Adventrx gets FDA fast track designation for cancer injection

CoFactor is a folate-based biomodulator drug designed to enhance the activity and reduce associated toxicity of the cancer chemotherapeutic agent 5-FU. It is currently being investigated in a pivotal Phase III study, with 5-fluorouracil (5-FU) and bevacizumab.

The fast track programs of the 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.

Adventrx is currently conducting a 1,200-patient, Phase III clinical study of CoFactor for the treatment of metastatic colorectal cancer across the US and in Europe. Patients are randomized to two arms containing either CoFactor or leucovorin, each in combination with 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 5-FU. Adventrx says that 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.