FDA Grants Nuvelo's Cancer Drug Candidate Fast-Track Status

Nuvelo announced it has been granted two separate fast-track designations by the FDA for its product candidate, rNAPc2. The first designation is for first-line treatment of metastatic colorectal cancer to improve progression-free survival and overall survival when added to Avastin-containing 5- flurourocil (5-FU)-based chemotherapy regimens. The other is for second-line treatment of metastatic colorectal cancer to improve progression-free survival and overall survival when added to 5-FU-based chemotherapy regimens.

Fast-track designation, which was mandated by the FDA Modernization Act of 1997, can potentially facilitate development and expedited review of biologics license applications. Fast-track designation is reserved for any new drug that demonstrate the potential to address an unmet medical need and is intended for the treatment of a serious or life-threatening condition, according to Nuvelo.

The company's drug is currently being studied in a clinical trial in subjects with metastatic colorectal cancer. The primary objectives of this trial are to determine the safety and efficacy of twice-weekly, subcutaneous rNAPc2 for the second-line treatment of metastatic colorectal cancer in combination with select 5-FU-based chemotherapy regimens.

The drug is a recombinant protein that interferes with the tissue factor/factor VIIa/factor Xa protease complex. This complex has been shown to play a role in activating the cellular signaling events leading to metastasis and angiogenesis in a variety of cancers, the company said. In addition, rNAPc2 has been shown to have a potential anticoagulant effect. This effect results from its ability to prevent new thrombin generation by blocking the factor VIIa/tissue factor protease complex.