45 percent of Treated Lesions Demonstrated a Durable Response Of At Least 6 Months
SAN DIEGO – March 25, 2013 – OncoSec Medical Inc. (OTCQB: ONCS) – a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumors – announced positive, durable response results in an update on interim data from its Phase II metastatic melanoma trial. The data was presented at the HemOnc Today Melanoma and Cutaneous Malignancies Conference on March 22, in New York City.
In this analysis, all melanoma lesions that demonstrated at least a partial or complete response (PR or CR) to treatment with ImmunoPulse were followed, to determine durable response. Sixty-eight percent and fourty-five percent of treated lesions demonstrated a durable response at three and six months, respectively.
Punit Dhillon, President and CEO said, “We are encouraged by this updated data from the interim analysis, especially in light of recent announcements related to durability of response for other intralesional therapies. This data not only shows that ImmunoPulse can effectively eliminate the targeted tumors but also that our treatment can have a lasting effect on those tumors.”
Adil Daud, MD – the study’s principal investigator at the University of California San Francisco – said, “This data demonstrates that the lesions we have selected for treatment are responding well to the therapy and that the ImmunoPulse can trigger a lasting immune response, against the treated lesion. It is now important for us to see if this local immune reaction can result in a more widespread response against untreated lesions.”
These interim results reinforce previously announced Phase I data demonstrating that ImmunoPulse therapy is safe and well tolerated, as well as producing robust objective response rates, in patients with metastatic melanoma. OncoSec expects to complete enrollment of approximately 25 patients in total, in Q2 2013, with final analysis anticipated in Q4 2013.
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.