ADVENTRX Announces ANX-530 Safety Data From Registrational Bioequivalence Clinical Study- ANX-530 Demonstrates Statistically Significant Reductions in Selected Safety Observations
SAN DIEGO, May 16, 2008 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. announced today that, in a registrational bioequivalence clinical study, ANX-530 demonstrated a statistically significant reduction in general disorders and administration site conditions when compared to Navelbine(R) (p=0.014). In addition, in post hoc analyses, ANX-530 demonstrated a statistically significant reduction in injection site reactions when compared to Navelbine (p<0.01). ANX-530 was determined generally to be safe and well-tolerated.
Detailed safety data from the registrational bioequivalence clinical study is available on the website of the American Society of Clinical Oncology (ASCO) at http://www.asco.org. The abstract, entitled "Tolerability and incidence of infusion site reactions with emulsion formulation of vinorelbine (ANX-530) compared to vinorelbine solution," will be published in the 2008 Proceedings of the American Society of Clinical Oncology in connection with ASCO's 2008 Annual Meeting, which takes place May 30 - June 3, 2008 in Chicago, IL.
"We are encouraged by these data and pleased that our goal to improve the safety of vinorelbine has been observed in the clinic," stated Evan M. Levine, Chief Executive Officer and President of ADVENTRX. "The improvement in injection site reactions could translate into a real benefit for patients as well as healthcare practitioners."
A summary of all reported general disorders and administration site conditions is set forth in the following table:
System Organ Class/Preferred Term ANX-530 Navelbine P value General Disorders and Administration Site Conditions 5 14 0.014 Infusion Site Phlebitis 1* 7 - Asthenia 3 3 - Fatigue 1 1 - Infusion Site Irritation 0 1 - Infusion Site Pruritis 0 1 - Pyrexia 0 1 - * One event of infusion site phlebitis was excluded based on its proximity to an additional dose of Navelbine administered during the study's follow up period. A summary of post-hoc analyses regarding injection site reactions is set forth in the following table: ANX-530 Navelbine P value Injection Site Reactions 1 9 <0.01 Infusion Site Phlebitis 1 7 0.03 Infusion Site Irritation 0 1 - Infusion Site Pruritis 0 1 -
General disorders and administration site conditions denotes the system/organ/class MedDRA term. Injection site reactions consist of all grades of investigator-reported phlebitis, irritation and pruritus, in each case at the site of injection. Adverse events were graded based on the investigator's assessment of severity.
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, the primary endpoint of the study, was observed between ANX-530 and Navelbine.
ADVENTRX intends to submit to the U.S. Food and Drug Administration (FDA) a Section 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 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. The Company'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, obtaining regulatory approval for and marketing ANX-530, including validating commercial manufacturers and suppliers and the potential for automatic injunctions regarding FDA approval of ANX-530; 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.
CONTACT: investors, Ioana C. Hone of ADVENTRX Pharmaceuticals, Inc.,+1-858-552-0866
Web site: http://www.adventrx.com/
Ticker Symbol: (AMEX:ANX)
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Posted: May 2008