ADVENTRX Announces Fast Track Designation Granted By The FDA For CoFactor For The Treatment Of Metastatic Colorectal Cancer

Main Category: Colorectal Cancer
Also Included In: Clinical Trials / Drug Trials;  Regulatory Affairs / Drug Approvals
Article Date: 17 Aug 2007 - 0:00 PDT

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ADVENTRX Pharmaceuticals, Inc. (Amex: ANX) a biopharmaceutical research and development company focused on commercializing proprietary product candidates for the treatment of cancer and infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation for ANX-510, or CoFactor(R) injection, which is currently being investigated in a pivotal Phase 3 study, with 5-fluorouracil (5-FU) and bevacizumab for the initial treatment of metastatic colorectal cancer. CoFactor is a folate-based biomodulator drug designed to enhance the activity and reduce associated toxicity of the widely used cancer chemotherapeutic agent 5-FU.

"The FDA's fast track designation represents a significant step towards bringing CoFactor to market as rapidly as possible," stated Evan M. Levine, chief executive officer of ADVENTRX. "We look forward to working closely with the FDA to expedite the review and approval process for CoFactor."

The fast track programs of the Food and Drug Administration (FDA) are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast track status enables a sponsor to have more frequent and timely communication and meetings with the FDA regarding product development plans and may also result in eligibility for priority review of New Drug Applications. Fast track designation does not apply to a product alone but a combination of a product and specific indication.

ADVENTRX is currently conducting a 1,200-patient, Phase 3 clinical study of CoFactor for the treatment of metastatic colorectal cancer across the U.S. and in Europe. Patients are randomized to two arms containing either CoFactor or leucovorin, each in combination with the widely used cancer chemotherapy regimen of 5-FU and bevacizumab (Avastin(R)). The primary endpoint for the study is progression-free survival. Secondary endpoints include response rate, overall survival and incidence and severity of adverse events. The protocol and planned analysis were developed with and accepted by the FDA under a Special Protocol Assessment.

About ANX-510, or CoFactor

CoFactor is a folate-based biomodulator drug designed to replace leucovorin as the preferred method to enhance the activity and reduce associated toxicity of the widely used cancer chemotherapeutic agent 5-FU. In comparison to leucovorin, CoFactor creates more stable binding of the active form of 5-FU to the target enzyme, thymidylate synthase (TS). CoFactor bypasses the metabolic pathway required by leucovorin to deliver the active form of folate, allowing 5-FU to work more effectively. CoFactor is in Phase 3 and Phase 2b clinical trials for the treatment of metastatic colorectal cancer, as well as in a Phase 2 clinical trial for the treatment of advanced breast cancer.

About ADVENTRX Pharmaceuticals

ADVENTRX Pharmaceuticals is a biopharmaceutical research and development company focused on commercializing proprietary product candidates for the treatment of cancer and infectious diseases. The Company seeks to improve the performance and safety of existing treatments by addressing significant problems, such as drug metabolism and bioavailability, excessive toxicity and treatment resistance. More information can be found on ADVENTRX's web site at http://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 potential for CoFactor to receive regulatory approval for metastatic colorectal cancer or other indications on a timely basis or at all; the uncertain process of seeking regulatory approval; difficulties or delays in developing, testing, manufacturing and marketing of CoFactor; the risk that ADVENTRX will be unable to raise sufficient capital to fund the projects necessary to meet its anticipated or stated goals and milestones; the ability to timely enroll subjects in ADVENTRX's current and anticipated clinical trials; the timing and success of clinical trials; the potential for regulatory authorities to require additional preclinical work or other clinical requirements to support regulatory filings; adverse side effects or inadequate therapeutic efficacy of CoFactor; the risk that preclinical results are not indicative of the success of subsequent clinical trials and that products will not perform as preclinical and clinical data suggest or as otherwise anticipated; 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 update any forward-looking statement, including as set forth in this press release, to reflect events or circumstances arising after the date on which it was made.

ADVENTRX Pharmaceuticals, Inc.
http://www.adventrx.com