Press Release: Nuvelo Gets Fast-Track Designation for Cancer Drug
Nuvelo Gets Fast-Track Designation for Cancer Drug SAN CARLOS, Calif., March 27 -- Nuvelo, Inc. today announced that it has been granted two separate fast track designations by the U.S. Food and Drug Administration (FDA) for its product candidate, rNAPc2. The first fast track designation is for first-line treatment of metastatic colorectal cancer (mCRC) to improve progression-free survival and overall survival when added to AvastinÂ®-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. Fast track designation, which was mandated by the FDA Modernization Act of 1997, can potentially facilitate development and expedited review of Biologics License Applications (BLA). Fast track designation is reserved for new drugs that demonstrate the potential to address an unmet medical need and are intended for the treatment of a serious or life-threatening condition. rNAPc2 is currently being studied in a Phase 2 clinical trial in subjects with mCRC, which accounted for approximately 55,000 colorectal cancer deaths in 2006. 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. "Given the magnitude of mCRC related deaths, there is a need for additional safe and effective treatments that prevent metastasis and prolong survival," said Michael Levy, M.D., executive vice president of research and development for Nuvelo. "We are pleased that the FDA has granted us fast track designation and are committed to developing rNAPc2 to further understand its potential to help this underserved patient population." About rNAPc2 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. This effect results from its ability to prevent new thrombin generation by blocking the factor VIIa/tissue factor protease complex, which is the initial step of coagulation or blood clot formation. About Colorectal Cancer Colorectal cancer is the second leading cause of cancer related death and the third most commonly diagnosed cancer in the United States. The American Cancer Society estimates that approximately 154,000 cases of colorectal cancer and 52,000 colorectal cancer deaths will occur in 2007. About Nuvelo 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 for the treatment of thrombotic-related disorders which is suspended pending review and analysis of clinical data; 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 or surgical procedures. Nuvelo is also advancing an emerging oncology pipeline, including rNAPc2 which is in Phase 2 testing for potential use as a cancer therapy, as well as NU206, a preclinical candidate for the potential treatment of chemotherapy/radiation therapy-induced mucositis and inflammatory bowel disease. 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 http://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 Annual Report on Form 10-K for the fiscal year ended December 31, 2006 and subsequent filings. We disclaim any intent or obligation to update these forward-looking statements.