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"The FDA's fast track designation represents a significant step towardsbringing CoFactor to market as rapidly as possible," stated Evan M. Levine,chief executive officer of ADVENTRX. "We look forward to working closely withthe FDA to expedite the review and approval process for CoFactor."
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The fast track programs of the Food and Drug Administration (FDA) aredesigned to facilitate the development and expedite the review of new drugsthat are intended to treat serious or life-threatening conditions and thatdemonstrate the potential to address unmet medical needs. Fast track statusenables a sponsor to have more frequent and timely communication and meetingswith the FDA regarding product development plans and may also result ineligibility for priority review of New Drug Applications. Fast trackdesignation does not apply to a product alone but a combination of a productand specific indication.
ADVENTRX is currently conducting a 1,200-patient, Phase 3 clinical studyof CoFactor for the treatment of metastatic colorectal cancer across the U.S.and in Europe. Patients are randomized to two arms containing either CoFactoror leucovorin, each in combination with the widely used cancer chemotherapyregimen of 5-FU and bevacizumab (Avastin(R)). The primary endpoint for thestudy is progression-free survival. Secondary endpoints include responserate, overall survival and incidence and severity of adverse events. Theprotocol and planned analysis were developed with and accepted by the FDAunder a Special Protocol Assessment.
About ANX-510, or CoFactor
CoFactor is a folate-based biomodulator drug designed to replaceleucovorin as the preferred method to enhance the activity and reduceassociated toxicity of the widely used cancer chemotherapeutic agent 5-FU. Incomparison to leucovorin, CoFactor creates more stable binding of the activeform of 5-FU to the target enzyme, thymidylate synthase (TS). CoFactorbypasses the metabolic pathway required by leucovorin to deliver the activeform of folate, allowing 5-FU to work more effectively. CoFactor is in Phase 3and Phase 2b clinical trials for the treatment of metastatic colorectalcancer, as well as in a Phase 2 clinical trial for the treatment of advancedbreast cancer.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a biopharmaceutical research and developmentcompany focused on commercializing proprietary product candidates for thetreatment of cancer and infectious diseases. The Company seeks to improve theperformance and safety of existing treatments by addressing significantproblems, such as drug metabolism and bioavailability, excessive toxicity andtreatment resistance. More information can be found on ADVENTRX's web site atwww.adventrx.com.
Forward-Looking Statements
ADVENTRX cautions you that statements included in this press release thatare not a description of historical facts are forward-looking statements thatinvolve risks and assumptions that, if they materialize or do not prove to beaccurate, could cause ADVENTRX's results to differ materially from historicalresults or those expressed or implied by such forward-looking statements.These risks and uncertainties include, bu
