Provectus Reports on Presentation of Chemoablation of Metastatic Melanoma from Joint Meeting of 7th World Congress on Melanoma and 5th Congress of the European Association of Dermato-Oncology
—PV-10 Elicits a Robust Response in Many Patients—
The presentation, entitled, “Chemoablation of metastatic melanoma with intralesional PV-10” was given by Dr. Sanjiv Agarwala, M.D., a principal investigator for Provectus' Phase 2 clinical trial investigating the effectiveness of intralesional (IL) PV-10 for locoregional treatment of metastatic melanoma.
The Phase 2 study commenced in late 2007 in 80 subjects with Stage III or IV melanoma, and enrollment was completed in May 2009. Subjects received an initial treatment of 1-20 lesions, with retreatment possible at weeks 8, 12 or 16. An additional 1-2 lesions could remain untreated for assessment of bystander response. Interim assessment of safety was performed 4 weeks and efficacy 24 weeks after treatment of the 20th and 40th subjects, with final follow-up at 52 weeks. The primary end-point is objective response (OR) of injected lesions; secondary endpoints include OR of bystander lesions and progression free survival (PFS).
Interim safety data for the first 40 subjects was comparable to Phase 1, with transient locoregional pain (reported by 60% of subjects), vesicles (30%), edema (28%) and local swelling (18%) most common; Grade 3 AEs have been rare, with no higher grade AEs attributed to PV-10. Interim efficacy for the first 20 subjects in Phase 2 was enhanced over Phase 1 (30% CR + 30% PR in Phase 2 versus 20% CR + 20% PR in Phase 1). As noted in Phase 1, an apparent bystander response was noted in some subjects, with 62% of subjects exhibiting locoregional disease control (CR, PR or SD) of their untreated bystander lesions. Bystander response was statistically better in subjects experiencing a robust response in their PV-10 injected lesions: 60% of subjects whose lesions responded to PV-10 achieved an objective response in their bystander lesions vs. none in the group failing to respond to PV-10.
Dr. Agarwala said, “I am pleased to have had the opportunity to present these data at the Joint Meeting of the 7th World Congress on Melanoma and 5th Congress of the European Association of Dermato-Oncology. The robust response of many of the subjects to PV-10, combined with PV-10's safety and efficacy profile, are important factors as we work towards a treatment to help those patients suffering with the devastating effects of metastatic melanoma. Additionally, the results of the ˜bystander' effect are very encouraging as melanoma can metastasize throughout the body to areas that are difficult to treat. In the context of existing and other emerging treatments for metastatic melanoma, these results are very encouraging.”
Dr. Craig Dees, PhD, Chief Executive Officer of Provectus said, “There is a large, unmet demand for a safe and effective treatment for metastatic melanoma. 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 2009 there will be more than 68,000 new cases of melanoma in the U.S., with more than 8,600 patients expected to die from this disease in the U.S. alone. Further, the World Health Organization reported that it expected 48,000 patients globally to die from melanoma in 2008. These dramatic estimates demonstrate the important role that PV-10 could play in the treatment of this deadly disease. We look forward to our continued research and to communicating additional results from the Phase 2 trial at ASCO on June 1, 2009.”
PV-10 is based on a proprietary, injectable formulation of Rose Bengal, a compound that has been in use for nearly thirty years by ophthalmologists and optometrists to assess damage to the eye. It has also been used to detect ailments of the liver. Rose Bengal has an established safety history, a short half-life in the bloodstream, and is excreted via the liver and kidneys. Provectus has discovered a novel use for Rose Bengal based on the observation that it is selectively toxic to cancer calls via a process called chemoablation whereby cells undergo a form of cell death that mimics both features of necrosis and apoptosis.
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.
Contact: Provectus Pharmaceuticals, Inc.
Peter R. Culpepper, CFO, 866-594-5999 #30
Porter, LeVay & Rose, Inc.
Marlon Nurse, VP – Investor Relations
Bill Gordon, SVP – Media Relations
Posted: May 2009