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clinical development
pipeline
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Polyphenon E® has shown promise in the treatment of certain types of cancer, infectious disease, and neurological and urologic disorders.
Oral and topical delivery systems for Polyphenon E have already
been developed, and the Company is exploring delivery through intravenous infusion, bladder infusion, inhalation and other routes of administration.
Polyphenon E is the active ingredient in the FDA approved product Veregen®, which MediGene AG and Bradley Pharmaceuticals are marketing as a topical treatment for external and perianal genital warts. FDA approval of Veregen, the first for a complex botanical in many years, follows two successful Phase III clinical trials in Europe and the Americas involving more than 1,000 patients.
Polyphenon E is now being evaluated as an oral treatment for chronic lymphocytic leukemia in a study at the Mayo Clinic in Rochester, Minnesota and as an oral treatment for the prevention of prostate cancer in high risk subjects in a study at the H. Lee Moffitt Cancer Center & Research Institute in Tampa, Florida. The Company is also sponsoring preclinical studies of Polyphenon E in other areas including superficial bladder cancer.
Polyphenon Pharma Clinical Pipeline (click on indication
for more information)
Genital Warts:
Veregen®, topical
treatment for external genital and perianal warts licensed to
and marketed by Medigene/Bradley (Rights held at present by
Mitsui Norin Co., Ltd., our parent company).
High-grade Prostate Intraepithelial Neoplasia (HG-PIN) / Prostate Cancer Prevention:
Phase II 240 patient (oral dose) study conducted at the
H. Lee
Moffitt Cancer Center & Research Institute
Chronic Lymphocytic Leukemia (CLL):
Phase II (oral dose) study being conducted at
the Mayo Clinic
Superficial Bladder Cancer (Bladder instillation):
Preclinical
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