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news.EntreMed has commenced a phase II clinical trial with its clinical-stage drug candidate Panzem in patients with recurrent or resistant epithelial ovarian cancer.
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Panzem is particularly targeting patients with ovarian cancer who have a clear cell subtype. Approximately 10% of ovarian cancer patients have clear cell histology, which is the most difficult subtype to treat and has a poorer prognosis than other ovarian subtypes.
Primary objectives for this phase II study will be to assess the safety, pharmacokinetics, tumor response rate, and progression-free survival.
Data from in vitro studies demonstrated that Panzem has activity against a variety of ovarian carcinoma cell lines including those resistant to other chemotherapeutic agents.
In preclinical models of ovarian cancer, Panzem has shown a significant survival advantage compared to animals who did not receive treatment. Furthermore, in a phase I clinical study conducted by the National Cancer Institute with Panzem Capsules, an ovarian cancer patient with the clear cell subtype experienced a durable partial response to Panzem lasting over three years after failing three prior chemotherapy regimens.
EntreMed received orphan drug designation for Panzem from the FDA for treatment of ovarian cancer.