Adventrx says chemotherapy agent ANX-530 reduces vein irritation

By Elaine Rigoli

Tampa, Fla., April 5 - Adventrx Pharmaceuticals, Inc. presented preclinical study results showing an improved toxicity profile for its oncology compound ANX-530 (vinorelbine emulsion), an emulsion formulation of the Food and Drug Administration-approved drug vinorelbine tartrate.

The study results suggest lower venous toxicity of the emulsion formulation compared to the FDA-approved drug, vinorelbine solution, while maintaining similar antitumor activity and pharmacokinetics, according to a news release.

ANX-530 is a new formulation of vinorelbine that is designed to protect the venous endothelium during administration, therefore reducing vein irritation, a common side effect seen with the approved drug.

The company said it examined vein toxicity, edema and erythema in rabbits following repeated intravenous injections in the marginal ear vein.

For all toxicity parameters tested, animals dosed with ANX-530 showed less toxicity than those dosed with vinorelbine solution.

In addition, while all animals in the ANX-530 groups received the full set of repeated injections, animals in the vinorelbine solution group did not receive all the planned injections due to the severity of toxicity, the release said.

Moreover, tissue distribution following drug administration was assessed and showed significantly less drug accumulation in brain tissue in the ANX-530 group compared with the vinorelbine solution group, suggesting the potential for lower neurotoxicity, the release said.

Despite the toxicity differences, drug pharmacokinetics in rodent plasma, and anti-tumor activity in animals transplanted with human lung and breast tumor xenografts, was similar for both drugs.

"These preclinical findings for ANX-530 are encouraging since vein irritation is an important factor in patient comfort. If similar results are shown clinically, we believe there is potential for more widespread use of this active chemotherapy," chief scientific officer and executive vice president Joan M. Robbins said in the release.

"We intend to study vein irritation in the clinic during the bioequivalency trial with ANX-530, which is planned to begin in the fourth quarter of this year."

The presentation, entitled "A novel emulsion formulation of vinorelbine attenuates venous toxicity while maintaining antitumor efficacy," was presented Wednesday at the annual meeting of the American Association for Cancer Research.

Adventrx located in San Diego, is a biopharmaceutical research and development company focused on introducing new technologies for anticancer and antiviral treatments that address problems such as drug metabolism, toxicity, bioavailability and resistance.

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