Provectus Biopharmaceuticals' PV-10 Clinical Data on Melanoma Now Available for European Society for Medical Oncology 2014 Congress
Poster Presentation Scheduled for Sunday, September 28, 2014, From 12:45 To 1:45 pm
ESMO 2014 Congress in Madrid, Spain, Runs from September 26-30, 2014
Wednesday September 24, 2014
KNOXVILLE, Tenn.--(BUSINESS WIRE)--Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company ("Provectus"), announced today that the abstract entitled, "Subgroup efficacy in patients receiving intralesional rose bengal to all existing melanoma in phase II study PV-10-MM-02," to be presented at the European Society for Medical Oncology 2014 Congress, is now available at
https://www.webges.com/cslide/library/e … #9faD03sJ. [see below]
The ESMO 2014 Congress in Madrid, Spain, runs from September 26-30, 2014. This poster presentation will be held on Sunday, September 28, 2014, beginning at 12:45 pm local time, presented by Sanjiv S. Agarwala, MD, of St. Luke's Hospital and Health Network, Bethlehem, PA.
Dr. Craig Dees, PhD, CEO of Provectus, said, "We are very pleased that these subgroup data will be presented at ESMO this year, and we are glad that our principal investigator Dr. Agarwala will be available to discuss this work with attendees."
PV-10, a 10% solution of Rose Bengal that is currently being investigated as a potential cancer therapeutic, is designed for injection into solid tumors (intralesional administration).
The complete press release is available at www.pvct.com/pressrelease.html?article=20140924 on the Provectus website.
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Abstract
1120P - Subgroup efficacy in patients receiving intralesional rose bengal to all existing melanoma in phase II study PV-10-MM-02
Aim
The safety and efficacy of intralesional (IL) treatment of refractory cutaneous melanoma with rose bengal disodium (PV-10) was evaluated in an 80 patient (pt) international, multicenter, single arm phase II trial (NCT00521053).
Methods
Patients refractory to a median of 6 previous interventions with 6.3 cm median sum lesion diameter in biopsy-confirmed melanoma received PV-10 into up to 20 cutaneous and subcutaneous lesions up to 4 times over a 16-week period and were followed for 52 weeks. Best overall response rate (BORR) was assessed in up to 10 injected target lesions. Secondary endpoints included assessment of duration of response, BORR of untreated bystander lesions, overall survival and adverse events. Confidence intervals for response were based on the exact cumulative probabilities of the binomial distribution (95% confidence intervals).
Results
Overall, PV-10 was well tolerated and 41 of 80 ITT pts met the primary endpoint of objective response (CR + PR) in their injected target lesions (51% ORR CI 40-63%, 26% CR). In the subgroup of 28 pts who received PV-10 into all existing melanoma lesions, ORR was 71% (CI 51-87%) with 50% CR (CI 31-69%). In these pts plus 26 pts with uninjected disease limited to bystanders (i.e., 54 pts) CR was achieved in 232 of 363 injected lesions (64% CR): 121 lesions required a single injection for CR, 84 required 2 injections, 22 required 3 injections and 5 required 4 injections. Additionally, 10 of 28 uninjected bystander lesions achieved CR.
Conclusions
Recurrent locoregional melanoma can be a source of persistent morbidity, including disfigurement frequently accompanied with pain, ulceration, bleeding and infection. The high rate of symptom control in refractory patients, manifest in CR of injected lesions after minimal intervention, was the basis for a breakthrough therapy designation application to the US FDA based on the 28 patient “all treated” subgroup, and implications of the Agency's ruling on this application will be presented. Although the primary ablative effect is responsible for CR in injected tumors, durability of response and bystander response implicate an immunologic mechanism of action secondary to ablation.
Disclosure
J.M. Singer: Employee, stock ownership; E. Wachter: Employee, stock ownership. All other authors have declared no conflicts of interest. |
