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FDA suspends Antigenics’ cancer vaccine trials

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Antigenics Inc. said on Wednesday that U.S. regulators suspended late-stage clinical trials of the company’s cancer vaccine and requested more information about the product before the company can proceed.

Antigenics said safety of the Oncophage vaccine was not an issue in discussions with the U.S. Food and Drug Administration, and patients already enrolled in phase III trials could continue with their course of treatment. Oncophage is derived from an individual patient’s own tumor, and is believed to be therefore more effective in “re-programming” the immune system to attack the cancer without side effects.The company said just two weeks ago that the vaccine significantly improved survival in 52% of patients with advanced colon cancer who responded to the drug. Antigenics said on August 18 that all 15 of the colon cancer patients whose immune systems responded to Oncophage were alive 2 years after the treatment, while only half of the patients who did not respond to the vaccine were alive. The New York company is also developing Oncophage to treat pancreatic cancer, kidney cancer, and metastatic melanoma. Preliminary results from phase III trials in kidney cancer were expected later this year. (Source: Reuters Health: September 3, 2003: Oncolink)

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Posted On: 5 September, 2003
Modified On: 3 December, 2013

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