KNOXVILLE, Tenn.--(BUSINESS WIRE)--Provectus Pharmaceuticals, Inc. (OTCBB: PVCT, http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, has announced interim data from the first 40 subjects in its Phase 2 clinical trial for the treatment of metastatic melanoma. PV-10 treatment was well tolerated and elicited selective ablation of tumors in the majority of subjects. Additional data on untreated tumors corroborated observations of a possible bystander effect seen during earlier Phase 1 testing. These data were presented today at the American Society of Clinical Oncology 2009 Annual Meeting, Abstract #9060, entitled "Chemoablation of melanoma with intralesional rose bengal (PV-10)," in the General Poster Session.
Key interim data from the first 40 subjects in the Phase 2 study included:
"These data provide us much encouragement as they continue to demonstrate how potentially safe and effective PV-10 is for the treatment of metastatic melanoma," said Dr. Sanjiv Agarwala, Principal Investigator for Provectus' Phase 2 PV-10 trial site at St. Luke's Hospital & Health Network in Bethlehem, PA, who presented the abstract at ASCO. "Particularly positive is further evidence of the 'bystander effect,' which appears to induce the patient's immune system to attack and shrink untreated tumors. Because melanoma often metastasizes in areas of the body that are difficult to treat, such as the head and neck, the 'bystander effect' could dramatically improve the prognosis for many patients. We are excited about these results and look forward to continued development of this therapy."
Dr. Craig Dees, PhD, Chairman and Chief Executive Officer of Provectus said, "The progress we are making in the clinical trials of PV-10 helps pave the way for its possible future as a safe and effective therapy for metastatic melanoma patients. The results presented from the first 40 subjects in the Phase 2 trial bring us another step closer to helping the many thousands of individuals afflicted each year with this insidious disease, whose incidence is rising faster than any other cancer in the U.S. today."
The American Cancer Society estimates that there are 120,000 patients in the United States with Stage III or Stage IV melanoma, and that 68,000 new cases will be reported in 2009. The World Health Organization reported that it expected 48,000 global deaths in 2008 alone from Stage III or Stage IV melanoma.
Dr. Agarwala added, "Advanced melanoma is an extremely difficult disease to treat, even with the approved chemotherapy or immunotherapy drugs that exist. In the last decade there have not been any new drugs approved for melanoma, which demonstrates how resistant this devastating disease is to the traditional methods of treatment. That is one of the many reasons that I find these newly published data very important and am encouraged by their implications."
Background and Summary of the Data Presented at ASCO (Abstract # 9060):
Expanded Phase 2 testing of PV-10 commenced in late 2007 in 80 subjects with Stage III or IV melanoma, and enrollment was completed in May 2009. Enrollment for this multi-center study was conducted at seven sites in Australia and the United States. Thirty five subjects with Stage III disease and five with Stage IV disease comprised the cohort analyzed, with a median of 8 lesions treated per subject over 2 treatment cycles. The reported safety and efficacy data demonstrate that therapy with PV-10 compares favorably with available therapeutic options for this patient population.
PV-10 treatment was generally well tolerated, with most adverse effects transient, locoregional and mild to moderate in severity. Locoregional pain (reported by 60% of subjects), vesicles (30%), edema (28%) or swelling (18%) were most common. Severe (Grade 3) adverse effects were relatively rare (1 case each of vesicles, cellulitis and skin flap necrosis and 2 cases of severe pain), with no Grade 4 or 5 adverse effects attributed to PV-10. These results were comparable to observations from Phase 1 testing of PV-10.
Interim efficacy data for the first 40 subjects were also comparable to that of Phase 1, with 30% of subjects achieving a Complete Response (CR), and an additional 30% of subjects achieving a Partial Response (PR) in their treated lesions during the first 24 weeks following initial PV-10 treatment, for an Objective Response (OR) of 60%; Stable Disease (SD) was achieved by 15% of subjects, while 25% experienced Progressive Disease (PD), equating to a 75% rate of locoregional disease control of treated lesions. Just over half (52%) of subjects had one or more evaluable untreated bystander lesion, and 48% of these subjects exhibited an improvement in their bystander lesions qualifying as a CR (24%) or PR (24%); an additional 14% achieved SD in these lesions, for a 62% rate of locoregional disease control of bystander lesions. As previously reported for Phase 1 testing, this apparent bystander effect was strongly correlated with successful ablation of the subject's PV-10 injected lesions, with a majority of bystander responses qualifying as a CR or PR (OR = 69%) among those subjects that achieved an OR of their injected lesions. In contrast, subjects that did not achieve an OR in their injected lesions experienced minimal benefit (12% OR) in their non-injected bystander lesions.
In addition to these Phase 2 results, extended survival data were reported from the Phase 1 study, showing a survival advantage in terms of both overall survival (median 42.1 months vs. 12.3 months) and disease specific survival (44.1 months vs. 14.6 months) for subjects that achieved an OR in the Phase 1 study versus those that did not respond so robustly to PV-10. Such data support a possible systemic benefit for PV-10.
The poster presentation can be accessed by the following link:
PV-10 is 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.
Provectus Pharmaceuticals, Inc. Peter R. Culpepper, CFO, 866-594-5999 #30 or Porter, LeVay & Rose, Inc. Marlon Nurse, VP - Investor Relations, 212-564-4700 Bill Gordon, SVP - Media Relations, 212-564-4700
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