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June 3, 2014
08:24 EDTPVCTProvectus Pharmaceuticals presents PV-10 data at ASCO
Provectus Biopharmaceuticals announced that data on its investigational agent PV-10 for intralesional treatment of solid tumors were featured in two presentations in the Poster Highlights Session, Melanoma/Skin Cancers, on June 2 during the American Society of Clinical Oncology annual meeting in Chicago, IL. In the phase 2 PV-10 trial, when all existing lesions were injected with PV-10, tumors were no longer detectable in 50% of the patients. This subgroup analysis supports the potential of PV-10 as a single agent and provides a rationale for a PV-10 phase 3 randomized controlled trial in locally advanced melanoma patients. This phase 3 randomized controlled trial of PV-10 in patients with unresectable locally advanced cutaneous melanoma will assess response to PV-10 vs that of systemic chemotherapy in patients who have disease limited to cutaneous and subcutaneous sites and who have failed or are ineligible for systemic immunotherapy. Progression-free survival and complete response rate will be assessed using standard criteria. Overall survival and exploratory assessment of patient reported outcomes related to lesion pain and other melanoma symptoms will also be assessed. The study is expected to commence this year, and will allow for interim assessment when 50% of the required events have occurred. Eric Wachter, Ph.D., Chief Technology Officer of Provectus, said "Our focus this year will be initiation of the phase 3 randomized controlled trial. We also expect to begin the more exploratory combinatorial work that potentially addresses the needs of patients with more advanced metastatic disease."
News For PVCT From The Last 14 Days
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September 29, 2015
10:28 EDTPVCTProvectus to host special shareholder meeting
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06:13 EDTPVCTProvectus' intralesional RB decrease tumour burden in animal models
Provectus Biopharmaceuticals reported that the Journal of Clinical and Cellular Immunology has published a paper titled, "The Potential of Intralesional Rose Bengal to Stimulate T-Cell Mediated Anti-Tumor Responses." Authors state that their "article serves to evaluate the potential of intralesional rose bengal, or RB, to stimulate T-cell mediated anti-tumor responses in in-vitro, pre-clinical, and clinical studies." The review covers findings in both animal models and human clinical trials covering the use of intralesional RB in the treatment of: melanoma, breast cancer, ovarian cancer, gastric cancer and sarcoma. They conclude, "Our current research is establishing the role of RB in generating anti-tumor immune responses in gastrointestinal cancer and liver metastases. Decrease in tumor burden and stimulation of an immune response with PV-10 has been demonstrated in animal models of metastasis, and correlations of these responses in clinical studies is consistent with such results. That PV-10 treatment can potentially increase circulating cytotoxic T-cells, even in patients who were previously treated with immune-activating checkpoint blockade, supports the possibility that RB induced cytotoxicity may activate T-cells that are responsible for the bystander effect on untreated lesions. As such, intralesional therapy with RB may be a promising new mode of therapy to stimulate T-cell mediated anti-tumor immune responses."
September 23, 2015
08:50 EDTPVCTProvectus initiates Phase 1b/2 trial of PV-10 combo with Pembrolizumab
Provectus Biopharmaceuticals (PVCT) announced it has completed development of the protocol for Phase1b/2 testing of its investigational cancer drug PV-10 in combination with pembrolizumab in patients with Stage IV melanoma. Pembrolizumab, also known as Keytruda, a product of Merck (MRK), is an immune checkpoint inhibitor approved for treatment of patients with advanced or unresectable melanoma. PV-10 is Provectus's novel investigational drug for cancer that is injected into solid tumors. It is currently undergoing Phase 3 clinical testing in patients with Stage III melanoma. Clinical testing under the new Phase 1b/2 protocol is expected to commence before the end of the year. The FDA granted accelerated approval to pembrolizumab in September 2014, making it the first FDA-approved anti-PD-1 immune checkpoint inhibitor. Because pembrolizumab is already FDA-approved, Provectus can commence this study with or without assistance of a partner.

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