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Dear Shareholders:
I am pleased to report that 2009 has already been a year of continued progress and excitement for Provectus. Our clinical trials for both PV-10 and PH-10 have shown promising results. We have completed patient accrual in two of our ongoing Phase 2 trials -- PV-10 for metastatic melanoma and PH-10 for atopic dermatitis.
We believe the results show that PV-10 can be a viable treatment for metastatic melanoma, and we are focusing our efforts on completing the 80 patient study, while also making plans for our next steps in development. Those next steps include seeking licensure agreements and/or partnerships to proceed through final development, and ultimately, bringing the product to market. In addition, we intend to meet with the FDA to determine exactly what steps we need to take to obtain approval of PV-10 for metastatic melanoma.
Compelling data was presented at the American Society of Clinical Oncology (ASCO) meeting in May/June 2009. Interim data from the first 40 subjects in our Phase 2 clinical trial for the treatment of metastatic melanoma demonstrated an objective response (i.e. meaningful response) in 60% of subjects, with 75% of subjects achieving locoregional disease control of their treated lesions. Just over half (52%) of subjects had one or more evaluable untreated bystander lesions, and 48% of these subjects exhibited an objective response in those lesions. This bystander response was strongly correlated with successful destruction of the subject's PV-10 injected lesions, with 69% of these bystander responses occurring among subjects whose injected lesions responded to PV-10.
Researchers concluded that PV-10 is well-tolerated, eliciting a robust response in a majority of patients. The safety and efficacy profile compare favorably with existing and emerging therapies, making PV-10 suitable for repeat treatment of patients with partially-responsive lesions or new lesions to maximize response and long-term outcome.
What does this mean? These interim data demonstrate that PV-10, injected directly into melanoma tumors, can selectively kill the cancerous tumor tissue, and may also stimulate the patient's immune system to destroy untreated tumors elsewhere in the body.
Why are we so excited about these results? As many of you know, no new treatments have been approved in over a decade for this devastating disease. It is a very difficult disease to treat, as evidenced by recent disappointments in clinical trials for other developmental therapies. Our encouraging results with PV-10 suggest that the prognosis for this disease could improve in the future.
In addition to its indications for metastatic melanoma, we believe that PV-10 has potential to be used for other difficult to treat cancers, such as liver cancer and recurrent breast cancer. We are preparing to begin a Phase 1 clinical trial for liver cancer to test this hypothesis.
We also have instituted a compassionate use program for PV-10. Compassionate use programs make investigational drugs available to patients prior to FDA approval. Under this program, PV-10 will be available only for cancer indications that do not involve visceral organs and are not subject to enrollment in ongoing clinical trials. These indications include certain breast cancers, melanoma and non-melanoma skin cancers, and head and neck cancers. Provectus has begun its compassionate use program for PV-10 in certain Australian "Centers of Excellence," including our Phase 2 sites in Sydney and Brisbane, and we plan to expand it to the United States in coming months. The Australian program is under the guidelines of the Therapeutic Goods Administration's Special Access Scheme, while the U.S. program is expected to be under the FDA's regulations covering expanded access to an investigational new drug. There has been quite a bit of demand for PV-10, and we are pleased to be able to provide a limited supply through this program.
We are also making progress with PH-10, a topical formulation of Rose Bengal, which is being tested for atopic dermatitis and psoriasis. While not life threatening, these chronic diseases can be extremely unpleasant, and many of the available treatments have unhealthy side effects. We recently completed patient accrual for our Phase 2 study of PH-10 for atopic dermatitis, and expect to be able to release data later this year. Importantly, the completion of patient accrual triggered a milestone for us to seek either a licensing partner or a co-developer for the product. We have begun to hold preliminary discussions with interested parties and are pursuing a relationship that will benefit the company and our shareholders. Based on the successful protocol for the atopic dermatitis study, we initiated a new Phase 2 clinical study of PH-10 for psoriasis. This new study supplants the earlier Phase 2 study that was terminated in June. These indications are of significant scale, as atopic dermatitis and psoriasis affect millions of Americans. The National Eczema Association estimates that atopic dermatitis affects more than 30 million Americans, and, according to the National Institutes of Health, as many as 7.5 million Americans, approximately 2.2 percent of the population, have psoriasis. The National Psoriasis Foundation reports that approximately 125 million people worldwide have psoriasis.
As large pharma continues to seek ways to increase their new product pipelines, through licensing agreements or acquisitions, we are pleased to see the interest in the area of melanoma treatments. We believe that Provectus' PV-10 is a compelling therapy that could add significant value to these pipelines. As Provectus has reached that important stage of its development, our business development team is pursuing opportunities with other companies and/or organizations to further the development of our lead product candidates while maximizing shareholder value.
In summary, Provectus continues to make inroads in the war against cancer. The first 40 patients in our Phase 2 clinical trial of PV-10 in metastatic melanoma have had results that fit our internal expectations. We look forward to providing additional interim results as we complete the analysis of all 80 patients. In addition, we are pleased with the progression of PH-10 for both atopic dermatitis and psoriasis. Both PV-10 and PH-10 have given Provectus a solid foundation to develop and implement a strategic plan to enhance shareholder value. Thank you for your continued support.
Sincerely,
Craig Dees, Ph.D.
Chairman and Chief Executive Officer
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 their 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 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.
SOURCE Provectus Pharmaceuticals, Inc.
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