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Biotech / Medical : Nuvelo (Nasdaq: NUVO) -- Ignore unavailable to you. Want to Upgrade?

To: SemiBull who wrote (263)	6/5/2003 10:01:20 AM
From: tuck	Read Replies (1) \| Respond to of 286

>>SUNNYVALE, Calif., June 5 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced the commencement of dosing in a Phase II trial with its lead product candidate, alfimeprase, for the treatment of catheter occlusion. The multi-center, randomized, double-blind study will evaluate the safety and efficacy of alfimeprase for restoring function to occluded central venous catheters. The study will compare three doses of alfimeprase against the approved dose of t-PA (alteplase). Dr. Steven Deitcher, head of hematology and coagulation medicine at the Cleveland Clinic, will serve as the principal investigator of the study that will be conducted in approximately 100 patients across twenty centers in the United States. "This Phase II trial is very straightforward in its design," said Dr. Ted W. Love, president and chief executive officer of Nuvelo. "We should be able to evaluate clearance of the clot within hours of dosing patients with either alfimeprase or t-PA. In addition, this trial is designed to provide 'proof of concept' data and further safety information necessary to advance alfimeprase towards approval." Nuvelo previously announced positive Phase I results with its lead product candidate, alfimeprase, for the treatment of peripheral arterial occlusion (PAO) and expects to initiate an additional Phase II trial with alfimeprase in this primary indication in the second quarter of 2003. About Alfimeprase Alfimeprase is a modified fibrolase that directly degrades fibrin when delivered through a catheter at the site of a blood clot. Compared to traditional plasminogen activators, pre-clinical studies have shown alfimeprase to be up to six times faster in dissolving clots. In addition, alfimeprase's novel mechanism of action dramatically limits the molecule's systemic activity, reducing the risk of bleeding complications, a common side-effect of current therapies. Alfimeprase was identified through Amgen's research program and partnered with Nuvelo in January 2002 for development and commercialization. Under the terms of the collaboration, Nuvelo will lead all clinical development activities and Amgen will have the first right to manufacture alfimeprase. Amgen will have the option to lead the commercialization efforts in which both companies may participate. Both Amgen and Nuvelo share worldwide commercial rights. About Catheter Occlusion Catheter occlusion is the obstruction of flow through a central venous catheter by a blood clot. This impairs the ability to infuse medications or other fluids through the catheter. It is estimated that about five million catheters are placed in patients each year in the U.S., of which approximately 20-25% become occluded. As these catheters are primarily inserted in patients receiving life-saving medications such as chemotherapy, it is critical to restore flow through the catheter in a timely and cost-effective manner with minimal risk to the patient. In many cases, restoring flow is preferred over replacement of the catheter for several reasons including: limited interruption of therapy, reduced risk of trauma to the patient, reduced risk of complications and decreased cost. Treatment with thrombolytic drugs represents a less-invasive and more cost-effective alternative to replacement. Current treatment options include surgery to replace the catheter or treatment with Cathflo®Activase®, a recombinant form of a naturally-occurring enzyme, t-PA. About PAO PAO affects more than 100,000 people annually in the U.S. alone and occurs when arterial blood flow is blocked to an extremity of the body by a clot. PAO usually occurs in the leg and is the result of underlying peripheral arterial disease (PAD), in which chronic fatty plaque buildup restricts blood flow. The classic early symptom of PAD is leg pain or fatigue during activity that subsides with rest. Acute PAO is due to an occlusive blood clot which results in the total blockage of flow. If blood flow is not restored, this can lead to ulcers, gangrene, tissue death and ultimately to foot or leg amputation. Bypass surgery and angioplasty are established treatments for PAO; however treatment with thrombolytic drugs has presented a less-invasive and more cost-effective alternative. There are currently no products on the market widely used to treat PAO. With the limited treatment options currently available, alfimeprase has received orphan drug designation for the PAO indication. Webcast Information Ted W. Love, M.D. will be presenting at the Second Annual JMP Securities Research Conference in San Francisco, California, today, June 5, 2003 at 4:10 p.m. Pacific Time. A live audio webcast of the presentation will be available online at eventmanager.on24.com d=2214&sessionid=75&key=CF1B6C29CBD2423F17AD1E156A9093C6 or via Nuvelo's Web site at www.nuvelo.com. << snip Cheers, Tuck