Health & Fitness
Mon, December 8, 2008Sun, December 7, 2008Sat, December 6, 2008Fri, December 5, 2008Thu, December 4, 2008Wed, December 3, 2008Tue, December 2, 2008Mon, December 1, 2008Sun, November 30, 2008Fri, November 28, 2008Thu, November 27, 2008Wed, November 26, 2008Tue, November 25, 2008Mon, November 24, 2008Thu, November 20, 2008Wed, November 19, 2008Tue, November 18, 2008Mon, November 17, 2008Enrollment in Provectus Phase 2 Melanoma Clinical Trial Reaches Halfway Point
Published in Health and Fitness on Tuesday, November 25th 2008 at 6:08 GMT by Market Wire
KNOXVILLE, Tenn.--([ BUSINESS WIRE ])--Provectus Pharmaceuticals, Inc. (OTC BB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, announced today that the first fifty percent (40 of 80) of melanoma subjects have been treated in its Phase 2 clinical trial of PV-10. Evaluation of new subjects continues at the trial's active centers in Adelaide, Brisbane and Sydney, Australia, as well as at M.D. Anderson, St. Luke's and the California Pacific Medical Center in the United States. The 40th subject was treated at the Royal Adelaide Hospital in Australia.
"Enrollment of the fortieth subject represents another significant milestone for Provectus Pharmaceuticals. With fifty percent of the subjects in the Phase 2 melanoma clinical trial already treated, we can continue to gather the data necessary to explore regulatory approval," said Craig Dees, Ph.D., CEO of Provectus. "With the recent addition of several more centers to the study we expect enrollment of the second half of subjects to continue at an accelerated pace."
Dees added, "As noted by Professor John Thompson, MD during his presentation at the "Perspectives in Melanoma XII" conference in The Hague, initial safety results from our expanded Phase 2 clinical trial of PV-10 for metastatic melanoma are also consistent with the Phase 1 safety profile. With the opportunity to treat lesions more than once in the Phase 2 study, we expect to improve upon the exceptional response noted in Phase 1. As we gather the results of the Phase 2 findings from these 40 subjects, our clinical trials team and respective regulatory authorities will consult to evaluate the potential for accelerated approval."
A further update on the study status is planned for the Sixth International Symposium on Melanoma, in mid-March 2009 in New York City. Safety data from the first 40 subjects, and interim efficacy data from the first 20 subjects, it expected to be presented at this meeting.
Provectus Pharmaceuticals' PV-10 has been granted orphan drug designation from the FDA for its metastatic melanoma indication. Provectus began phase 2 testing of PV-10 in late 2007, aiming to assess PV-10 chemoablation in 80 subjects with Stage III or IV metastatic melanoma, and announced in July that it had reached the first interim study milestone with the twentieth subject treated. According to the American Cancer Society, more than 62,000 people are expected to be diagnosed in the US in 2008 with melanoma, the most serious form of skin cancer, leading to over 8,000 deaths this year.
About ProvectusPharmaceuticals, 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.
