>>Nuvelo Initiates Phase 2 Trial of rNAPc2 in Patients with Metastatic Colorectal Cancer
Thursday January 4, 6:30 am ET
SAN CARLOS, Calif., Jan. 4 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced that patient enrollment 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.
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The primary objectives of the multi-center, 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 randomize 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 enroll 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, M.D., 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 tumor volume were suppressed by rNAPc2 alone or in combination with 5-FU."<<and it's all we've got left.
I hadn't known there was a cancer angle to rNAPc2. Interestingly, the seminal work in the area was done by EntreMed.
cancerres.aacrjournals.org
Full text freebie. Still thinking they are grasping at straws, but that's what biotechs do in this situation. Still, the dose used in the above study was lower than that being used in this human study, so NUVO should hit the therapeutic window if it is there. However, this something of an apples to oranges comparison, because the EntreMed study involved a melanoma model and mice.
Cheers, Tuck |
