OncoSec doses first patients in phase II Merkel cell carcinoma study
OncoSec Medical has treated several patients in an open-label, phase II clinical trial evaluating OncoSec's OMS (OncoSec Medical System) ElectroImmunotherapy for the treatment of Merkel cell carcinoma (MCC).
OMS ElectroImmunotherapy delivers a DNA-based cytokine coded for the immune stimulating agent interleukin-12, or DNA IL-12. It applies short electric impulses to the tumor, causing pores to open in the membrane of cancer cells that significantly increases DNA IL-12 uptake into these cells.
A total of up to 15 patients with local and distant Merkel cell carcinoma will be enrolled in this phase II, single-arm, multi-center study. The trial is designed to assess the clinical and biologic effects of increased local expression of IL-12 protein in the tumor microenvironment following treatment with OMS ElectroImmunotherapy. It is anticipated that marked local expression of IL-12 in the tumor will induce an immunologic response in the tumor microenvironment, which may result in clinical benefit for the patient.
"We were impressed by the results of the phase I study in malignant melanoma patients and strongly believe that OMS ElectroImmunotherapy will be especially effective in an immunogenic cancer such as Merkel cell carcinoma," said Dr. Shailender Bhatia, principal investigator at the University of Washington.
Punit Dhillon, president and CEO of OncoSec, added, “Patients with this rare and deadly skin cancer have few treatment options. This new clinical study is the only active immunotherapy trial that is focused specifically on this disease.”
Investigators at the University of Washington, a leader in the treatment of Merkel cell carcinoma, have received Investigational Review Board (IRB) approval and will continue recruitment for this clinical trial as the lead enrollment center. Several patients have been enrolled, with the first patient successfully completing treatment on Jan. 6, 2012. Doses have been administered by physicians at the University of Washington and Seattle Cancer Care Alliance in conjunction with the Fred Hutchinson Cancer Center.