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news.Adventrx Pharmaceuticals has entered into an agreement with Hyaluron Contract Manufacturing to manufacture its new cancer drug for preclinical and clinical studies.
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Adventrx is conducting preclinical pharmacokinetic testing of the drug, ANX-514, to compare this product candidate with the approved version of the product, marketed under the brand name Taxotere.
“ANX-514 fits well with our approach of developing less toxic drugs and improving patient care. 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,” said Evan Levine, CEO of Adventrx.
ANX-514 is a novel nano-emulsion formulation of the chemotherapy drug docetaxel, a product marketed under the brand name Taxotere. ANX-514 is designed to eliminate the need for multi-day immunosuppressant premedication. Docetaxel is an anticancer agent that is approved to treat breast, non-small cell lung, prostate, gastric and head and neck cancers.