SAN DIEGO, Dec. 1 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today announced that a new, recently completed preclinical study has affirmed the bioequivalence and comparable toxicity of ANX-514 and Taxotere® (docetaxel). Shin Poong Pharmaceuticals, ADVENTRX's partner for ANX-514 in South Korea, independently conducted the study and data analysis.
"Our independent confirmation of the bioequivalence and comparable overall safety of ANX-514 and Taxotere affirm our belief in both the emulsion platform technology underlying several ADVENTRX product candidates and its application to docetaxel," stated Mr. Byung Yong Kim, Executive Managing Director of Shin Poong Pharmaceuticals. "We intend next to conduct a separate clinical bioequivalence study of ANX-514 in South Korea and look forward to continuing to work with ADVENTRX toward the possible commercialization of ANX-514 in both the U.S. and South Korea."
About ANX-514 (docetaxel emulsion)
ANX-514 is a novel emulsion formulation of the chemotherapy drug docetaxel, a formulation of which is marketed under the brand name Taxotere. ANX-514 is formulated without polysorbate 80 or other detergents and is intended to reduce the severity and/or incidence of the hypersensitivity reactions often associated with Taxotere.
In May 2009, ADVENTRX announced the results of a clinical bioequivalence study of ANX-514. ANX-514 was determined to have comparable overall safety as Taxotere, with no differences between treatment groups in severe toxicities. However, pharmacokinetic equivalence, the primary endpoint of the study, was not demonstrated based on benchmark regulatory standards. The study data revealed higher blood-levels of docetaxel during and immediately following infusion of the study drug (i.e., during the first hour of treatment) in patients receiving ANX-514 relative to those receiving Taxotere, but, at 10 minutes after the completion of infusion, docetaxel blood-levels were comparable and remained so through the end of the observation period. ADVENTRX is analyzing these short-term increased levels, which were the reason ANX-514 was outside benchmark regulatory standards for determining bioequivalence.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a specialty pharmaceutical company whose product candidates are designed to improve the performance of existing cancer treatments by addressing limitations associated principally with their safety and use. More information can be found on the Company's web site at www.adventrx.com.
Forward Looking Statements
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 that preclinical results are not predictive of the success of subsequent clinical trials and that products will not perform as preclinical data suggests or as otherwise anticipated; the robustness of the preclinical study conducted by Shin Poong Pharmaceuticals and the validity of any conclusions drawn therefrom, including the risk that ADVENTRX did not independently verify the data or conclusions provided by Shin Poong Pharmaceuticals; the risk the FDA will determine that ANX-514 and Taxotere are not bioequivalent, including as a result of determining that increased docetaxel blood-levels during and immediately following infusion are clinically relevant; the risk that future studies of ANX-514, including those performed by Shin Poong Pharmaceuticals, will not demonstrate the bioequivalence of ANX-514 and Taxotere; the potential for regulatory authorities to require additional preclinical work and/or clinical activities to support regulatory filings, including prior to the submission or the approval of an NDA for ANX-514, which activities may increase the cost and timeline to NDA submission or approval and negatively impact ADVENTRX's ability to raise additional capital; the risk that ADVENTRX will be unable to raise sufficient additional capital to continue the development of ANX-514; the risk that ADVENTRX will be unable to raise sufficient additional capital on a timely basis to continue as a going concern; the risk that the performance of third parties on whom Shin Poong Pharmaceuticals relied to conduct its preclinical studies or evaluate the data, including contract laboratories and contract research organizations, may have been substandard, or they may have failed to perform as expected; 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.
|SOURCE ADVENTRX Pharmaceuticals, Inc.|
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