In post hoc analyses, relative to Navelbine, ANX-530 demonstrated a statistically significant reduction in injection site reactions. Notably, the incidence of injection site reactions attributed to Navelbine was consistent with its product label. Furthermore, ANX-530 was determined to be safe and well-tolerated with no significant differences observed in any other safety parameters. Safety data from the study will be published in the 2008 Proceedings of the American Society of Clinical Oncology (ASCO) in connection with ASCO's 2008 Annual Meeting.
ADVENTRX is preparing and intends to submit to the FDA a Section 505(b)(2) New Drug Application (NDA) for ANX-530 in the fourth quarter of 2008.
About ANX-530 (vinorelbine emulsion)
ANX-530 is a novel emulsion formulation of the chemotherapy drug vinorelbine. Navelbine, a branded formulation of vinorelbine, is approved in the U.S. to treat advanced non-small cell lung cancer as a single agent or in combination with cisplatin, and approved in the European Union to treat non-small cell lung cancer and advanced or metastatic breast cancer. Worldwide sales of Navelbine and generic formulations of vinorelbine in 2006 were in excess of $200 million.
Navelbine and its generic equivalents are often associated with
injection site reactions, including phlebitis, erythema and pain at the
site of injection. Studies have shown these reactions occur in
approximately one-third of patients, with 5% of the reactions categorized
as severe. ANX-530 is designed to reduce the incidence and severity of
these injection site reactions. ADVENTRX's formulation emulsifies
vinorelbine into a homogeneous suspension of nanoparticles that is designed
protect the venous endothelium during administration into a peripheral
vein, thereby reducing irritation associated with administration of the
|SOURCE ADVENTRX Pharmaceuticals, Inc.|
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