Adventrx Pharmaceuticals has received fast track designation from FDA for its folate-based biomodulator CoFactor (ANX-510) in the treatment of metastatic colorectal cancer, the firm announced Aug. 16.

The San Diego-based company expects to complete enrollment by the end of 2008 in a Phase III trial designed under a special protocol assessment with the agency. About 1,200 MCC patients will be randomized to receive treatment with CoFactor or leucovorin in combination with 5-fluorouracil and Genentech's Avastin (bevacizumab) (¹ Also see "Adventrx To Begin Phase III Trial Of CoFactor In Q2" - Pink Sheet, 22 May, 2006.).

Adventrx also is nearing completion of Phase IIb studies of CoFactor in MCC and expects to announce top-line results by year end. The Phase IIb trial is a 300-patient randomized, controlled, two-arm open label safety study with a primary endpoint assessing the incidence and severity of grade 3 and 4 hematological and gastrointestinal toxicity of the two treatment groups CoFactor/5-FU and leucovorin/5-FU.

With the Phase IIb results in hand, the firm expects to approach the European Medicines Agency regarding its requirements for marketing CoFactor in the European Union, specifically whether a single Phase III pivotal trial would be sufficient for approval, according to the firm.

CoFactor creates a more stable bond between the active form of 5-FU and the target enzyme thymidylate synthase. That bond improves the performance of 5-FU and reduces toxicity associated with the chemotherapy, according to Adventrx.

The firm believes that CoFactor has the potential to replace leucovorin in cancer treatment regimens that use 5-FU.

Adventrx also is conducting Phase II studies of CoFactor in the treatment of advanced breast cancer. It expects to complete enrollment in a 31-patient single-arm study with a primary endpoint of objective response rate by the end of 2007.

"This should help us to determine a protocol for Phase III pivotal study in breast cancer," CEO Evan Levine said during an Aug. 2 conference call with investors reporting the firm's second-quarter earnings results.

Adventrx expects results by year end in a 28-patient bioequivalence study of ANX-530 (vinorelbine emulsion) for the treatment of various cancers. The trial is a crossover comparison of ANX-530 and vinorelbine (GlaxoSmithKline's Navelbine and generics). FDA has told the firm that positive results of the bioequivalence study should provide sufficient clinical data to support a 505(b)(2) NDA filing.

Vinorelbine is currently used as a monotherapy or in combination with other agents to treat non-small cell lung, breast, ovarian and other cancers. The emulsion formulation is designed to protect the venous endothelium from coming into direct contact with the drug and thereby reducing vein irritation, according to Adventrx.

Adventrx plans to file an IND this year for ANX-201 (thiophosphonoformate), a novel reverse transcriptase inhibitor designed for the treatment of HIV. The firm has preclinical data that ANX-201 demonstrates synergistic inhibition of HIV-1 when combined with nucleoside and nucleotide reverse transcriptase inhibitors.

-Pamela Taulbee (p.taulbee@elsevier.com)

Adventrx CoFactor Gets FDA Fast Track Designation For Colorectal Cancer

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