Provectus Pharmaceuticals Reports to Shareholders on 2009 Accomplishments and Clinical Development Plans
KNOXVILLE, Tenn.--(BUSINESS WIRE)--Jan 7, 2010 - Provectus Pharmaceuticals, Inc. (OTC BB: PVCT) reports on its 2009 clinical and corporate accomplishments, as well as 2010 clinical development plans, in a letter to shareholders from Craig Dees, Ph.D., CEO of Provectus.
Your management team's enthusiasm continues as we prepare the company for some very important steps in our development. With our dermatology Phase 2 trials completed, the melanoma Phase 2 trial nearly completed, two expanded access (“compassionate use”) programs in place and a key Phase 1 trial underway (assessing PV-10 for use against cancers of the liver), there is a lot to be excited about, on both the clinical development and corporate fronts.
Highlights of our technical developments in 2009
Within the last several months, we completed subject accrual in three Phase 2 trials– one for PV-10 for metastatic melanoma, and two for our dermatologic candidate, PH-10. The PH-10 trials were for psoriasis and atopic dermatitis. Achieving these three milestones, all within a few months of each other, was a remarkable feat for our company.
To clarify the clinical development path for PV-10, we have requested a Type B end of Phase 2 meeting with the FDA for the first quarter of 2010. During this meeting we expect to discuss the steps needed to both achieve registration of PV-10 for our lead indication (metastatic melanoma) and receive Fast Track status. This meeting has been a key part of our overall development plan for PV-10 since 2007, and with final data from our Phase 2 melanoma trial arriving in recent months, this is an ideal time to review these safety and efficacy results with the Agency. This is one of the most important meetings we will hold with the FDA, as it should determine whether an accelerated path is appropriate or if a Phase 3 trial under a Special Protocol Assessment will be necessary to gain marketing approval. We have already received orphan drug status for PV-10 for metastatic melanoma, and this meeting will provide crucial guidance for our next steps in the approval process.
One of the highlights of 2009 was the presentation of interim data from our Phase 2 study of PV-10 for metastatic melanoma at the 2009 American Society of Clinical Oncology (ASCO) Scientific Program in May and June, by Dr. Sanjiv S. Agarwala, Principal Investigator from the PV-10 trial's site at St. Luke's Hospital & Health Network in Bethlehem, PA. The abstract, entitled “Chemoablation of melanoma with intralesional rose bengal (PV-10)”, reported that for the first 40 subjects, a 60% objective response rate was achieved with a 75% rate of loco-regional control of treated lesions. As observed in our previous Phase 1 study, a substantial number of these subjects exhibited evidence of a bystander effect, where it appears that PV-10 ablation induces the subject's immune system to fight untreated tumors elsewhere in the body.
But our progress didn't stop there. Favorable survival data from the Phase 2 study of PV-10 for melanoma study was subsequently reported in November 2009. At the 3rd World Meeting of Interdisciplinary Melanoma/Skin Cancer Centers in Berlin, Professor John F. Thompson, MD, Professor of Melanoma and Surgical Oncology at the University of Sydney, Director of the Melanoma Institute Australia, and Lead Investigator of the Phase 2 study, reported that initial one year overall survival data from the first 20 subjects in the current Phase 2 trial showed comparable trends to those of the Phase 1 trial, where markedly longer overall and disease specific survival were observed for subjects that were responsive to PV-10 relative to those who did not experience a robust response.
Based upon requests from physicians, we initiated two expanded access programs (“compassionate use”) for PV-10 in Australia and the U.S. These are active at five of our Phase 2 study centers. A total of 20 melanoma patients, 8 of whom have crossed over from the Phase 2 study to receive further treatment, have commenced treatment with PV-10 under the program. A majority of these patients are in long-term follow-up for up to two years.
Building on this positive experience with PV-10 for treatment for certain cutaneous cancers, we initiated a Phase 1 study to assess safety of PV-10 for treatment of certain liver cancers. In this study, we hope to demonstrate that PV-10, which has shown excellent selectivity for melanoma, will be a viable therapeutic for hepatocellular carcinoma and other cancers that have metastasized to the liver.
In parallel with PV-10, PH-10 is rapidly advancing through clinical trials for its lead dermatological indications. Positive preliminary results from our Phase 2 studies of PH-10 in psoriasis and atopic dermatitis were announced, illustrating the drug's potential effectiveness as a treatment for serious dermatological diseases and providing compelling data to attract licensure agreements. For psoriasis, preliminary data show that 79% of 29 subjects in the trial demonstrated improvement in the Psoriasis Severity Index (PSI) during four weeks of daily treatment with PH-10. In addition, 83% of subjects reported no or only mild pruritus (itching) by week four of the trial. For atopic dermatitis (“eczema”), preliminary data from the first 18 subjects indicated that 94% had improvement in Eczema Area Severity Index (EASI) scores during four weeks of treatment. In both studies the treatments were generally well tolerated with no significant safety issues identified.
We are seeking licensure of PH-10 for treatment of serious dermatological diseases, based on these interim results and milestones we have achieved for PH-10. With the help of investment bankers, we are in discussions with possible industry partners to co-develop the product as we seek to maximize PH-10's potential. We have also had initial meetings with potential licensees of our PH-10 technology and expect more interest in coming months as we continue to pursue a relationship that will benefit the company and our shareholders.
Highlights of our corporate developments in 2009
We have ample cash on our balance sheet to fund our activities through the end of 2010. With an estimated $300,000 needed for the completion of our current clinical trials, our $4 million in cash as of September 30, 2009 will be ample for our development and general corporate purposes through the end of 2010.
Increased visibility in the investment community through participation in industry conferences; also achieved coverage by a second brokerage firm. Throughout the year our management team participated in industry and growth conferences, and met with institutional investors to increase visibility and enhance shareholder value. Initiation of coverage by a second independent brokerage firm also enhanced the company's visibility.
We have reason to be optimistic about the future
We intend to continue to push aggressively ahead in our war against cancer. The first 40 subjects to complete participation in our Phase 2 clinical trial of PV-10 in metastatic melanoma have had results that fit our expectations. We look forward to providing additional interim results as we collect and analyze final data from all 80 subjects. According to the American Cancer Society, in 2008 there were approximately 62,000 new cases of melanoma in the U.S., leading to more than 8,000 deaths. Further, the World Health Organization has projected that 48,000 patients globally died from melanoma in 2008. We believe PV-10 can have a positive impact on this horrendous disease, and look forward to furthering its clinical development in 2010.
Similarly, we are pleased about progress with PH-10 for psoriasis and atopic dermatitis. According to the National Institutes of Health, as many as 7.5 million Americans, or approximately 2.2 percent of the U.S. population, have psoriasis. The National Psoriasis Foundation reports that approximately 125 million people worldwide, 2 to 3 percent of the total population, have psoriasis. It also reports that total direct and indirect health care costs of psoriasis for patients exceed $11 billion annually. Additionally, the National Eczema Association estimates that atopic dermatitis affects more than 30 million Americans. Accordingly, PH-10 appears to have potential to have a major positive impact as well.
In summary, Provectus continues to make progress in its clinical development efforts, having made solid progress with both PV-10 and PH-10. We believe our clinical results indicate excellent potential to help treat deadly diseases such as cancer and have a positive impact on serious dermatological conditions. Our sound financial footing heading into the new year will allow us to continue progress towards registration.
We thank you, our shareholders, for your continued support as we implement our clinical development and commercialization plans.
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 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.
Contact: Provectus Pharmaceuticals, Inc.
Peter R. Culpepper, CFO, COO
Porter, LeVay & Rose, Inc.
Marlon Nurse, VP – Investor Relations
Bill Gordon, SVP – Media Relations
Posted: January 2010