OncoSec Medical (OTCBB:ONCS) said Monday it has dosed a first patient and initiated a phase II clinical trial testing the OMS ElectroImmunotherapy treatment for cutaneous T-cell lymphoma.
The cancer therapy company, which develops OncoSec Medical System (OMS) ElectroOncology therapies to treat solid tumours, said it received investigational review board approval at the University of California San Francisco Helen Diller Family Comprehensive Cancer Center (UCSF) for the study.
UCSF investigators are actively recruiting for this clinical trial now, with a total of up to 27 patients with cutaneous T-cell lymphoma, a type of skin cancer, to be enrolled.
The main goal of the single-arm, open-label and multi-center study will be to assess the local and distant response rate following treatment of cancerous lesions.
OncoSec's locally administered and potentially systemic ElectroImmunotherapy program works by using the OMS electroporation system to deliver a DNA-based immunotherapy, known as DNA IL-12.
The electroporation system applies short electric pulses to cells, causing the opening of pores in the cell membrane, and allowing for the efficient and safe delivery of immunotherapy or chemotherapy agents to treat a range of solid tumour cancers.
The company noted the OMS electroporation system has been proven to enhance cellular uptake, effectively treating cancerous cells while sparing surrounding healthy tissue, cutting through the toxic side effects of current available treatment options like chemotherapy and radiation.
OncoSec's ElectroImmunotherapy program is currently being developed in phase II studies for the treatment of three rare skin cancer indications - metastatic melanoma, Merkel cell carcinoma and cutaneous T-cell lymphoma.
For the cutaneous T-cell lymphoma trial, 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 milligrams DNA IL-12 per cycle.
Patients with stable disease or better at three months will be eligible to receive a second treatment cycle, the company said, with additional treatment cycles possible at six, nine and 12 months of there is no evidence of disease progression. A maximum of four treatment cycles is allowed.
At 12 months, patients will be moved to the follow-up phase of the study, to be evaluated for up to five years for safety.
The first patient has already been enrolled and successfully completed the first treatment cycle, OncoSec noted.
"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 president and CEO of OncoSec, Punit Dhillon.
"We are excited to be working with Dr. Weiyun Ai and a leading academic institution, UCSF, in this study."
Phase I data using OMS ElectroImmunotherapy to treat malignant melanoma showed that this therapy was safe and well tolerated, the company noted.
In addition, 53 per cent of patients with distant metastatic lesions showed an objective response, with 16 per cent of these patients having a complete response to the treatment.
Dr. Weiyun Ai added: "There exists a substantial need for novel treatments for cutaneous T-cell lymphoma. The role of electroporation in enhancing the efficiency and/or the tolerability of various agents, such as DNA IL-12, can be delivered to patients is well worth studying."
Last month, OncoSec said that enrollment for its ongoing phase II metastatic melanoma trial testing the company's OMS ElectroImmunotherapy was 50 per cent complete. A total of up to 25 patients with stage III or IV cutaneous and in-transit metastatic melanoma will be enrolled in the phase II study.
Based on safety data so far, no grade three or higher adverse events related to the treatment have been reported, OncoSec said, "and most reported adverse events were treatable and transient."
The preliminary results were presented by principal investigator, Dr. Adil Daud, at the second European Post-Chicago Melanoma meeting in Munich, Germany.