Antigenics Asks European Regulators to Approve Oncophage for Kidney Cancer
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is that in patients with intermediate risk of cancer relapse, people on its drug stayed in remission for 4.2 years, compared with 2.5 years for patients who didn’t get it. The immune system wasn’t able to help ward off a relapse in patients with more aggressive forms, researchers have said.
If the company were forced to start over with another trial that prospectively looked only at intermediate-risk patients on Oncophage versus a placebo, it would take six to seven years and wouldn’t be practical, Armen told me earlier this year when I was with Bloomberg News.
Antigenics is one of the few companies still standing in the class of biotech companies aiming to stimulate the immune system against cancer. South San Francisco-based Cell Genesys pulled the plug on its GVAX treatment against prostate cancer recently, and Genitope failed in a large trial of patients with non-Hodgkin’s lymphoma. Seattle-based Dendreon (NASDAQ: DNDN) is still in the running with a trial of 500 men with prostate cancer, to see if its treatment can extend lives with minimal side effects.
The Antigenics treatment is different because it is designed to be personalized, made by slicing out a portion of a patient’s tumor. The tumor tissue is frozen and shipped to the Antigenics plant in Lexington, where it is chopped up, and key proteins filtered out. The treatment is shipped back to the doctor, then injected back into the patient to “teach” the immune system to spot the hallmarks of cancer cells and mount a defense against them. Patients usually get their personalized vaccine four to six weeks after tumors are removed, the company has said.
Antigenics hasn’t been able to start selling its treatment in Russia as quickly as it would like, Uberoi says, because it took longer than expected to get an export license it needed from the FDA. If it can win approval in Europe, it will be interesting to see what Antigenics’ next chess move will be back here in the U.S., the world’s largest healthcare market.