N@N

Provectus Pharmaceuticals Updates Shareholders on 2008 Accomplishments

^{Published on 2009-01-06 04:22:00, Last Modified on 2009-01-06 04:24:40 - Market Wire}
 

KNOXVILLE, Tenn.--([ BUSINESS WIRE ])--Provectus Pharmaceuticals, Inc. (OTC BB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, reports on its clinical and corporate accomplishments for 2008 in a letter to shareholders from Craig Dees, Ph.D., CEO of Provectus.

Dear Shareholders:

2008 was a momentous year for Provectus as our team achieved many important and exciting milestones. We continued to make great strides in helping to combat disease based upon our proprietary formulations of Rose Bengal. We continued to develop both of our therapeutic platforms, PV-10, which is in development as a therapeutic agent for a broad spectrum of cancers, and PH-10, which is being developed for dermatology indications. Much of our focus this year was on PV-10 for metastatic melanoma, a drug that been granted orphan drug designation from the FDA for this indication.

We believe there is a critical need for new treatment approaches for metastatic melanoma, a deadly disease for which there are few approved therapies. While the recent ‘Annual Report to the Nation on the Status of Cancer, 1975-2005 Featuring Trends in Lung Cancer, Tobacco Use and Tobacco Control' published in the December 2, 2008 Journal of the National Cancer Institute reported the overall decline in death rates and incidence of cancers for both men and women, sadly, the incidence rates of melanoma, for both men and women actually increased during this time period. The statistics are alarming. According to the American Cancer Society, approximately 120,000 patients in the U.S. have Stage III or Stage IV melanoma, and they estimate that in 2008 there will be more than 62,000 new cases of melanoma in the U.S., with more than 8,000 patients expected to die from this disease in the U.S. alone. Further, the World Health Organization reports that it expects 48,000 patients globally will have died from melanoma in 2008.

Our clinical trials for PV-10 for metastatic melanoma advanced during the year, and enrollment in the Phase 2 trial reached its midpoint in November. Importantly, the first peer reviewed publication for PV-10 appeared in "Melanoma Research", first online in October and then in the print edition in December. Additionally, Professor John F. Thompson, Principal Investigator for the trial, appeared at two important international oncology and melanoma conferences where he presented updates on our clinical program. We also greatly expanded the number of sites of the Phase 2 trial, and recently opened our seventh site; this site marks our fourth site in the U.S., with the remaining three sites in Australia. Depending on the rate of enrollment at our current sites, we will evaluate the need to open additional sites for the Phase 2 trial, as we may be able to enroll 80 subjects without an additional site.

While much of our focus has been on PV-10 for the metastatic melanoma indication, we have also been working on PV-10 for recurrent breast cancer and on developing PH-10 for dermatological indications. We remain in solid financial shape for the funding of all trials in progress, and have benefited from the continued support of our warrant holders.

Following is a summary of Provectus Pharmaceuticals' achievements for 2008:

CLINICAL TRIALS FOR PV-10 FOR METASTATIC MELANOMA; INTERIM RESULTS; PEER REVIEWED PUBLICATION AND CONFERENCES:

• Reached Midway Point for Enrollment in PV-10 Trials for Metastatic Melanoma - Provectus initiated treatment of the 40^th melanoma subject (out of 80 total) in its Phase 2 clinical trial of PV-10 for metastatic melanoma.
• Expanded Sites in Australia and the U.S.- The Phase 2 trials are currently being conducted at three Australian sites (Adelaide, Brisbane and Sydney), and at four U.S. sites (M.D. Anderson Cancer Center in Houston, Texas, St. Luke's Hospital & Health Network in Bethlehem, PA, the California Pacific Medical Center in San Francisco, CA and the University of Louisville in KY.). Provectus announced it will evaluate the need to open additional sites to complete the 80 subject study, depending on the rate of enrollment for this trial.
• Published First Peer-Reviewed Publication on PV-10 for Metastatic Melanoma was Published in "Melanoma Research." Entitled "Chemoablation of metastatic melanoma using intralesional Rose Bengal," the article, authored by Professor John F. Thompson, M.D. and his colleagues, Professor Peter Herse, M.D. and Eric Wachter, Ph.D. appeared on the publication's website in October, and in print in December. The paper presented clinical data for the first 11 subjects Provectus' Phase 1 clinical trial of PV-10. The preliminary efficacy and side-effect results from single intralesional ("IL") treatment sessions with PV-10 compared favorably with those of other IL regimens for melanoma. Dr. Thompson noted that the findings indicated that IL Rose Bengal is nontoxic and could benefit patients with metastatic melanoma.
• Presented a Paper at the "Perspectives in Melanoma XII" Conference meeting at The Hague, The Netherlands, in October, detailing data from the completed Phase 1 trial and providing an update on the Phase 2 trial.Professor Thompson presented data from the Phase 1 trial that demonstrated PV-10 was well tolerated and appeared to trigger a response in the immune system of a number of subjects, enabling their bodies to attack uninjected melanoma tumors in a process called the "bystander effect". When injected into melanoma tumors, PV-10 appeared to kill the tumors by a process called chemoablation while leaving surrounding healthy tissue undamaged. Thompson reported that injected tumors started to die within several days.
• Professor Thompson Presented an Update on Clinical Testing of PV-10 for Metastatic Melanoma at the Clinical Oncological Society of Australia's 2008 Annual Meeting in November. Professor Thompson presented updated long-term survival data for subjects participating in phase 1 testing of PV-10 and noted that there is a statistically significant difference in survival between those subjects that achieved an objective response of their PV-10 injected melanoma lesions, with a median survival of 30.7 months vs. 12.3 months for subjects that failed to respond to PV-10. He noted that the data suggest that response of treated lesions may be a good predictor of long-term outcome, as only one of the eight subjects in the positive response group had died of melanoma.

PV-10 FOR RECURRENT BREAST CANCER:

• We Completed our Phase 1 Clinical Trial of PV-10 for the Treatment of Recurrent Breast Carcinoma in October. Phase 1 goals were to determine the safety of the treatment and the appropriate dosage, and also to demonstrate that PV-10 has multi-indication potential. Both of these goals were successfully met, and Provectus is in a position for a Phase 2 study of PV-10 for recurrent breast cancer.

DERMATOLOGY- PH-10 FOR ATOPIC DERMATITIS:

• In May Provectus Began a Phase 2 Clinical Trial of PH-10, a Topical Formulation of Rose Bengal for Dermatology, for Atopic Dermatitis. The study is evaluating safety and efficacy of PH-10 in a total of twenty subjects with mild to severe forms of the disease. The daily application of the drug in the study will also provide relevant information for the treatment of other dermatologic conditions, including psoriasis and infectious diseases of the skin, including antibiotic resistant Staphylococcus aureus (MRSA), a growing public health concern. The study is being conducted at International Dermatology Research Inc. of Miami, Florida.

DEEPENED PATENT PORTFOLIO:

• Our Patent Portfolio was Expanded During The Year and now Includes 23 U.S. Patents and 29 Foreign Issued Patents. We received patents and patent allowances in several different countries this year, including India, the U.S., Europe and China, covering PV-10, PH-10 and a related novel agent PH-12.

FINANCIAL- AMPLE FUNDING FOR CLINICAL TRIALS:

• We Received Approximately $2.6 Million From the Conversion of Outstanding Warrants, Providing Additional Cash to Fund Operations. We have spent approximately $4.5 million on R & D, with an additional $1.5 million slated in our budget. We believe we have ample cash on hand to complete the development of our current trials—PV-10 Phase 2 for Metastatic Melanoma; PH-10 Phase 2 for Psoriasis and Atopic Dermatitis, Phase 1 for liver cancer, as well as other development activities.

CORPORATE- EXPANDED BOARD OF DIRECTORS AND SCIENTIFIC ADVISORY BOARD; NEW INVESTOR PRESENTATION ON WEBSITE:

• We Added More Depth to our Boards, with the Appointment of Kelly M. McMasters MD, Ph.D., a preeminent authority on melanoma to serve on our Board of Directors and to also head our scientific advisory board. The addition of Dr. McMasters provides us a wealth of experience for our current and future clinical trials, as well as invaluable assistance in corporate governance.
• We Updated our Investor Presentation on our Website. The presentation now includes comparisons of Provectus to other companies in its peer group as well as the dates that it expects to announce preliminary results of the PV-10 Phase 2 clinical trial. The updated presentation can be found at the following link on the company's website: [ http://www.pvct.com/presskit.html ].

We appreciate the contributions made by our corporate team as well as our team of investigators, as we continue to advance our mission of improving the prognosis for patients with critical or chronic diseases. 2008 was an extremely busy and productive year, one in which we made great progress. We look forward to the opportunities that 2009 will bring to us, and thank our shareholders for their continued support.

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

Provectus Pharmaceuticals is a development stage company that specializes in oncology and dermatology therapies that are safer, more effective, less invasive and more economical than conventional therapies. Provectus is currently conducting Phase 2 clinical trials of its proprietary drugs PV-10 as a therapy for metastatic melanoma and PH-10 as a topical treatment for psoriasis and atopic dermatitis. Information about these and the Company's other clinical trials can be found at the NIH registry, [ www.clinicaltrials.gov ]. The Company has received orphan drug designation from the FDA for its melanoma indication. Complementing their suite of proprietary drugs, Provectus has developed a number of intellectual properties and technologies in the areas of imaging, medical devices and biotechnology. 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.