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Detailed safety data from the registrational bioequivalence clinical studyis available on the website of the American Society of Clinical Oncology (ASCO)at http://www.asco.org. The abstract, entitled "Tolerability and incidence ofinfusion site reactions with emulsion formulation of vinorelbine (ANX-530)compared to vinorelbine solution," will be published in the 2008 Proceedings ofthe American Society of Clinical Oncology in connection with ASCO's 2008 AnnualMeeting, which takes place May 30 - June 3, 2008 in Chicago, IL.
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"We are encouraged by these data and pleased that our goal to improve thesafety of vinorelbine has been observed in the clinic," stated Evan M. Levine,Chief Executive Officer and President of ADVENTRX. "The improvement ininjection site reactions could translate into a real benefit for patients aswell as healthcare practitioners."
A summary of all reported general disorders and administration siteconditions is set forth in the following table:
General disorders and administration site conditions denotes thesystem/organ/class MedDRA term. Injection site reactions consist of all gradesof investigator-reported phlebitis, irritation and pruritus, in each case atthe site of injection. Adverse events were graded based on the investigator'sassessment of severity.
The bioequivalence study of ANX-530 was a crossover comparison of ANX-530and Navelbine with a primary objective of demonstrating the pharmacokineticequivalence of ANX-530 and Navelbine. Determining the safety of a single doseof ANX-530 was a secondary objective. In the first week, patients were dosedwith either ANX-530 or Navelbine, and after a washout period, were dosed withthe opposite drug during the second week of treatment. Pharmacokineticequivalence, the primary endpoint of the study, was observed between ANX-530and Navelbine.
ADVENTRX intends to submit to the U.S. Food and Drug Administration (FDA) aSection 505(b)(2) NDA for ANX-530 around the end of 2008.
About ANX-530 (vinorelbine emulsion)
ANX-530 is a novel emulsion formulation of the chemotherapy drugvinorelbine. Navelbine, a branded formulation of vinorelbine, is approved inthe U.S. to treat advanced non-small cell lung cancer as a single agent or incombination with cisplatin, and approved in the European Union to treat non-small cell lung cancer and advanced or metastatic breast cancer. Worldwidesales of Navelbine and generic formulations of vinorelbine in 2006 were inexcess of $200 million.
Navelbine and its generic equivalents are often associated with injectionsite reactions, including phlebitis, erythema and pain at the site ofinjection. Studies have shown these reactions occur in approximately one-thirdof patients, with 5% of the reactions categorized as severe. ANX-530 isdesigned to reduce the incidence and severity of these injection sitereactions. The Company's formulation emulsifies vinorelbine into a homogeneoussuspension of nanoparticles that is designed protect the venous endotheliumduring administration into a peripheral vein, thereby reducing irritationassociated with administration of the drug.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a biopharmaceutical company focused onin-licensing, developing and commercializing proprietary product candidatesprimarily for the treatment of cancer and infectious diseas
