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news.Adventrx Pharmaceuticals has completed patient enrollment in a study for its novel emulsion formulation of generic chemotherapy agent vinorelbine tartrate, which is approved to treat advanced non-small cell lung cancer as a single agent or in combination with cisplatin.
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Adventrx markets vinorelbine tartrate as Navelbine, but is developing ANX-530 as an emulsion formulation, designed to reduce the incidence and severity of vein irritation from IV-delivery of the drug. ANX-530 is currently being tested in a 28-patient bioequivalence study.
The study is a crossover comparison of vinorelbine tartrate emulsion and Navelbine, with a primary endpoint of pharmacokinetic equivalence of vinorelbine and Navelbine. The safety of a single dose of vinorelbine is being evaluated as a secondary endpoint. The FDA has indicated that this single clinical study, should it demonstrate bioequivalence between ANX-530 and Navelbine, would provide sufficient clinical data to support the submission of an NDA.
Evan Levine, CEO, said: “Completing enrollment keeps us on schedule to announce results from this study next month and, if the results are successful, to submit a new drug application (NDA) as early as next year. Advancing ANX-530 is a key value-driver for this company and we are taking the steps to help ensure its success. We are preparing for a meeting with the FDA later this year and plan to provide an update regarding our NDA timeline for ANX-530 following that meeting.”