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-- There was also a promising trend for overall survival associated with Oncophage in the eligible patient population (n = 604). As of data cut-off on January 2, 2006, 24 additional deaths have been reported, with six in the Oncophage arm and 18 in the observation arm, bringing the total to 37 (12.3 percent) and 40 (13.2 percent) deaths, respectively.
-- Adverse events reported during the trial were generally mild and expected. The more frequently reported adverse events were mainly constitutional in nature or related to the actual injection.
The company is working with study investigators to publish the final findings in a peer-reviewed medical journal.
Antigenics To Continue To Follow Patients for Recurrence-Free Survival and Overall Survival Through a Global Patient Registry
A global patient registry is being launched to continue collecting data on all patients from the trial for recurrence-free survival and overall survival. The registry, which is expected to provide additional data on the effectiveness of Oncophage, will follow patients for an additional three years from closure of the initial trial, providing more than five years' worth of data collection from the last patient enrolled.
Global Registrational Strategy
Antigenics intends to seek a meeting with US Food and Drug
Administration to discuss the results of the updated analyses
utilizing data through March 2007 to determine whether there is an
opportunity to file a biologics license application (BLA) on the
basis of these results along with appropriate commitments to
conduct further clinical investigations to support the efficacy of
Oncophage in renal cell carcinoma. Antigenics also plans to explore
the need for further clinical studies to support approval of
Onc
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