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FDA Law Weekly

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Cancer Vaccines



Stimuvax Cancer Vaccine Phase III Study Begins



March 15th, 2007

Merck KGaA announced that the first patient has been enrolled in its global Phase III clinical study, START (Stimulating Targeted Antigenic Responses To NSCLC), assessing the efficacy and safety of Stimuvax (BLP25 liposome vaccine) as a potential treatment for patients with unresectable stage III non-small cell lung cancer (NSCLC).

Enrollment in the study, which will involve more than 1,300 patients in approximately 30 countries, is now open to patients in the U.S. where the first randomization has occurred. Enrollment will subsequently expand to additional countries. Currently, there are no approved maintenance therapies for patients responding to first-line treatment...


Source: FDA Law Weekly (2007-03-15)

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