The United States Food and Drug Administration (FDA) has granted Polyphenon Pharma orphan drug designation for their investigative agent Polyphenon E® for the treatment of chronic lymphocytic leukemia (CLL).
Polyphenon E is considered a botanical drug which contains catechins extracted from green tea leaves through a proprietary process. Epigallocatechin gallate (EGCG) is the primary catechin, and has demonstrated an effect on several processes involved in abnormal cellular activity associated with the development of cancer.
Polyphenon E is currently in a phase II study at the Mayo Clinic.
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