About the Phase II ImmunoPulse Study
A total of up to 25 patients with stage III or IV cutaneous and in-transit metastatic melanoma will be enrolled in this Phase II, single-arm, open-label and multi-center study. The trial is designed to assess local and distant objective response, following treatment of cutaneous melanoma lesions with DNA IL-12 and electroporation, with a primary endpoint of 24 weeks. One treatment cycle will consist of three treatments applied to up to four lesions on days 1, 5 and 8, with a maximum dose of 1.5 mg DNA IL-12 per treatment cycle. At 12 months, patients will be moved to the follow-up phase of the study and will be followed for up to five years, for safety.
Melanoma is the most serious form of skin cancer. If it is recognized and treated early, it is almost always curable but, if it is not, the cancer can advance and spread to other parts of the body where it becomes hard to treat and can be fatal. While it is not the most common of the skin cancers, it causes the most deaths. The American Cancer Society estimates that, at present, about 123,000 new cases of melanoma in the US are diagnosed in a year; resulting in approximately 10,000 deaths. Melanoma originates in melanocytes: the cells that produce the pigment melanin that colors our skin, hair, and eyes. The majority of melanomas are black or brown but can also often be skin-colored, pink, red, purple, blue or white. Currently, there remain few treatment options for patients with late-stage metastatic disease that can extend survival for the broad population.
About OncoSec Medical Inc.
OncoSec Medical Inc. is a biopharmaceutical company developing its advanced-stage ImmunoPulse DNA
|SOURCE OncoSec Medical Incorporated|
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