FDA Grants Intracel Special Protocol Assessment For Confirmatory, Pivotal Phase III Study Of OncoVAX(R) Colon Cancer Vaccine
7/19/2006 11:27:47 AM
FREDERICK, Md.--(BUSINESS WIRE)--July 19, 2006--Intracel, a biotechnology company developing patient-specific cancer immunotherapies, has been granted a special protocol assessment (SPA) by the U.S. Food and Drug Administration (FDA) for the execution of a confirmatory, Phase III clinical trial of OncoVAX, a patient-specific active immunotherapy, in stage II colon carcinoma. An SPA provides a mechanism for the FDA and sponsors to reach agreement on the design, size, execution and analysis of a clinical trial that is intended to form the primary basis for regulatory approval.
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