Provectus Biopharmaceuticals Inc (PVCT)

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press release
April 26, 2011, 4:05 p.m. EDT

Provectus Receives Orphan Drug Designation from FDA for the Treatment of Liver Cancer

KNOXVILLE, Tenn., Apr 26, 2011 (BUSINESS WIRE) -- Provectus Pharmaceuticals, Inc. (OTC BB: PVCT, http://www.pvct.com ), a development-stage oncology and dermatology biopharmaceutical company, has received orphan drug designation by the U.S. Food and Drug Administration ("FDA") for Rose Bengal, the active ingredient in its novel oncology drug PV-10, for the treatment of hepatocellular carcinoma ("HCC"), the most common form of primary liver cancer. Provectus completed patient accrual and treatment of all subjects in its Phase 1 clinical trial of PV-10 for liver cancer in January 2011, and is currently designing a Phase 2 study.

Receiving orphan drug designation entitles Provectus to exclusive marketing rights for PV-10 for HCC in the United States for up to seven years if it is the first company to receive marketing approval for this therapeutic drug product. In addition, orphan drug designation allows Provectus to apply for a waiver from the FDA of certain user fees required by the Prescription Drug User Fee Act (PDUFA).

"Receiving orphan drug designation for hepatocellular carcinoma, in combination with our strategy for patent protection of PV-10, is another important step in assuring the value of the company's proprietary property once regulatory approval is achieved," said Dr. Craig Dees, PhD, CEO of Provectus. "Based upon our clinical trials of PV-10 for metastatic melanoma, as well as on the results we are seeing in our Compassionate Use Program for PV-10 for non-visceral cancers, we believe PV-10 will be a safe and effective treatment for many different types of cancers. Preliminary analysis of the results of the Phase 1 liver cancer trial shows that PV-10 should have a role in the treatment of tumors of the liver."

Dr. Dees added, "Orphan drug designation for liver cancer will provide us market exclusivity, as well as financial and regulatory benefits, provided that the trials are completed successfully and the treatment receives FDA approval."

About PV-10

PV-10 is a proprietary, injectable formulation of Rose Bengal, a compound that has been in use for over thirty years by ophthalmologists to assess damage to the eye. It has also been used as an intravenous diagnostic to detect ailments of the liver. Rose Bengal has an established safety history, a short half-life in the bloodstream, and is excreted via the liver and kidneys. Provectus has discovered a novel use for Rose Bengal based on the observation that it is selectively toxic to cancer calls via a process called chemoablation whereby cells undergo a form of cell death that mimics both features of necrosis and apoptosis. Provectus has completed its Phase 2 clinical trial of PV-10 for metastatic melanoma, and is currently in conversation with both the Food and Drug Administration (FDA) regarding the design of a pivotal Phase 3 randomized controlled trial suitable for SPA ("Special Protocol Assessment"), and the Australian Therapeutic Goods Administration to review regulatory approval of PV-10 for melanoma in Australia.

About Provectus Pharmaceuticals, Inc.

Provectus Pharmaceuticals specializes in developing oncology and dermatology therapies. Its novel oncology drug PV-10 is designed to selectively target and destroy cancer cells without harming surrounding healthy tissue, significantly reducing systemic side effects. Its oncology focus is on melanoma, breast cancer and metastatic cancers of the liver. The Company has received orphan drug designations from the FDA for its melanoma and hepatocellular carcinoma indications. Its dermatological drug PH-10 also targets abnormal or diseased cells, with the current focus on psoriasis and atopic dermatitis. Provectus has recently completed its 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 thereof.

SOURCE: Provectus Pharmaceuticals, Inc.




Provectus Pharmaceuticals, Inc.
Peter R. Culpepper, CFO
866-594-5999 #30
or
Porter, LeVay & Rose, Inc.
Marlon Nurse, DM, VP - Investor Relations
Bill Gordon, SVP - Media Relations
212-564-4700




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