OncoSec Doses 1st Trial Patient for CTCL Treatment

San Diego, Calif., based biotechnology company OncoSec Medical Inc is announcing that they have dosed their first patient in a Phase II clinical trial evaluating their OMS ElectroImmunotherapy for the treatment of cutaneous T-cell lymphoma (CTCL).

OMS ElectroImmunotherapy delivers a DNA-based cytokine coded for the immune stimulating agent interleukin-12 (DNA IL-12). The OncoSec Medical System (OMS) then applies short electric impulses to the tumor. The result is to cause the pores to open in the membrane of cancer cells, creating substantial uptake of DNA IL-12 into these cells.

The company hopes to enroll a total of 27 patients with CTCL in this single-arm, open-label multi-center Phase II study. The primary endpoint will be to assess local and distant response rates following treatment of CTCL lesions (in either mycosis fungoides or Sezary Syndrome patients).

One treatment cycle will consist of three treatments applied to up to four lesions on days one, five and eight with a maximum dose of 3.0 mg DNA IL-12 per treatment cycle.

At three months, patients with stable disease or better will be eligible to be given a second treatment cycle. Additional treatment cycles at six, nine and 12 months can be applied if there is no evidence of disease progression or intolerability of the treatment, with a maximum of four cycles.

After one year, patients will be followed for up to five years for the sake of safety.

"The initiation of this study will mark the first time patients suffering from cutaneous T-cell lymphoma will be treated with an immunotherapy delivered using electroporation," said OncoSec President and CEO Punit Dhillon. "We are excited to be working with Dr. Weiyun Ai and a leading academic institution, UCSF, in this study."