SAN DIEGO, April 15 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. (Amex: ANX) announced that it presented pharmacokinetic data from its registrational bioequivalence clinical study of ANX-530 (vinorelbine emulsion) at the 2008 American Association for Cancer Research (AACR) Annual Meeting. 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," was presented by Joachim P.H. Schupp, M.D., Vice President of Medical Affairs, on April 13.
"ANX-530 is a near term value-driver for ADVENTRX and we are excited to have met the primary endpoint in this registrational trial," stated Evan M. Levine, Chief Executive Officer and President of ADVENTRX. "We are preparing our New Drug Application (NDA) for ANX-530, which we anticipate submitting before the end of this year. ANX-530 could be our first commercially available oncology product and, if approved by the FDA within its 10 month review goal, may generate revenues for the company towards the end of 2009."
The bioequivalence study of ANX-530 was a crossover comparison of ANX-530 and Navelbine with a primary objective of demonstrating the pharmacokinetic equivalence of ANX-530 and Navelbine. Determining the safety of a single dose of ANX-530 was a secondary objective. In the first week, patients were dosed with either ANX-530 or Navelbine, and after a washout period, were dosed with the opposite drug during the second week of treatment.
Pharmacokinetic equivalence was demonstrated by a statistical comparison of both the areas under the curve (AUC) and maximum plasma concentrations (Cmax) and was determined based on federal regulations and FDA guidance regarding bioequivalence studies. AUC is a measure of the total amount of the drug circulating in the body over time. Cmax is the maximum concentration of the drug measured in the blood at any given time. If the upper and lower bounds of the AUC ratio's and the Cmax ratio's 90% confidence interval ranged from 0.80 to 1.25, ANX-530 and Navelbine were considered to have equivalent pharmacokinetics. The results of a clinical study are actually estimates of what might be expected if the treatment were to be given to the entire population of interest. Confidence intervals indicate the precision of such an estimate. Pursuant to the study's protocol and statistical analysis plan, data from all 31 patients who received both study drugs were included in the analysis.
A summary of the pharmacokinetic results is set forth in the following table:
Both ANX-530 and Navelbine were administered via a 10 minute intravenous injection at a dose of 30 mg/m2. Blood samples for pharmacokinetic analysis were collected prior to the initiation of patient dosing, and, at 10, 20, and 40 minutes after patient dosing, as well as at 1, 3, 6, 24, 48, 72, and 144 hours after the end of the infusion. Hematology, serum chemistry, and adverse event reporting were performed throughout the study period.
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 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.
