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:
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An Objective Response Rate (OR) of 50% in subjects' target lesions
(25% Complete Response and 25% Partial Response);
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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;
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Response rates were analyzed by disease stage for the first time:
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Stage III subjects experienced a substantially higher response
rate (58% OR and 81% disease control) versus Stage IV subjects
(22% and 33%, respectively);
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Similar trends were noted in response metrics for bystander
lesions between these two subpopulations;
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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."