Tuesday, 20 March 2012

OncoSec Medical on track to meet or exceed 2012 goals, says CEO

Cancer therapy company OncoSec Medical (OTCBB:ONCS) has made significant progress recently, and is on track to meet or exceed its targeted 2012 milestones, says CEO Punit Dhillon in an interview with Proactivinvestors.
Last week, the company initiated two additional clinical sites for its phase two metastatic melanoma trial, testing its OMS ElectroImmunotherapy treatment.
The company said the John Wayne Cancer Institute in Santa Monica, California, and the Lakeland Comprehensive Cancer Center in Lakeland, Florida have been initiated as enrolling sites, with investigators now screening patients for the phase two metastatic melanoma study. OncoSec now has a total of three clinical centers for the study, with the University of California San Francisco, and is looking to add three more shortly.
OncoSec uses its OMS electroporation delivery system that 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 OMS electroporation system has 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.
The company outlined a clinical development plan for this year for its locally administered and potentially systemic ElectroImmunotherapy program, which uses the OMS system to deliver a DNA-based immunotherapy, known as DNA IL-12.
The goal was to launch three phase 2 based ElectroImmunotherapy trials for rare skin cancer indications, two of which have already been started.
Dhillon says these two trials, for metastatic melanoma and merkel cell carcinoma, are now open for enrollment, with enrollment numbers so far "extremely encouraging".
The company is confident it will exceed enrollment targets, says its CEO, with 25 patients targeted for the melanoma study and 15 planned for the Merkel cell carcinoma trial.
In fact, the company's trial for Merkel cell carcinoma, which is three times more deadly than melanoma, was featured in a news segment by a local NBC affiliate in Seattle, Washington, KIRO News 7, which looked at the work being done by OncoSec in collaboration with researchers at the University of Washington and Fred Hutchinson Cancer Center.
Merkel cell carcinoma is a rare and highly aggressive form of skin cancer with a 40 percent mortality rate and about 1,500 new cases each year.
The company's third phase 2 study for cutaneous t-cell lymphoma is on track to launch in the next 30 days, with the company looking to enroll 27 patients.
OncoSec is also on track to release data from these studies in the second half of this year.
The OMS ElectroImmunotherapy delivers DNA IL-12, which is designed to induce a local immune response against the treated cancerous tumour, while exploiting this response to initiate a global systemic response against untreated tumours in other areas of the body.
At the American Association of Dermatology conference in San Diego this month, Dhillon says he had the chance to meet up with key investigators from the trial, who were "surprised at the simplicity and ease of use" of the ElectroImmunotherapy system.
"We are very excited from the enthusiasm we received at the conference," Dhillon says.
"With the phase two trials, we would like to demonstrate that the treatment is simple and easy to administer, and can be a real alternative for very deadly diseases.
"Today's existing therapies like chemo and radiation have a high degree of toxicity and safety issues, whereas ElectroImmunotherapy provides the same type of systemic response with a simpler, and more targeted therapy."
Dhillon says the phase two data is meant to build on the "robust" phase one trial data and hone in on more items - for example, the company has built in additional treatment courses for the phase two study, whereas the phase one trial was built on a single treatment course.
"We hope to show the durable therapeutic effect of the ElectroImmunotherapy treatment from the phase two program."
In the phase two metastatic melanoma study, a total of up to 25 patients with stage three or four metastatic melanoma will be enrolled, designed to assess local and distant objective response following treatment, with a primary endpoint of 24 weeks.
One treatment cycle will consist of three treatments applied to up to four cancerous 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, the company said.
Phase 1 data using OMS ElectroImmunotherapy to treat malignant melanoma demonstrated that the treatment was safe and well tolerated. In addition, 53 percent of patients with distant metastatic lesions demonstrated an objective response, with 15 percent of these patients having a complete response to the treatment.
Melanoma is a 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.
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 around 10,000 deaths.
Melanoma originates in melanocytes, the cells which produce the pigment melanin that colors our skin, hair, and eyes. The majority of melanomas are black or brown, but often they can also be skin-colored, pink, red, purple, blue or white.

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