SAN DIEGO, Feb. 5 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. , announced today that it has completed patient enrollment in its bioequivalence study of ANX-514 (docetaxel emulsion for injection). The Company is on track to announce results from this study in the second quarter of 2009.
ANX-514 is a reformulation of the blockbuster chemotherapeutic agent, Taxotere(R), an anti-cancer agent that is approved to treat breast, non-small cell lung, prostate, head and neck & gastric cancers. In 2007, the aggregate worldwide market for Taxotere was in excess of $3 billion.
The study is a multi-center, open-label, randomized two-period crossover comparison of ANX-514 and Taxotere, with a primary endpoint of pharmacokinetic equivalence of ANX-514 and Taxotere and a goal of 28 evaluable patients. The safety of a single dose of ANX-514 is being evaluated as a secondary endpoint. The U.S. Food and Drug Administration has indicated that this single study, should it demonstrate bioequivalence between ANX-514 and Taxotere, would provide sufficient human data to support the submission of an NDA.
About ANX-514 (docetaxel emulsion)
ANX-514 is a novel nano-emulsion formulation of the chemotherapy drug docetaxel, 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 hypersensitivity reactions. Docetaxel is an anti-cancer agent that acts by disrupting the cellular microtubular network that is essential for cell division. Immunosuppressant premedication is recommended for docetaxel therapy to reduce the incidence and severity of hypersensitivity reactions. Docetaxel is approved to treat breast, non-small cell lung, prostate, gastric and head and neck cancers.
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. The Company seeks to improve the performance and commercial potential of existing treatments by addressing problems associated with these treatment regimens. In December 2008, the Company announced that it is exploring a range of strategic options, including the sale or disposition of one or more of its product candidate programs, a strategic business merger and other transactions that maximize the value of the Company’s assets. More information can be found on ADVENTRX’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 ADVENTRX will be unable to consummate a strategic or partnering transaction or raise sufficient capital to fund the projects necessary to meet its goals, including funding the continued development and commercialization of ANX-530 or ANX-514; the risk that the Company’s recent cost-cutting measures, as well as any future workforce reductions and/or reductions/delays in spending, will negatively impact the Company’s development and commercialization plans, including its ability to achieve on time its previously stated goals; the risk that the departure of the Company’s former Chief Executive Officer and President and Executive Vice President and Chief Financial Officer and/or ADVENTRX’s leadership by a committee of executive officers will negatively impact ADVENTRX’s ability to execute its business plan or to maintain effective disclosure controls and procedures or internal control over financial reporting; the risk that the bioequivalence study of ANX-514 does not demonstrate pharmacokinetic equivalence or bioequivalence; difficulties or delays in manufacturing, obtaining regulatory approval for and marketing ANX-514, including validating commercial manufacturers and suppliers and the potential for automatic injunctions regarding FDA approval of ANX-514; the potential for regulatory authorities to require additional preclinical work or other clinical requirements to support regulatory filings, including prior to the submission or the approval of an NDA for ANX-514; the risk that the performance of third parties on whom ADVENTRX relies to conduct its studies or evaluate the data, including clinical investigators, expert data monitoring committees, contract laboratories and contract research organizations, may be substandard, or they may fail to perform as expected; the risk that ADVENTRX’s stockholders will not approve a strategic or capital-raising transaction recommended by ADVENTRX’s Board of Directors; 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, ADVENTRX Pharmaceuticals, Ioana C. Hone,
+1-858-552-0866
Web site: http://www.adventrx.com/
