. REAFFIRMS ITS COMMITMENT TO

BRINGING PV-10 TO MARKET NOTWITHSTANDING FDA DECISION ON

BREAKTHROUGH THERAPY DESIGNATION

PATH FORWARD TO BE COMMUNICATED JUNE 2^ND AT ASCO

CONFERENCE CALL SCHEDULED TODAY AT 4 PM EDT

KNOXVILLE, TN, May 23, 2014 — Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT) (http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, has received notification from the United States Food and Drug Administration that the data upon which the Company based its request for designation of PV-10 as a Breakthrough Therapy for the treatment of patients with locally advanced cutaneous melanoma was insufficient to demonstrate substantial improvement over existing therapies. As a result, the FDA has declined to designate PV-10 as a Breakthrough Therapy at this time. Further data may cause the Agency to revisit this decision at a later date. PV-10 is the Company’s novel investigational drug for solid tumors.

In the notification letter the FDA stated, “We have reviewed your request and while we have determined that treatment of ‘locally advanced cutaneous melanoma’ meets the criteria for a serious or life-threatening disease or condition, the preliminary clinical evidence you submitted does not indicate that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. Therefore, designation as a Breakthrough Therapy cannot be granted at this time.”

Dr. Craig Dees, PhD, CEO of Provectus noted, “Given that only about one third of requests are granted, and no intralesional drugs have received designation, we fully understand the regulatory challenges these types of drugs face. This effort, while not initially successful, will benefit the company in pursuing available approaches for approval of PV-10.

Dees continued, “We are very happy that the Agency recognized that locally advanced cutaneous melanoma is a serious condition and consider that a win for melanoma patients. We believe that elimination of these patients’ tumors is clinically relevant, but as we alluded to in our January 24, 2014 press release regarding our Type C meeting of December 16, 2013, a focused bridging study appears to be necessary to conclusively establish a link between complete response and symptom-based endpoints.”

 

 

-more-

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Dees concluded, “We are carefully weighing the advice of the Agency and will provide an outline of the path forward for melanoma in our poster presentation June 2^nd at ASCO. We continue to enroll our currently active protocols examining the effect of PV-10 on tumors of the liver; providing expanded access treatment of cutaneous and subcutaneous tumors; and probing the immunologic mechanism of action resulting from tumor ablation with PV-10. With adequate available capital we are in a strong position to execute the necessary steps to bring PV-10 to market for solid tumors and continue development of PH-10 for dermatologic indications.”

A copy of the Agency’s notification letter will be filed as an attachment to a SEC form 8-K. The clinical data submitted in the request will be presented at the American Society of Clinical Oncology (ASCO) annual meeting on Monday, June 2.

In the request, Provectus presented an analysis of the sub-group of 54 patients in phase 2 study PV-10-MM-02 having melanoma confined to cutaneous and subcutaneous sites and where all disease was followed; any new clinically relevant disease constituted progression with no further assessment for response. Complete response of all injected lesions was observed in 37% of these patients (95% confidence interval 24-51%). In 28 of these patients having all of their baseline disease injected, complete response was observed in 50% of patients (CI 31-70%).

Conference Call Today at 4 PM EDT

The management of Provectus Biopharmaceuticals, Inc. will host a conference call today at 4 PM Eastern. Those who wish to participate in the conference call may telephone 877-407-4019 from the U.S. International callers may telephone 201-689-8337, approximately 15 minutes before the call. A webcast will also be available at: www.pvct.com.

A digital replay will be available by telephone approximately two hours after the completion of the call until July 23, 2014, 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#13583661.

About Provectus Biopharmaceuticals, Inc.

Provectus Biopharmaceuticals 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 recently 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 Company’s other clinical trials can be found at the NIH registry, www.clinicaltrials.gov. For additional information about Provectus please visit the Company’s website at www.pvct.com or contact Porter, LeVay & Rose, Inc.

FORWARD-LOOKING STATEMENTS: The forward-looking statements contained herein are subject to certain risks and uncertainties that could cause actual results to differ materially from those reflected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect management’s analysis only as of the date hereof. The company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date hereof.

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Exhibit 99.2

 

		DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

IND ***

DENY -

BREAKTHROUGH THERAPY DESIGNATION

Provectus Pharmaceuticals,

Inc. Attention: Eric

Wachter, Ph.D. Chief

Technology Officer

7327 Oak Ridge Highway,

Suite A Knoxville, TN 37931

Dear Dr. Wachter:

Please refer to your Investigational New Drug Application (IND) submitted under section 505(i) of the Federal Food, Drug, and Cosmetic Act for “PV-10 (rose bengal disodium in 0.9% saline).”

We also refer to your March 21, 2014, request for Breakthrough Therapy designation for treatment of locally advanced cutaneous melanoma. Furthermore, we refer to our comments and information requests made via email communication on April 11, 2014, and to your amendment dated April 14, 2014, containing your responses to the April 11, 2014 communication.

We have reviewed your request and while we have determined that treatment of “locally advanced cutaneous melanoma” meets the criteria for a serious or life-threatening disease or condition, the preliminary clinical evidence you submitted does not indicate that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. Therefore, designation as a Breakthrough Therapy cannot be granted at this time.

The preliminary clinical data provided in your request for Breakthrough Therapy designation are indicative of drug activity in the treatment of local, satellite or in-transit recurrence of malignant melanoma; however, the preliminary clinical data do not demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. This determination is based on the paucity of data on endpoints indicative of clinical benefit (e.g., pain, infection, significant bleeding) and our inability to determine the clinical significance of the reduction in the size in one to 10 target lesions in patients with locally advanced melanoma, who may have additional untreated cutaneous, subcutaneous, or visceral sites of disease. The information provided on durability of response is also of unclear clinical

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IND 70539

Page 2

 

significance given the modifications to RECIST. Finally, there was also insufficient information provided in the package to ascertain improvement in or relief of tumor-related symptoms of pain, bleeding, or tumor ulceration. We acknowledge that a subset of patients with pre-treatment pain was identified, with summary data presented for two post-treatment time-points (at 8 and 13 weeks). However, from the information provided using visual analogue scale (VAS) for assessment of pain is incomplete as it did not capture pain throughout the course of treatment, no information on concomitant pain medications were provided, and it is not clear that the results observed were clinically significant, as no information was provided on validation of the VAS instrument used.

FDA previously communicated concerns regarding the development program and provided advice regarding the type of data that should be systematically collected to investigate the clinical benefit(s) of an intratumoral treatment of a subset of individual lesions in a systemic disease (malignant melanoma), as previously discussed at the April 8, 2010, March 7, 2011, and October 18, 2011, end-of-Phase 2 meetings and the December 16, 2013 General Guidance teleconference.

Please note that your request for Breakthrough Therapy designation was discussed with representatives from the Center for Drug Evaluation and Research (CDER) and from the Office of New Drugs (OND) and Office of Medical Policy (OMP) within CDER, who concurred with the Division’s assessment.

You may submit a new request if you obtain new clinical evidence that PV-10 demonstrates a substantial improvement over existing therapies on one or more clinically significant endpoints in the treatment of locally advanced cutaneous melanoma.

For further information regarding Breakthrough Therapy designation, refer to section 902 of the Food and Drug Administration Safety and Innovation Act (FDASIA) and the draft Guidance for Industry: Expedited Programs for Serious Conditions – Drugs and Biologics (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ UCM358301.pdf )

For further information regarding Fast Track, refer to the draft guidance noted in the above paragraph.

If you have any questions, contact ***, Regulatory Health Project Manager, at ***.

 

Reference ID: 3507777

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This is a representation of an electronic record that was signed

electronically and this page is the manifestation of the electronic signature.

 

 

 

/s/

PATRICIA KEEGAN

05/16/2014

 

***

Indicates a portion of this document has been omitted and filed separately with the Secretary of the United States Securities and Exchange Commission pursuant to Provectus Biopharmaceutical, Inc.’s, application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934.

Reference ID: 3507777