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Adventrx Pharmaceuticals, Inc.
Adventrx receives U.S. Food and Drug Administration clearance to initiate CoFactor phase III trial
June 23rd, 2006
Adventrx Pharmaceuticals, Inc., (ANX) has reached an agreement under a special protocol assessment (SPA) with the U.S. Food and Drug Administration (FDA) on the design of the company's CoFactor phase III clinical trial protocol. The company also announced it remains on track to initiate the phase III clinical trial in Q2 2006. CoFactor is a biomodulator drug designed to improve the efficacy and safety of the widely used chemotherapeutic agent, 5-fluorouracil (5-FU). The SPA documents the FDA's agreement that the design and planned analysis of the phase III study adequately address the objectives necessary to support a regulatory submission for...
Source: Biotech Law Weekly (2006-06-23)
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