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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."
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May 18, 2015
06:02 EDTPVCTProvectus extends for 60 days of MOU with Sinopharm-China, Sinoopharm a-THINK
Provectus announced that it had extended for an additional 60 days its Memorandum of Understanding with with Sinopharm-China State Institute of Pharmaceutical Industry and Sinopharm A-THINK Pharmaceutical. The extension was the only change to the agreement, and the MOU is now in force through July 15, 2015. The original MOU was signed in August 2014, and since then, the parties have sought to enter into a definitive licensing agreement, subject to additional negotiation, due diligence, and any required regulatory and corporate approvals. The original MOU was to be in effect for 90 days, and in November 2014 it was extended through May 16, 2015. Since the signing of the MOU, management of Provectus and senior personnel at Sinopharm-CSIPI and Sinopharm A-THINK have held numerous conference calls, have met face-to-face in both China and the US, and Chinese scientists on staff at Sinopharm have discussed in person PV-10 and its clinical results with the lead investigators at St. Luke’s University Hospital and Health Network and Moffitt Cancer Center.

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