Docetaxel reduces hypersensitivity reactions in preclinical study

In an established animal model, anaphylactoid clinical reactions were observed following Taxotere administration, including decreased respiration, swelling and tremors. Furthermore, decreases in blood pressure and increases in histamine levels were observed within 10-20 minutes of Taxotere administration.

In contrast, hypersensitivity reactions were not observed following administration of docetaxel emulsion (ANX-514), specifically, no treatment-related change in blood pressure and no increase in histamine levels were observed.

In this crossover design study, even on re-challenge at three weeks, hypersensitivity reactions were observed only in the Taxotere treated animals. In two separate studies in different animal species, ANX-514 showed bioequivalent pharmacokinetics to Taxotere. Moreover, in an established in vivo model, ANX-514 demonstrated dose-dependent inhibition of tumor growth with equivalent antitumor activity when compared to Taxotere at equal dose levels.

Evan Levine, CEO of Adventrx, said: “We feel the reduced hypersensitivity reactions associated with ANX-514 would be a benefit to patients and a way to differentiate ANX-514. We remain focused on initiating a marketing-enabling clinical trial of ANX-514 later this year, pending appropriate regulatory clearances.”