Nuvelo Inc. has announced that patient enrolment has begun in a phase 2 trial of recombinant nematode anticoagulant protein c2 (rNAPc2) for the treatment of metastatic colorectal carcinoma (mCRC), the second leading cause of cancer-related death in the United States.
The primary objectives of the multi-centre, two-stage trial are to determine the safety and efficacy of twice-weekly, subcutaneous rNAPc2 for the second-line treatment of mCRC in combination with 5-fluorouracil (5-FU)-based chemotherapy regimens. The first stage will evaluate the safety and activity of rNAPc2 in a three-tier dose escalation format (2.5, 5, and 10 micrograms/kg).
The second stage will randomise patients to doses determined safe during the first stage by an independent Data Monitoring Committee (DMC) and placebo in conjunction with standard chemotherapy regimens. Nuvelo plans to enrol up to 100 patients in the study.
"Even with recent improvements in combination chemotherapy and targeted biologic therapies, the majority of mCRC patients still develop progressive disease following treatment," said Michael Levy, MD, senior vice president of research and development for Nuvelo. "We are committed to developing rNAPc2 because we believe it offers the potential to help this patient population based on our in vitro results where both metastasis and tumour volume were suppressed by rNAPc2 alone or in combination with 5-FU."
Recombinant nematode anticoagulant protein c2 (rNAPc2) is a recombinant protein fashioned after one originally isolated from the saliva of the dog hookworm. The factor VIIa/tissue factor protease complex has been shown to play a role in the cellular signaling of both metastasis and angiogenesis in a variety of cancers. In addition, rNAPc2 is an anticoagulant, which results from its ability to block the factor VIIa/tissue factor protease complex, which is responsible for the initiation of blood clot formation.