Provectus Pharmaceuticals (OTC-BB: PVCT) Continues to Progress through Trials
Provectus Pharmaceuticals, Inc. (PVCT), which is developing a cancer therapy in the same market as companies like Genta Incorporated (GETA) and Dendreon Corporation (DNDN), has made significant progress over the past few months by first completing its Phase II PV-10 trials and then reporting the results at the industry’s ASCO conference in Chicago, IL in June.
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Provectus Reports Successful End-of-Phase II Meeting with FDA
On April 29, 2010, Provectus Pharmaceuticals, Inc. announced that it has held an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to seek consensus on clinical program scope and endpoints for licensure of PV-10 for metastatic melanoma. The meeting was held at the Agency’s White Oak Campus in Silver Spring, MD.
Craig Dees, Ph.D., CEO of Provectus said, “This meeting provided an opportunity to thoroughly review the clinical data we have amassed through our Phase 1 and Phase 2 studies with PV-10. As expected, the meeting was fruitful and provided a forum for discussion of appropriate endpoints for assessment of clinical benefit of PV-10 in melanoma patients and for definition of the pathway leading to licensure.”
Dr. Dees continued, “Based on consultation with senior Agency officials during this meeting, we expect to hold a second end-of-Phase 2 meeting in the coming months to finalize design of a pivotal Phase 3 randomized controlled study suitable for Special Protocol Assessment (SPA).”
Dr. Dees concluded, “We are fortunate that our capital resources afford flexibility to consider pursuing both the conventional Phase 3 pathway, as well as an accelerated route to licensure. While we believe the Phase 3 with an SPA represents an industry standard path to approval, we believe the door may still be open for accelerated approval.”
Provectus Reports Positive Phase II Trial Data at ASCO Conference
On May 21, 2010, Provectus Pharmaceuticals, Inc. followed up with investors by presenting at the ASCO conference in Chicago, IL. At the conference, the company announced further positive data on the first forty subjects in its Phase 2 clinical trial of PV-10 for metastatic melanoma, with an objective response (“OR”) observed in 61% of subjects and a mean Progression Free Survival (“PFS”) of at least 11.1 months among those subjects achieving an OR.
These data were included in Abstract #8534, entitled “Chemoablation of metastatic melanoma with rose bengal (PV-10)”, to be presented by Dr. Sanjiv Agarwala at the American Society of Clinical Oncology 2010 Annual Meeting, on Sunday, June 6, 2010 in General Poster Session #209, Melanoma/Skin Cancers.
Conclusions
Provectus Pharmaceuticals, Inc. (OTC-BB: PVCT) is rapidly progressing through its PV-10 clinical trials, as its drug continues to show both safety and efficacy. The company is now focused on setting up and completing a Phase III trial, while searching for a development partner. And both of these events could lead to strong catalysts to propel the stock higher.
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