provectus biopharmaceutica-a (PVCT) Key Developments
Provectus Biopharmaceuticals, Inc. Extends for Additional 60 Days Memorandum of Understanding with Sinopharm-China State Institute of Pharmaceutical Industry, Sinopharm a-Think Pharmaceutical
May 18 15
Provectus Biopharmaceuticals, Inc. announced that it had extended for an additional 60 days its Memorandum of Understanding with Sinopharm-China State Institute of Pharmaceutical Industry and Sinopharm A-THINK Pharmaceutical Co. Ltd. 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.
Provectus Biopharmaceuticals Announces Poster Presentation on PV-10 Clinical Data from Phase 1 Study for Cancers of the Liver
May 14 15
Provectus Biopharmaceuticals, Inc. announced that the abstract titled, "Phase 1 Study of PV-10 for Chemoablation of Hepatocellular Cancer and Cancer Metastatic to the Liver," to be presented at the European Society for Medical Oncology’s 17th World Congress on Gastrointestinal Cancer, is scheduled for July 2, 2015 from 10:30 to 11:00 a.m. and 4:55 to 5:25 p.m. local time. Sanjiv S. Agarwala, MD, of St. Luke's University Hospital and Health Network, Bethlehem, PA, will be the presenter.
Provectus Biopharmaceuticals, Inc. - Special Call
Apr 29 15
To discuss on quarterly business update and provide a business update on PV-10 and PH-10
Provectus Biopharmaceuticals, Inc. Receive Patent for Use of PV-10 in Combination with Systemic Immunotherapy Agents in Treatment of Cancer
Apr 20 15
Provectus Biopharmaceuticals, Inc. announced that it has received from the US Patent and Trademark Office a Notice of Allowance for a joint patent
application made with Pfizer, Inc. The patent will protect use of PV-10 in combination with certain other types of drugs in the treatment of melanoma and cancers of the liver. The allowed claims cover use of PV-10 in combination with systemic inhibitors of immune system down-regulation, such as anti-CTLA-4, PD-1 and PD-L1 antibodies, along with enhancers of immune system up-regulation, such as IL-2 and interferon-gamma. Pre-clinical testing of PV-10 used in combination with these important classes of drugs demonstrated potential importance for treatment of advanced cancers.
Provectus Biopharmaceuticals, Inc. Opens Enrollment of Patients for its Phase 3 International FDA Comparative Clinical Trial of PV-10 for Melanoma
Apr 16 15
Provectus Biopharmaceuticals, Inc. announced that it enters phase 3 and has opened enrollment of patients for its phase 3 international FDA comparative clinical trial of PV-10 for melanoma. The company is seeking 225 patients and enrollment has begun at St. Luke's University Hospital and Health Network, Bethlehem, PA, the first study site to be opened, with additional sites to be added in the coming weeks and months. The study is an international multicenter, open-label, randomized controlled trial (RCT) of single-agent intralesional PV-10 versus systemic chemotherapy with dacarbazine (DTIC) or temozolomide (TMZ) to assess treatment of locally advanced cutaneous melanoma in patients who are BRAF V600 wild-type and have failed or are not otherwise candidates for ipilimumab or another immune checkpoint inhibitor. Subjects in the comparator arm will receive the Investigator's choice of dacarbazine or temozolomide as determined by Investigator preference and/or local availability of the agent. Effectiveness will be assessed by comparison of progression-free survival (PFS) between all intent-to-treat (ITT) subjects in the two study treatment arms. The Primary Outcome Measure is progression-free survival (PFS) to be assessed every twelve weeks up to eighteen months. The Secondary Outcome Measures include complete response rate (CRR) and its duration (to be assessed every twelve weeks up to eighteen months); and Overall survival (OS) to be assessed every twelve weeks up to eighteen months. Safety and tolerability will be assessed by monitoring the frequency, duration, severity and attribution of adverse events and evaluating changes in laboratory values and vital signs.