Dear Shareholders:
During 2010 we continued to navigate the course to commercialization for both our oncology and dermatology therapies, paving the way for us to begin 2011 with a solid start to the year. With so much of the groundwork having been accomplished during the past few years, and substantial progress made during 2010, we look forward to achieving several significant milestones again this year.
In addition to the progress we have been making at Provectus, we are also encouraged about the excitement surrounding the Food and Drug Administration’s ("FDA") approval of the first new melanoma therapy in almost 15 years. This approval has brought a lot of needed attention to this devastating disease, and highlights our mission to provide a safe and efficient therapy to patients who previously had little recourse in their fight against cancer.
We moved both PV-10 for metastatic melanoma and PH-10 for atopic dermatitis and psoriasis through the completion of Phase 2 trials, and commenced a Phase 2C trial for PH-10 to support our licensure efforts while remaining a financially secure company.
We made substantial clinical progress during the year, which demonstrates the strength of our product portfolio:
We completed our Phase 2 study of PV-10 for metastatic melanoma and presented positive results at major scientific conferences, including ASCO in June 2010 (American Society of Clinical Oncology), and the Melanoma 2010 Congress in Sydney, Australia in November 2010.
Phase 2 studies of PH-10 were completed for both psoriasis and atopic dermatitis, with positive outcomes
We initiated a Phase 2C study of PH-10 for psoriasis to support licensure activities. This randomized controlled study is making rapid progress with more than half of the anticipated 90 subjects enrolled, representing our largest dermatological clinical trial in our history. This study will be used as part of our discussions with potential partners, several of whom have requested this study for further evaluation. Study completion is expected during the fourth quarter of 2011.
We are planning a PV-10 Phase 2B study of immunological response to better define selectivity and bystander effects of PV-10. The study, which is currently being designed, is expected to commence in the second half of 2011. Non-clinical testing in tumor models is underway to identify clinical targets for confirmation in the clinical subjects.
We are gathering a growing body of clinical evidence that supports further investigation of PV-10’s utility and efficacy in treating difficult cancers for which there are few available options.
We completed the PV-10 Phase 1 study in liver cancer, with encouraging results that support a randomized controlled Phase 2 study for hepatocellular carcinoma, which we are in the process of designing. Our Compassionate Use Program for PV-10 for non-visceral cancers is providing us additional data on the use of PV-10 in several cancers besides melanoma. We currently have enrolled over 40 patients at 6 centers; experience from this program is providing us rich information on dosing as well as the potential use of PV-10 for different types of cancers.
There is increased commercial value of our intellectual property with the receipt of FDA Orphan Drug Designation for Rose Bengal for liver cancer.
We received Orphan Drug Designation for Rose Bengal, the active ingredient in PV-10, for the treatment of hepatocellular carcinoma. This designation will provide us market exclusivity and financial and regulatory benefits as we bring PV-10 for liver cancer through the regulatory process towards commercialization.
We are financially secure with cash on hand to support the Company through planned operations and development through 2013.
With the backing of our investors, including the $1 million investment and $30 million commitment of equity capital at our sole discretion by Lincoln Park Capital Fund in December 2010, and the $5.1 million invested directly by some existing investors, we have ample funds available to support our operations for at least two years. We believe this funding places us in a secure position to continue our developmental and regulatory activities.
Our anticipated 2011 milestones will position the Company for regulatory and commercial success.
Our anticipated 2011 milestones will position the Company for regulatory and commercial success. We look forward to achieving further milestones during 2011 including:
With a very successful 2010, we are even more excited about the prospects that 2011 has for our Company as we continue our fight against various cancers and develop therapies for serious dermatological diseases. We thank our investigators and our shareholders for their continued support as we continue our research and development activities leading towards commercializing our novel therapies that, we expect, will have a significant positive impact on patients’ lives.
Sincerely,
Craig Dees, Ph.D., CEO
Provectus Pharmaceuticals
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