ADVENTRX Announces Completion of Patient Enrollment in ANX-530 Marketing-Enabling Clinical Study
"Completing enrollment keeps us on schedule to announce results from thisstudy next month and, if the results are succesful, to submit an NDA as earlyas next year," said Evan M. Levine, chief executive officer of ADVENTRX."Advancing ANX-530 is a key value-driver for this company and we are takingthe steps to help ensure its success. We are preparing for a meeting with theFDA later this year and plan to provide an update regarding our NDA timelinefor ANX-530 following that meeting."
ANX-530 is currently being tested in a 28-patient bioequivalence study.The study is a crossover comparison of ANX-530 and Navelbine, also availableas generic vinorelbine, with a primary endpoint of pharmacokinetic equivalenceof ANX-530 and Navelbine. The safety of a single dose of ANX-530 is beingevaluated as a secondary endpoint. The FDA has indicated that this singleclinical study, should it demonstrate bioequivalence between ANX-530 andNavelbine, would provide sufficient clinical data to support the submission ofan NDA.
About ANX-530 (vinorelbine emulsion)
ANX-530 is a novel emulsion formulation of vinorelbine tartrate, a genericchemotherapy agent. ANX-530 is designed to reduce the incidence and severityof vein irritation from IV-delivery of vinorelbine tartrate. Vinorelbinetartrate works by disrupting microtubule formation and is a member of thevinca alkaloid class of antineoplastic agents. Vinorelbine is indicated as asingle agent or in combination with cisplatin for treatment of advancednon-small cell lung cancer and has also shown activity in breast, ovarian, andother cancers.
About Section 505(b)(2)
Section 505(b)(2) of the U.S. Food, Drug & Cosmetic Act (FDCA) allows theFood and Drug Administration (FDA) to approve a follow-on drug on the basis ofdata in the scientific literature or conclusions regarding safety oreffectiveness made by the FDA in the approval of other drugs. This regulatorypathway potentially makes it easier for drug manufacturers to obtain rapidapproval of new forms of drugs based on the FDA's approval of the originaldrug. Some examples of products that may be allowed to follow a 505(b)(2) pathto approval are drugs that have a new dosage form, strength, route ofadministration, formulation or indication. Upon approval, a drug may bemarketed only for the FDA-approved indications in the approved dosage forms.Further clinical trials are necessary to gain approval for the use of theproduct for any additional indications or dosage forms. To the extent aSection 505(b)(2) applicant is relying on the FDA's findings for analready-approved drug, the applicant is required to certify to the FDAconcerning any patents listed for the approved drug in the FDA's Orange Bookpublication, which may include a certification that listed patents are invalidor will not be infringed by the manufacture, use or sale of the new drug.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a biopharmaceutical research and developmentcompany focused on commercializing proprietary product candidates for thetreatment of cancer and infectious diseases. The Company seeks to improve theperformance and safety of existing treatment
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