Nuvelo Initiates Phase 2 Trial of rNAPc2 in Patients with Metastatic Colorectal Cancer
- Category: Proteins and Peptides
- Published on Friday, 05 January 2007 02:00
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SAN CARLOS, CA, USA | Jan 04, 2006 | Nuvelo, Inc. (Nasdaq: NUVO) 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.
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."
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.
Results from a Phase 2 dose escalation safety trial of rNAPc2 in over 200 patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) demonstrated that rNAPc2 had an acceptable safety profile and was well tolerated in doses up to 10 micrograms/kg in patients being treated for NSTE- ACS. The results showed that treatment with rNAPc2, in addition to standard antithrombotic therapies in patients with ACS, resulted in a dose-related inhibition of thrombin generation without an increase in clinically significant bleeding. In addition, rNAPc2 suppressed F1+2 and prolonged the prothrombin time, both in a dose-related fashion.
About Metastatic Colorectal Carcinoma
mCRC is the second leading cause of cancer-related death and the third most commonly diagnosed cancer in the United States. According to the American Cancer Society, there were approximately 150,000 new cases of colorectal cancer diagnosed and 55,000 colorectal cancer deaths in 2006. Death secondary to mCRC often results directly from organ failure due to metastatic disease and thromboembolic events.
Nuvelo, Inc. is dedicated to improving the lives of patients through the discovery, development and commercialization of novel drugs for acute cardiovascular and cancer therapy. Nuvelo's development pipeline includes three acute cardiovascular programs: alfimeprase, a direct-acting thrombolytic in development for the treatment of thrombotic-related disorders; rNAPc2, an anticoagulant that inhibits the factor VIIa and tissue factor protease complex that completed Phase 2 clinical development in acute coronary syndromes; and preclinical candidate NU172, a direct thrombin inhibitor for use as a short- acting anticoagulant during medical procedures. Nuvelo is also advancing an emerging oncology pipeline, which includes NU206 for the potential treatment of chemotherapy/radiation therapy-induced mucositis and inflammatory bowel disease, as well as rNAPc2 for potential use as a cancer therapy. In addition, Nuvelo expects to leverage its expertise in secreted proteins and cancer antibody discovery to further expand its pipeline and create additional partnering and licensing opportunities.
Information about Nuvelo is available at our website at www.nuvelo.com or by phoning 650-517-8000.
This press release contains "forward-looking statements," which include statements regarding the potential use of rNAPc2 as a treatment for metastatic colorectal carcinoma, the timing and progress of Nuvelo's clinical stage and preclinical research programs, and the potential utility of compounds to treat particular indications, which statements are hereby identified as "forward- looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Such statements are based on our management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, uncertainties relating to drug discovery; clinical development processes; enrollment rates for patients in our clinical trials; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; and the impact of competitive products and technological changes. These and other factors are identified and described in more detail in Nuvelo filings with the SEC, including without limitation Nuvelo's Quarterly Report on Form 10-Q for the quarter ended September 30, 2006 and subsequent filings. We disclaim any intent or obligation to update these forward-looking statements.
SOURCE Nuvelo, Inc.