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ANX-513 (paclitaxel emulsion)ANX-513 is a novel formulation of the chemotherapy drug paclitaxel (brand name: Taxol®) that is intended to be non-allergenic and to obviate the need for immunosuppressant premedication. Immunosuppressant premedication is recommended for paclitaxel therapy to reduce the incidence and severity of hypersensitivity reactions. Paclitaxel is an antimicrotubule agent that inhibits the normal dynamic reorganization of the cellular microtubule network that is essential for cellular division. Paclitaxel is approved to treat breast, ovarian, Kaposi's sarcoma and non-small cell lung cancers. All taxanes, including paclitaxel and docetaxel are highly water-insoluble and therefore utilize certain non-ionic surfactants as drug formulation vehicles. Cremophor (Polyoxyl castor oil) is used to solubilize paclitaxel and is an active compound that can cause severe hypersensitivity reactions. It is recommended that all patients be premedicated with corticosteroids or anti-histamines prior to paclitaxel administration in order to prevent severe hypersensitivity reactions. Despite premedication, severe reactions may still occur. ANX-513 is formulated without Cremophor or detergents and is intended to eliminate the need for premedication with immunosuppressant drugs. Currently additional preclinical pharmacokinetic testing of ANX-513 is being conducted to compare this product candidate with the approved version of the product. |