Provectus Pharmaceuticals, Inc. (OTCBB: PVCT, http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, announced that top-line final data from its phase 2 clinical trial of PV-10 for metastatic melanoma were presented at the 2nd European Post-Chicago Melanoma Meeting 2012, Interdisciplinary Global Conference on Developing New Treatments for Melanoma, on June 22, 2012, in Munich, Germany. The data were presented by Dr. Sanjiv Agarwala, M.D., a Principal Investigator for the PV-10 Phase 2 trial, and Chief of Medical Oncology and Hematology at St. Luke's Hospital and Health Network in Bethlehem, PA.
The new data, on response rate and progression free survival, corroborated previously presented preliminary data on these topics. Key final data from the 80 subjects in the Phase 2 study include:
- An Objective Response Rate (OR) of 50% in subjects' target lesions (25% Complete Response and 25% Partial Response);
- 70% disease control in these lesions (combined Complete, Partial and Stable Response subjects);
- 33% of subjects having an untreated bystander melanoma lesion achieved an OR in their bystander lesions while 50% achieved disease control in these lesions;
- Response rates were analyzed by disease stage for the first time:
- Stage III subjects experienced a substantially higher response rate (58% OR and 81% disease control) versus Stage IV subjects (22% and 33%, respectively);
- Similar trends were noted in response metrics for bystander lesions between these two subpopulations;
- Analysis of temporal data showed that Stage III subjects also experienced significantly greater mean Progression Free Survival (PFS) of at least 9.6 months, versus 3.1 months for Stage IV subjects. Median PFS for Stage III subjects was not reached during the 12-month study interval;
- Higher response rates were noted among “evaluable subjects” (subjects that continued in the study for at least 8 weeks, enabling their responses to PV-10 to be assessed).
The full presentation may be viewed on the Company's website at: http://www.pvct.com/news/PV-10_Second-PostASCO-22Jun2012.pdf
Dr. Eric Wachter, PhD, Chief Technical Officer of Provectus and Study Director for the clinical trial, noted that, “These preliminary analyses using final, fully validated study data confirm trends previously reported using preliminary data, and are also consistent with trends we observed in our earlier phase 1 trial. We are now completing full statistical analysis of the data, and expect to report these final results in September at ESMO 2012, the annual meeting of the European Society for Medical Oncology.”
Dr. Wachter also noted, “The increased response rates for evaluable subjects, for instance 58% objective response rate and 81% disease control of target lesions vs. 50% and 70% respectively for all subjects enrolled in the study, is expected since it eliminates the impact of 5 Stage III subjects and 6 Stage IV subjects whose disease at enrollment appears to have been rapidly deteriorating and presumably precluded them from deriving substantive benefit from treatment of only a portion of their expanding disease burden with PV-10. The relevance of this is that similar non-evaluable subjects are unlikely to be enrolled in our phase 3 trial.”
Dr. Agarwala, commenting on the reported data, stated, “These results are quite remarkable, confirming that a robust response can be achieved with PV-10, particularly in Stage III patients where it is possible to inject all or virtually all of the patient's melanoma lesions. While we were only able to treat patients using a limited dosing schedule in this study, many of them, nonetheless, achieved very good disease control or even complete remission, including a number of subjects who experienced favorable response in untreated skin or visceral lesions. This is very encouraging as we anticipate phase 3, where this same Stage III population will have the potential to receive additional benefit under a PV-10 treatment schedule that is well beyond that allowed in this study.”
Dr. Craig Dees, PhD, CEO of Provectus said, “We're gratified but not surprised at these results, following very careful and thorough validation of outcome data for all study participants. The response rate and PFS data presented by Dr. Agarwala underscore our selection of anticipated patient population and primary endpoint for our proposed Phase 3 clinical trial protocol of PV-10 for melanoma, and are supportive of our efforts to successfully complete Special Protocol Assessment with the U.S. Food and Drug Administration (FDA).”
Provectus Pharmaceuticals also expects PV-10 Phase 2 data to be featured in a peer-reviewed publication in upcoming months.
Provectus Pharmaceuticals, Inc.