Healthcare Industry News:  PH-10 

Biopharmaceuticals Dermatology Oncology

 News Release - July 15, 2010

Provectus Pharmaceuticals Reports Achieved Milestones for First Half of 2010, Recent Developments and Plans for the Remainder of the Year to Shareholders

KNOXVILLE, Tenn.--(HSMN NewsFeed)--Provectus Pharmaceuticals, Inc. (OTC BB: PVCT) reports on its first half 2010 clinical and corporate accomplishments, as well as its clinical development plans, in a letter to shareholders from Craig Dees, Ph.D., CEO of Provectus.

Dear Shareholders:

Provectus has achieved many clinical milestones in 2010. Currently, we are preparing for a follow-up end-of-Phase 2 meeting with the FDA to finalize design plans for a pivotal Phase 3 clinical trial of PV-10 for metastatic melanoma. Likewise, we have significant results from our Phase 2 clinical trials of PH-10 for psoriasis and atopic dermatitis and will be looking for a strategic partner.

Recent Development - Phase 2 Results for PH-10 for Psoriasis and Atopic Dermatitis

Consistent with the preliminary data that we announced in December 2009, 70% of the 30 subjects enrolled in the Phase 2 clinical trial of PH-10 for psoriasis demonstrated improvement in their Psoriasis Severity Index (PSI) scores at the end of four weeks of daily treatment with PH-10. In addition, 86% of subjects reported no or only mild pruritus (itching) by week four of the trial, and no significant safety issues were noted. As we expected, outcome in this study was quite similar to that observed in our phase 2 study of PH-10 for atopic dermatitis, completed earlier last year. In both studies, at the four week interval substantial improvement was observed across all standard disease assessment scores. Since PH-10 is likely to have further efficacy when it is used at higher dose or for more than four weeks, we look forward to continued evaluation of PH-10 over a longer treatment period in keeping with all comparable therapies on the market. With the positive results of these Phase 2 studies now available, we expect to formally engage a financial advisor to assist us with out-licensing PH-10 for the treatment of serious dermatological diseases.

PV-10 Update

In April, we reached an important milestone in our clinical development of PV-10, our experimental therapy for oncology, when we met with the U.S. Food and Drug Administration (FDA) in an end-of-Phase 2 meeting, and received guidance for design of a pivotal Phase 3 randomized controlled trial (RCT) of PV-10 for metastatic melanoma suitable for Special Protocol Assessment (“SPA”). The SPA would affirm that our Phase 3 clinical trial design, endpoints, sample size, planned conduct and statistical analyses would be acceptable for regulatory approval, and would define the regulatory pathway for licensure of PV-10 as a treatment for metastatic melanoma. As a follow-up to this first meeting, we are making plans for a second meeting with the Agency to finalize design of the clinical trial. Once this meeting is held, we expect to begin the Phase 3 trial in early 2011.

We also reported further positive results at the American Society of Clinical Oncology 2010 Annual Meeting (“ASCO”), which was held in early June. Based upon 12 month follow-up of the first 40 subjects in the Phase 2 study, the Objective Response Rate (“ORR”) of PV-10 injected lesions was 60%, with a Complete Response in 33% of subjects, and locoregional disease control in 80% of subjects, ORR of untreated bystander lesions was 43%. Mean progression free survival (“PFS”) was 8.5 months, with the objective response cohort having a significantly longer PFS of at least 11.1 months, vs. 3.0 months for Stable Disease and Progressive Disease subjects. The treatment was well tolerated, with side effects generally mild to moderate, and no deaths or life-threatening occurrences reported from PV-10.

PV-10’s bystander effect is further evidenced with the encouraging and corroborative data on visceral metastases presented at ASCO. Dr. Sanjiv Agarwala, Chief of Medical Oncology and Hematology at St. Luke’s Cancer Center in Bethlehem, PA and Principal Investigator for our Phase 2 clinical site at St. Luke’s, presented information that illustrated the potential systemic benefit from PV-10 ablation of cutaneous lesions. Included in the presentation were data from both the initial 40 subjects as well as several from the final 40 subjects enrolled in the Phase 2 trial. Among the first 40 subjects, Dr. Agarwala reported that 7 of the 16 subjects with visceral or macroscopic nodal metastases at screening exhibited stasis or regression of their lesions. These results are comparable to the responses observed in untreated cutaneous bystander lesions, and underscore the apparent role of the immune system in overall response to PV-10 therapy, providing us with critical insight regarding PV-10’s potential for fighting cancer.

Progress is also being made on our compassionate use program for PV-10, which currently has enrolled over 25 subjects at five of our Phase 2 sites. PV-10 is mainly being used to treat melanoma, and has recently been applied in a case of recurrent squamous cell carcinoma. Overall, response appears to be in line with our Phase 2 results and is yielding valuable perspective on future clinical use.

In addition to these cutaneous indications, we’ve had encouraging results following treatment of two inoperable hepatocellular carcinoma tumors in our Phase 1 trial of PV-10 for liver cancers. This study is assessing safety and preliminary efficacy of PV-10 for treatment of cancers in this critical organ, and could pave the way for substantial expansion of our development program into other visceral sites.

As the magnitude of our clinical results has increased, we have attracted the attention of several leading medical trade publications such as Doctor’s Guide, Hem/Onc Today, Oncology Business Review, Skin & Aging, Practical Dermatology, Bioworld Insight and BioCentury. Provectus and PV-10 have also been covered by broadcast media including Health Radio Network, major newswires like Reuters and Pharmawire, and members of the local and online media.

Financial Update

On the financial front, our balance sheet remains strong, with over $12 million in cash and no debt. We believe we have ample cash to complete all planned programs.

At the end of June, with our market capitalization above $75 million, we became eligible to register securities using a Form S-3, or “shelf” registration process, under Rule 415, and seized the opportunity to do the filing. We believe this shelf registration provides us with flexibility to take advantage of financing opportunities primarily with institutional investors when and if deemed appropriate by us. The registration statement relating to the securities has been filed with the SEC and has become effective. Please note that this letter does not constitute an offer to sell nor the solicitation of an offer to buy, nor shall there be any sale of any securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. Any offering may be made only by means of the prospectus and a related prospectus supplement.

Looking Ahead

While we are very excited about the many advances we have made during these past six months with PV-10 for metastatic melanoma, we are equally excited about what lies ahead in the next several months, not only for PV-10, but for PH-10 as well.

Among the significant expected events, we anticipate scheduling a second meeting with the Australian Therapeutic Goods Administration (“TGA”) to seek the equivalent of accelerated approval of PV-10 for metastatic melanoma in Australia, where melanoma is the fourth most prevalent cancer. According to the Cancer Council of Australia, melanoma represents 10% of all cancers, with more than 10,300 cases diagnosed annually, and approximately 1,250 deaths from the disease each year. Finding a safe and effective treatment for melanoma is a high priority in Australia, and therefore we are looking forward to our discussions with the TGA to discuss the path towards approval.

We eagerly look forward to announcing final study results of the Phase 2 trial of PV-10 for metastatic melanoma at the Melanoma 2010 Conference in Sydney, Australia, November 4-7, 2010. Professor John F. Thompson, M.D. of the Melanoma Institute Australia, and the global lead investigator for the Phase 2 trial, is expected to present complete data on all 80 subjects who participated in the study.

Further, we also expect to commence a proposed Phase 2B clinical trial of PV-10 for metastatic melanoma to examine the immunologic markers behind PV-10’s therapeutic activity. The data presented in June at ASCO illustrate the potential systemic benefit from PV-10 ablation of cutaneous melanoma lesions, and the results of the Phase 2B study should help explain exactly how the immune system responds to tumor ablation with PV-10. We believe the clarity that this study will provide will be extremely helpful, and could be used to petition the FDA for accelerated approval of PV-10.

We also expect progress to continue in our Phase 1 trial of PV-10 for liver cancer, and expect to complete it by the end of the year. The very promising initial results suggest that we should meet all of our primary and secondary endpoints for the study, allowing for rapid expansion of this programmatic area for cancers of the liver and other visceral sites.

And continued progress is exactly what we are focusing on. We believe we are developing targeted therapies capable of treating some of the most devastating diseases that afflict mankind. Getting treatments to market for these diseases is our main concern. The months ahead will be significant ones for Provectus and our shareholders, and we thank you for your continued support. We look forward to sharing our success with you.

Sincerely,

Craig Dees, PhD, CEO of Provectus

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 potential for 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 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 of 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

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