San Diego-based OncoSec Medical Inc. among those who are looking at novel approaches.

Melanoma is the most serious form of skin cancer. If recognized and treated early, it is almost always curable, but if not, the cancer can advance and spread to other parts of the body-in a process called metastasis-where it becomes hard to treat and potentially fatal. While not the most common skin cancer, melanoma causes the most fatalities. The American Cancer Society estimates that about 123,000 new cases of melanoma in the US are diagnosed every year, resulting in approximately 10,000 deaths. Currently, there are few treatment options for patients with late-stage metastatic disease that can extend survival.

A San Diego-based company, OncoSec Medical Inc., is among those who are looking at novel approaches. At a recent scientific meeting (the 6th World Meeting of Interdisciplinary Melanoma/Skin Care Centres & 8th EADO Congress), the company announced positive results from an ongoing trial investigating its own proprietary treatment in metastatic melanoma patients.

OncoSec's treatment, known as ImmunoPulse, hinges on two simple facts: First, when a small, localized electric current is administered in the vicinity of a tumor-a process called electroporation-tiny holes or pores temporarily open on the surface of the tumor's cancer cells. Second, during the interval when those pores are open, a drug can be absorbed by the cancer cells at effective doses much lower than normal. OncoSec has chosen to use a specific drug in tandem with its treatment-DNA IL-12-which is believed capable of stimulating a patient's immune system into attacking cancer cells while sparing healthy normal tissue.

At the time of the new preliminary interim analysis, 13 subjects were evaluable on the 39th day, nine on the 90th day and two on the 180th day. Each patient was treated with DNA IL-12 and underwent electroporation. By the 39th day, 95 percent of treated lesions showed some response to the treatment; as measured on the 90th day and again on the 180th day, all treated lesions showed some response to the treatment. Analysis of the safety data for the patients appeared to confirm that the use of DNA IL-12 with electroporation is safe and well-tolerated. Furthermore, the analysis provided evidence of a distant lesion response, which is the intent of this type of immunotherapy treatment. Specifically, the two patients evaluated at 180 days have shown what researchers call "stable disease" (meaning their cancer is neither decreasing nor increasing) and "complete response" (the disappearance of all outward signs of cancer, aka complete remission).

These study findings, while very preliminary, indicate a potential role for OncoSec's treatment as a safe and effective option for treating melanoma. Further results from the study will strengthen our understanding of the long-term effects of the treatment, perhaps leading to a new era for those with melanoma.