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U.S. FDA fast-tracks phenoxodiol for recurrent ovarian cancer.
2004 DEC 2 - (NewsRx.com & NewsRx.net) -- Marshall Edwards, Inc., (MSHL) announced that the U.S. Food and Drug Administration (FDA) has granted the investigational anticancer drug, phenoxodiol, fast track status for its intended use in patients with recurrent ovarian cancer.
The fast track application submitted to the FDA contained clinical data including tumor measurements based on radiographic examination. The data are from the current phase Ib/IIa study where patients with recurrent ovarian and primary peritoneal cancers are receiving phenoxodiol (intravenous dosage form) in combination with paclitaxel in those patients where the cancer is refractory or resistant to taxanes, or in combination with cisplatin where the cancer is refractory or resistant to platinum-based drugs.
Phenoxodiol is an investigational product that regulates signal transduction pathways in cancer cells resulting in the breakdown of the intracellular proteins - X-linked Inhibitor of Apoptosis Protein and Fas Ligand Inhibitory Protein - which block the ability of ...
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Source: HighBeam Research, U.S. FDA fast-tracks phenoxodiol for recurrent ovarian cancer.