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news.Nuvelo has been granted two separate fast track designations by the FDA for its product candidate, rNAPc2, used as a first-line treatment of metastatic colorectal cancer.
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The first fast track designation is for the use of rNAPc2 as a first-line treatment 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 mCRC to improve progression-free survival and overall survival when added to 5-FU-based chemotherapy regimens.
Recombinant nematode anticoagulant protein c2 (rNAPc2) 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. In addition, rNAPc2 has been shown to have a potential anticoagulant effect.
rNAPc2 is currently being studied in a phase II trial in subjects with mCRC. The primary objectives of this trial are to determine the safety and efficacy of twice-weekly, subcutaneous rNAPc2 for the second-line treatment of mCRC in combination with select 5-FU-based chemotherapy regimens.