Provectus Biopharmaceuticals, Inc recently announced it has completed development of its protocol for phase Ib/II testing in patients with stage IV melanoma.
Peter Culpepper, CPA, MBA
Provectus Biopharmaceuticals, Inc recently announced it has completed development of its protocol for phase Ib/II testing in patients with stage IV melanoma, a clinical trial that will examine the investigational cancer drug PV-10 in conjunction with the immunotherapy, pembrolizumab.
PV-10 is a novel investigational drug and has already entered phase III of another clinical trial in patients with stage III melanoma. Researchers have advanced this potential cancer treatment through previous clinical testing with systematic inhibitors of immune system down-regulation, such as antiCTLA-4, PD-1, and PD-L1 immune checkpoint inhibiting antibodies.1
Essentially, PV-10 is distributed through injection into solid tumors and is most prominently concentrated for use among melanoma, breast cancer, and liver cancer.2
"This study is both scientifically and commercially important to Provectus. Scientifically, combination therapy in cancer treatment is a rapidly maturing area, where rational combination of agents is replacing the empirical approaches of the past,” said Peter Culpepper, CPA, MBA, Provectus CFO and COO, in a statement.1“Commercially, this is the second of three steps that we hope will significantly strengthen our hand in negotiating a co-development transaction with an immunotherapy-focused partner.”
“Our joint patent with Pfizer was the first; this study is the second; and the third is our immune mechanism of action clinical study, which is under way at the Moffitt Cancer Center and which has completed recruitment,” Culpepper added.
The phase Ib/II study will comprise a “modest-sized single-arm phase Ib component” of 24 participants with safety and efficacy endpoints, which may provide the base for an expanded randomized sample in the phase II component.1The Provectus team is looking to recruit a randomized sample of patients with stage IV melanoma for whom surgery is not recommended. The clinical trial will, however, exclude patients with untreated or clinically active melanoma brain metastasis who have had prior cancer treatment or who have concurrent illnesses.3
Participants of the trial will receive PV-10 to their injectable cutaneous and subcutaneous lesions as well as subsequent readministration of PV-10 at 3-week intervals throughout the treatment phase of the study to any lesions that have either not yet been injected with the drug or have not yet shown signs of change.3The PV-10 injection period would continue for up to 13 weeks after the first dose of the cancer drug. Additionally, patients will receive pembrolizumab treatments on the same 3-week basis for potentially as long as 24 months.3
Eric Wachter, PhD, CTO of Provectus, explained that the team would employ an adaptive design for powering phase II based upon the preliminary results from phase I, a phase that would require 120 participants who fit the study’s eligibility requirements.1
Previous findings demonstrated positive correlations between PV-10 and pembrolizumab. In one instance, clinical findings from 2014 demonstrated that immunological effects of tumor ablation with PV-10 might have been complimentary to immune checkpoint inhibition.
According to a Provectus press release, “Companion preclinical testing of PV-10 in murine models of melanoma, also reported last year, showed that the therapeutic effects of PV-10 and immune checkpoint inhibition are increased when the two are used in combination.”1