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Oncophage Phase III Study To Continue After Interim Analysis of Results
The trial, taking place at 132 centers worldwide and involving more than 650 patients, is believed to be the most extensive study of adjuvant therapy in patients with RCC to date, as well as the largest clinical trial of any patient-specific treatment tested.
"We are most encouraged and pleased by the DMC's recommendations. Antigenics hopes to bring this treatment to RCC patients in the near future," said Garo H. Armen, PhD, chairman and CEO of Antigenics.
The randomized, two-arm study is evaluating the effect of Oncophage vaccination on recurrence-free survival in renal cell carcinoma patients at high risk of recurrence. Patients in the trial either receive nephrectomy (kidney removal) followed by observation, which is the current standard of care, or nephrectomy followed by Oncophage treatment, which consists of a series of therapeutic vaccines administered on an outpatient basis over the course of several weeks.
Derived from each individual's tumor, Oncophage contains the 'antigenic fingerprint' of the patient's particular cancer, and is designed to reprogram the body's immune system to target only cancer cells bearing this fingerprint. Oncophage is intended to leave healthy tissue unaffected and limit the debilitating side effects associated with traditional cancer treatments such as chemotherapy and radiation therapy. Oncophage has been granted fast track and orphan drug designations from the US Food and Drug Administration in both metastatic melanoma and renal cell carcinoma.
About Renal Cell Carcinoma
Renal cell carcinoma is the most common type of kidney cancer, accounting for about 85 percent of all kidney tumors. Kidney cancer affects roughly 31,000 people in the United States each year, and about 12,000 people will die from the disease. The current standard of care for patients with renal cell carcinoma consists of a nephrectomy, followed by observation.
Source: Antigenics Inc.