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news.Polyphenon Pharma has announced that the FDA has granted orphan drug designation to its botanical drug, Polyphenon E, for the treatment of chronic lymphocytic leukemia.
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A Phase II study is currently underway at the Mayo Clinic in Rochester, Minnesota where researchers are studying the effects of an oral daily dose of Polyphenon E in chronic lymphocytic leukemia (CLL) patients.
This orphan drug designation will entitle Polyphenon Pharma to seven years of marketing exclusivity for the drug upon FDA approval.
Stig Ogata, COO of Polyphenon, said: “Orphan drug status provides incentives that can help accelerate the development process of Polyphenon E as an oral treatment for patients with CLL. This in turn could lead to other potential development opportunities for this drug in the area of oncology.”