Provectus Pharmaceuticals, Inc. (OTCBB: PVCT, http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, has 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.
“Chemoablation of metastatic melanoma with rose bengal (PV-10)”
Key Data From the First 40 Subjects in the Phase 2 Study Include:
- Objective Response of PV-10 injected lesions was achieved in 61% of subjects, with a Complete Response (“CR”) in 33% of subjects and locoregional disease control (Stable Disease, “SD”, or better) in 79% of subjects;
- An OR was achieved in untreated bystander lesions in 43% of subjects having an evaluable bystander lesion at baseline;
- Mean Progression Free Survival (“PFS”) was 8.5 months for all subjects, while the OR cohort had a significantly longer PFS estimated to be at least 11.1 months vs. 2.8 months or less for SD or Progressive Disease (“PD”) subjects;
- Adverse Experiences during the study interval were generally mild to moderate, locoregional and transient, with no deaths or life-threatening experiences attributable to PV-10.
Dr. Sanjiv Agarwala, Chief of Medical Oncology and Hematology at St. Luke’s Hospital and Health Network in Bethlehem, PA, and Principal Investigator for Provectus’s Phase 2 PV-10 trial site at St. Luke’s, said, “These data are very exciting in many respects, with a lengthy Progression Free Survival being particularly encouraging. Since subjects were only observed for 12 months, it wasn’t possible to document time to progression in the substantial fraction of subjects achieving a highly durable response. Nonetheless, the marked difference in estimated PFS among PV-10 responsive subjects versus those who failed to respond bodes very well for responsive subjects, while allowing non-responsive subjects to commence alternate therapies without significant delay. With additional data being tabulated since the abstract was submitted, including key data on outcome of untreated visceral lesions, we should have very interesting supplemental information for presentation at the conference.”
Craig Dees, Ph.D., CEO of Provectus said, “The results of Phase 2 clinical trial are gratifying, providing additional validation of our hypothesis that PV-10 is a safe and effective treatment for metastatic melanoma. These data, combined with the results of our recent End-of-Phase 2 meeting with the FDA, provide greater confidence that we are getting closer to a viable treatment for this deadly disease. The FDA meeting provided us the guidance to design the protocol for a pivotal Phase 3 randomized controlled study suitable for Special Protocol Assessment (“SPA”). An SPA would affirm that our Phase 3 clinical trial design, endpoints, sample size, planned conduct and statistical analyses are acceptable for regulatory approval, defining the regulatory pathway for PV-10 as a treatment for metastatic melanoma. We look forward to implementing the next steps in our clinical development, bringing us closer to commercialization of PV-10.”
Provectus Pharmaceuticals, Inc.