KNOXVILLE, Tenn.--Provectus Pharmaceuticals, Inc. (OTCBB: PVCT) announced preliminary results of its Phase 1 clinical trial of Provecta for the treatment of metastatic melanoma, the most aggressive form of skin cancer. Provecta demonstrated minimal side effects, significant efficacy and bystander effect on melanoma tumors in stage III patients. The study evaluated safety and efficacy of Provecta in a total of 20 subjects at two sites in Australia.
In the study, Provecta was injected once into one to twenty tumors in each subject. In addition to these treated tumors, an additional one to three tumors were left untreated in each subject to allow assessment of a potential "bystander effect" resulting from immune system response to tumor treatment. A total of 114 tumors were injected and 39 bystander tumors were observed in the study. Subjects were followed for 4 to 27 weeks. Study treatments were well tolerated and elicited minimal side effects, the most common being mild to moderate pain at the injection site.
Results for all evaluable tumors were tabulated using the RECIST (Response Evaluation Criteria in Solid Tumors) approach, which objectively grades response for each subject based on change in the sum of the longest diameter for each of the subject's tumors vs. baseline. Subject outcome was scored in terms of complete response (CR -- complete tumor disappearance or negative histopathology), partial response (PR -- 30% or more tumor shrinkage), stable disease (SD -- 29% shrinkage to 20% growth), and progressive disease (PD -- greater than 20% growth).
At final evaluation after injection with a single dose of Provecta, the following results were obtained: 20% of subjects achieved CR of their injected tumors, 20% achieved PR, 35% achieved SD and 25% achieved PD, corresponding to an objective response (CR+PR) in 40% of subjects and local disease control (CR+PR+SD) in 75% of subjects. Among those subjects achieving an objective response of their treated tumors, 25% achieved an objective response of their untreated bystander tumors, and 100% exhibited disease control in their bystander tumors. In contrast, for those subjects failing to achieve an objective response of their treated tumors, only 8% achieved an objective response of their bystander tumors, and 92% exhibited progressive disease in their bystander tumors. These differences in response of bystander lesions as a function of response of target lesions were statistically significant and support the occurrence of a bystander effect in subjects whose target lesions have been responsive to PV-10 chemoablation.
Craig Dees, Ph.D., Chief Executive Officer of Provectus stated, "While full analysis of our phase 1 data is yet to be completed and will be reported by other means, the significance of these top line numbers is compelling and serves to illustrate the unique properties of Provecta. Additionally, they reinforce the confidence level we've had since we first witnessed the effects of this drug for the treatment of melanoma. These results have motivated us to put forth an aggressive clinical plan designed to drive toward approval of Provecta for this devastating disease." Dees continued, "The response from the body's own immune system to those tumors that were left untreated makes our novel approach to treating the disease that much more attractive."
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