Adventrx Pharmaceuticals, Inc., a biopharmaceutical research and development company, announced that the US Food and Drug Administration (FDA) has granted fast track designation for ANX-510, or CoFactor 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). 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.
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.