SAN DIEGO, Dec. 15, 2010 /PRNewswire/ -- ADVENTRX Pharmaceuticals, Inc. (NYSEAmex : ANX ) today announced it has submitted a request to the U.S. Food and Drug Administration (FDA) to schedule a meeting for the purpose of discussing its product candidate ANX-514 (docetaxel emulsion for injection). The FDA is expected to set the meeting date within 60 days of receiving the request from ADVENTRX.
"We have performed an extensive analysis of the data from our bioequivalence study of ANX-514, as well as on results from other trials using Taxotere®, and plan to discuss our findings at the meeting," said Brian M. Culley, Chief Executive Officer of ADVENTRX.
"Based in part on the substantial variability observed with Taxotere as reported in the literature, we believe the transitory elevations in total docetaxel concentrations for ANX-514 do not affect adversely its safety or efficacy relative to Taxotere. However, the FDA is the final arbiter of safety and efficacy and, following our meeting, we will provide an update on the next steps and requirements for advancing ANX514 toward an NDA submission," Mr. Culley continued.
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 being developed to reduce the incidence and severity of side effects associated with detergents, such as hypersensitivity reactions.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a specialty pharmaceutical company whose product candidates are being developed to improve the performance of existing anti-cancer drugs 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 are based on ADVENTRX's current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements regarding the timing of a meeting with the FDA to discuss ANX-514 and ADVENTRX's ability to determine next steps and requirements for advancing ANX-514 toward an NDA submission based on the meeting and the safety and efficacy of ANX-514 relative to Taxotere. Actual events or results may differ materially from those expressed or implied by the forward-looking statements in this press release due to a number of risks and uncertainties, including, without limitation: the potential for the FDA to delay meeting with ADVENTRX regarding ANX-514; the potential for the FDA to disagree with ADVENTRX's conclusions regarding the safety and efficacy of ANX-514 relative to Taxotere based on the data from its bioequivalence study or to determine that ANX-514 and Taxotere are not bioequivalent, including as a result of determining that increased total docetaxel concentrations during and shortly following the end of the infusion are clinically significant; the risk that the FDA and other regulatory authorities will require additional nonclinical and/or clinical activities to support regulatory filings, including prior to the filing or the approval of a New Drug Application (NDA) for ANX-514, which activities may increase the cost and timeline to NDA filing or approval and may negatively impact ADVENTRX's ability to raise additional capital for development of and/or partner ANX-514; ADVENTRX's dependence on the success of ANX514 and the possibility that ADVENTRX does not receive regulatory approval of ANX-514 on a timely basis, or at all; the potential that changes made in transferring the manufacturing process for ANX-514 may result in a lack of comparability between the commercial product and the material used in the bioequivalence study and cause the FDA to require ADVENTRX to perform additional nonclinical or clinical studies; difficulties or delays in obtaining regulatory approval for ANX-514, even if regulatory authorities determine ANX-514 and Taxotere are bioequivalent, including the potential for automatic injunctions regarding FDA approval of ANX-514 and other challenges by patent holders during the Section 505(b)(2) process; difficulties or delays in manufacturing and marketing ANX-514, including validating commercial manufacturing processes and manufacturers, as well as suppliers; ADVENTRX's reliance on the performance of third parties to assist in the conduct of its bioequivalence studies, regulatory submissions, CMC activities and other important aspects of the ANX-514 development program, including analysis of the bioequivalence study data, and that such third parties may fail to perform as expected; the risk that ADVENTRX may not be able to successfully commercialize ANX-514 if it receives regulatory approval; the risk that ADVENTRX will pursue development activities at levels on timelines, or will incur unexpected expenses, that shorten the period through which its operating funds will sustain it; the potential for ADVENTRX to enter into a merger or other business combination in connection with a new product candidate acquisition resulting in a successor entity that focuses its resources on developing products and product candidates other than ADVENTRX's existing product candidates, including ANX-514; 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 www.sec.gov.
You are cautioned not to place undue reliance on 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 hereof, except as may be required by law.
SOURCE ADVENTRX Pharmaceuticals, Inc.