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Provectus News

Provectus Biopharmaceuticals Announces Leadership Changes

Monday February 29, 2016

KNOXVILLE, Tenn.--(BUSINESS WIRE)--Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, www.pvct.com) announced today several leadership changes following the resignation of one of its Co-Founders and its Chairman and CEO, H. Craig Dees, PhD.

The Provectus Board of Directors accepted the resignation of Dr. Dees, which he submitted due to personal and health reasons, in a telephonic Board meeting over the weekend. Alfred E. Smith, IV, lead independent director, was selected to replace Dr. Dees as Board Chairman. Peter R. Culpepper, current Provectus CFO and COO, was named Interim CEO. Eric Wachter, current Provectus CTO, also was added to the Board to fill Dr. Dees' vacancy.

"I look forward to working with our Board and our many consultants and corporate partners to continue our clinical development for the benefit of patients and stockholders alike," Interim CEO Culpepper said.

The Board also formed a Search Committee, to be chaired by Board Chairman Smith, to immediately begin work to identify a permanent CEO.

Smith commended Dr. Dees' role in the company's history and development of PV-10, the company's novel investigational drug for cancer, and PH-10, the company's topical investigational drug for dermatology.

"We wish Craig the very best," said Smith. "He has helped bring us to this stage of the company's development. We are optimistic about the company's current position and confident that the team which Craig helped build will continue his work."

The Board added that in this transition it has designated the company's Audit Committee to review a number of company procedures, policies and practices, including executive compensation and expenses. Smith said results of that review will be released when completed.

A Reuters article featured by Fortune last week said that Provectus' PV-10, "stands out for its simplicity" as a possible new cancer treatment. Dees, a former scientist at Oak Ridge National Laboratory (ORNL), founded Provectus in 2002 and located its headquarters near ORNL in Knoxville, Tennessee.

Provectus will hold a conference call for stockholders and the market on Tuesday, March 1, 2016 at 4:00 p.m. (EST) to discuss these leadership changes and answer questions from investors. Call-in information will be made public later today.

The complete press release is available at www.pvct.com/pressrelease.html?article=20160229.1 on the Provectus website.

Provectus Biopharmaceuticals Initiating Phase 1 Study of PV-10 in Neuroendicrine Tumors Metastatic to Liver

12-Patient Study to be Conducted at The Queen Elizabeth Hospital, Woodville, South Australia

Monday February 29, 2016

KNOXVILLE, Tenn.--(BUSINESS WIRE)--Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, www.pvct.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus" or the "Company" , today announced that it is initiating a protocol titled, "A Phase 1 Study to Assess the Safety, Tolerability and Effectiveness of PV-10 Chemoablation of Neuroendocrine Tumours (NET) Metastatic to the Liver in the Reduction of Biochemical Markers and Symptoms Caused by Secretory Products."

The 12-patient phase 1 study will run up to 48 months with interim data anticipated at the half-way point of the two-cohort study. Patients in the first of the two successive cohorts will receive PV-10 to a single NET tumor in their liver, while patients in the second cohort may receive PV-10 to multiple NET tumors.

Timothy Price, M.D. will serve as principal investigator for the study at The Queen Elizabeth Hospital in Woodville, South Australia.

Dr. Price explained, "The primary endpoint of our study will be assessment of safety and tolerability of PV-10 in the treatment of these metastatic NETs. Our secondary endpoints address preliminary efficacy, disease symptoms and biomarkers, and include assessments of Objective Response Rate (ORR) of injected and uninjected tumors; change in tumor biomarkers (somatostatin receptor expression, chromogranin A and 5-hydroxyindole acetic acid); change in NET symptoms assessed by standard quality of life instruments; and possible change in peripheral blood mononuclear cells (PBMCs)."

Dr. Eric Wachter, CTO of Provectus, noted, "This protocol is a natural complement to work ongoing in our initial study of hepatic cancers under protocol PV-10-LC-01, which has allowed us to assess PV-10 in a number of tumor types using the method of administration that will be used in this new study. In addition to providing further data on the overall safety of this approach, this study is tailored to NET patients and will allow us to assess potential clinical benefit in terms of objective response and changes in biomarkers and symptoms of these tumors. Patients with metastatic NET tumors are often plagued by persistent diarrhea, flushing, breathing difficulties, abdominal cramping and swelling of the arms and legs. It will be very useful to determine whether PV-10 ablates NET tumors and if ablation has a positive impact on quality of life for patients."

For further information, please visit https://www.clinicaltrials.gov/ct2/show/NCT02693067. The study is expected to open for enrollment in March 2016.

The complete press release is available at www.pvct.com/pressrelease.html?article=20160229.2 on the Provectus website.
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