SAN DIEGO, Feb. 7 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. (Amex: ANX), announced today that complete pharmacokinetic data from the Company's marketing-enabling bioequivalence clinical study of ANX-530 (vinorelbine emulsion) has been accepted for presentation at the 2008 American Association for Cancer Research (AACR) Annual Meeting, which takes place April 12 - 16, 2008 in San Diego, CA.
The poster presentation entitled "Pharmacokinetic equivalence observed between an emulsion formulation of vinorelbine (ANX-530) and vinorelbine solution in a clinical study of patients with advanced cancer," is scheduled to be presented on April 13, 2008.
ADVENTRX recently completed a marketing-enabling bioequivalence clinical study of ANX-530. The primary endpoint in the study was met, with pharmacokinetic equivalence observed between ANX-530 and the reference drug Navelbine(R). Furthermore, ANX-530 demonstrated a statistically significant reduction in injection site reactions when compared to Navelbine. Presentation of complete safety results including injection site reactions, have been submitted for presentation at an upcoming oncology conference. ADVENTRX intends to submit to the U.S. Food and Drug Administration (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 designed to reduce the incidence and severity of injection site reactions from intravenous delivery of vinorelbine tartrate. Vinorelbine tartrate works by disrupting microtubule formation and is a member of the vinca alkaloid class of antineoplastic agents. Vinorelbine is indicated as a single agent or in combination with cisplatin for treatment of advanced non-small cell lung cancer and has also shown activity in breast, ovarian, and other cancers.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a biopharmaceutical research and development company focused on commercializing proprietary product candidates for the treatment of cancer and infectious diseases. The Company seeks to improve the performance and safety of existing treatments by addressing significant problems, such as drug metabolism and bioavailability, excessive toxicity and treatment resistance. 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 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; 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; 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; ADVENTRX's lack of long-term agreements with suppliers of ANX-530 components and contract manufacturers of ANX-530, including its inability to timely secure commercial quantities of ANX-530 or its components on commercially reasonable terms, or at all; uncertainty under Section 505(b)(2) resulting from legal action against the FDA and the potential that future interpretations of Section 505(b)(2) could delay or prevent the FDA from approving any Section 505(b)(2) NDA; 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.
