Adventrx Pharmaceuticals entered into an agreement with Hyaluron Contract Manufacturing related to ANX-514 (docetaxel emulsion). It is a novel nano-emulsion formulation of the chemotherapy drug docetaxel. The candidate is designed to eliminate the need for multiday immunosuppressant premedication.
Hyaluron will manufacture the product for preclinical and clinical studies. ANX-514 is formulated without polysorbate 80 or other detergents and is intended to reduce the severity and/or incidence of hypersensitivity reactions, according to Adventrx.
"We anticipate seeking guidance from the Food and Drug Administration with regard to a 505(b)(2) regulatory path for ANX-514 and pending appropriate clearances, initiating a marketing-enabling clinical trial of ANX-514 later this year," says Evan M. Levine, CEO of Adventrx.
Adventrx is conducting preclinical pharmacokinetic testing of ANX-514 to compare this product candidate with the approved version of the docetaxel, marketed under the brand name Taxotere.