Provectus Reports on Successful End-of-Phase 2 Meeting with U.S. FDA and Gains Clarity for Licensure of PV-10 for Metastatic Melanoma
Thursday April 29, 2010

KNOXVILLE, Tenn.--(BUSINESS WIRE)--Provectus Pharmaceuticals, Inc. (OTCBB: PVCT, http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, announced today that it has held an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to seek consensus on clinical program scope and endpoints for licensure of PV-10 for metastatic melanoma. The meeting was held at the Agency's White Oak Campus in Silver Spring, MD.

Craig Dees, Ph.D., CEO of Provectus said, "This meeting provided an opportunity to thoroughly review the clinical data we have amassed through our Phase 1 and Phase 2 studies with PV-10. As expected, the meeting was fruitful and provided a forum for discussion of appropriate endpoints for assessment of clinical benefit of PV-10 in melanoma patients and for definition of the pathway leading to licensure."

Dr. Dees continued, "Based on consultation with senior Agency officials during this meeting, we expect to hold a second end-of-Phase 2 meeting in the coming months to finalize design of a pivotal Phase 3 randomized controlled study suitable for Special Protocol Assessment (SPA)."

Dr. Dees concluded, "We are fortunate that our capital resources afford flexibility to consider pursuing both the conventional Phase 3 pathway, as well as an accelerated route to licensure. While we believe the Phase 3 with an SPA represents an industry standard path to approval, we believe the door may still be open for accelerated approval."

About PV-10

PV-10 is a proprietary, injectable formulation of Rose Bengal, a compound that has been in use for nearly 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 is a small molecule agent with 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.

About Provectus Pharmaceuticals, Inc. (www.pvct.com)

Provectus Pharmaceuticals specializes in developing oncology and dermatology therapies. Its lead oncology agent, 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 liver cancer. The Company has received orphan drug designation from the FDA for its melanoma indication. Its lead dermatological drug, PH-10, also targets abnormal or diseased cells, with the current focus on psoriasis and atopic dermatitis. Provectus has recently completed enrollment in three of its Phase 2 trials -- PV-10 as a therapy for metastatic melanoma, and PH-10 as a topical treatment for atopic dermatitis and for psoriasis. It has also recently initiated a Phase 1 trial for PV-10 for liver cancer. 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.

Contact:

 

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