SAN DIEGO, March 10 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. (Amex: ANX) announced today that complete safety data from its registrational bioequivalence clinical study of ANX-530 (vinorelbine emulsion) will be published in the 2008 Proceedings of the American Society of Clinical Oncology (ASCO) in connection with ASCO's 2008 Annual Meeting, which takes place May 30 - June 3, 2008 in Chicago, IL. The abstract, entitled "Tolerability and incidence of infusion site reactions with emulsion formulation of vinorelbine (ANX-530) compared to vinorelbine solution," will be published.
ADVENTRX recently completed a registrational bioequivalence clinical study of ANX-530. Pharmacokinetic equivalence, the primary endpoint of the study, was observed between ANX-530 and Navelbine(R). Furthermore, in post hoc analyses, ANX-530 demonstrated a statistically significant reduction in injection site reactions when compared to Navelbine. ADVENTRX intends to submit to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2008 a Section 505(b)(2) NDA for ANX-530.
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. Our 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 drug.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates primarily for the treatment of cancer and infectious disease. The Company seeks to improve the performance and commercial potential of existing treatments by addressing problems associated with these treatment regimens. More information can be found on ADVENTRX's web site at http://www.adventrx.com.
Forward Looking Statement
ADVENTRX cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements that involve risks and assumptions that, if they materialize or do not prove to be accurate, could cause ADVENTRX's results to differ materially from historical results or those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk the FDA will determine that ANX-530 and Navelbine are not bioequivalent, including as a result of performing pharmacokinetic equivalence analysis based a patient population other than the population on which ADVENTRX based its analysis; the risk of investigator bias in reporting adverse events as a result of the study's open-label nature, including bias that increased the reporting of adverse events associated with Navelbine and/or that decreased the reporting of adverse events associated with ANX-530; difficulties or delays in manufacturing, marketing and obtaining regulatory approval for ANX-530, including validating commercial manufacturers and suppliers and the potential for automatic injunctions regarding FDA approval of ANX-530 and other challenges by patent holders during the Section 505(b)(2) process; the risk that ADVENTRX will be unable to raise sufficient capital to fund the projects necessary to meet its goals, including funding the continued development and commercialization of ANX-530; the potential for regulatory authorities to require additional preclinical work or other clinical requirements to support regulatory filings; patent and non-patent exclusivity covering Navelbine; and other risks and uncertainties more fully described in ADVENTRX's press releases and periodic filings with the Securities and Exchange Commission. ADVENTRX's public filings with the Securities and Exchange Commission are available at http://www.sec.gov.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date when made. ADVENTRX does not intend to revise or update any forward-looking statement set forth in this press release to reflect events or circumstances arising after the date on which it was made.
SOURCE ADVENTRX Pharmaceuticals, Inc.