Lots of interesting ASCO news already. But also this result from Nuvelo (I own a little):
Press Release Source: Nuvelo, Inc.
Nuvelo Announces Preliminary Phase 2 Alfimeprase Results in Acute Peripheral Arterial Occlusion Trial Presented Today at the Vascular 2004 Annual Meeting
Saturday June 5, 6:00 pm ET
SUNNYVALE, Calif., June 5 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News) today announced the presentation of preliminary clinical data from the first 87 patients in its Phase 2 alfimeprase trial in acute peripheral arterial occlusion (PAO), showing that there was a clear dose response, increasing the rate of recanalization as the trial moved from the 0.1 mg/kg dose to the 0.6 mg/kg dose and that alfimeprase was generally safe and well tolerated.
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The preliminary Phase 2 data was presented today in a late breaking session at the Vascular 2004 Annual Meeting in Anaheim, CA. The presentation entitled, "Safety and efficacy of alfimeprase for catheter-directed thrombolysis in patients with acute peripheral arterial occlusion: Interim Phase 2 report (NAPA-1)," was given by Dr. Sean Lyden of the Cleveland Clinic, investigator for Nuvelo's Phase 2 alfimeprase trial for the potential treatment of PAO.
The presentation provided interim clinical data from Nuvelo's multi-center, open-label, dose-escalation Phase 2 study evaluating the safety and efficacy of alfimeprase in patients with acute PAO. Patients were randomized to receive one of three doses of alfimeprase, 0.1 mg/kg, 0.3 mg/kg or 0.6 mg/kg. Doses were administered via a side-hole catheter in two separate, five to fifteen minute pulsed infusions, giving 2/3 of the dose up front, followed by the remaining 1/3 of the dose after two hours. Angiograms were taken at baseline (time zero), one hour and two hours with the final and conclusive angiogram taken at four hours after initial dosing.
Recanalization post baseline was observed in 81% of subjects in the 0.6 mg/kg dose group, 50% in the 0.3 mg/kg dose group and 36% in the 0.1 mg/kg dose group. The overall median time to limb reperfusion was 1.17 hours. Overall, 58% of subjects had a reduced severity of planned medical or surgical procedure and 62% were open-surgery free at 30 days post treatment with alfimeprase.
There were no incidences of intracranial hemorrhage (ICH) and no major bleeding events were unequivocally attributed to alfimeprase. All serious adverse events that were observed were reversible, did not result in any clinical sequelae and were compatible with outcomes observed in other thrombolytic trials.
"Having the potential to decrease treatment times in this very sick patient population from 24 to 36 hours, to less than four hours, is extremely exciting," said Dr. Steven Deitcher, vice president of medical affairs for Nuvelo. "We look forward to continuing to work with this novel thrombolytic as the Company moves into its pivotal Phase 3 trial at the end of this year."
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 and clinical studies have shown alfimeprase to be up to six times faster in dissolving clots. In addition, alfimeprase's novel clearance mechanism dramatically limits the molecule's half-life, reducing the risk of bleeding complications, a common side-effect of current therapies.
Alfimeprase was identified through Amgen's research program and a collaboration with Nuvelo was formed in January 2002 for development and commercialization. Under the terms of the collaboration, Nuvelo will lead all clinical development activities and Amgen will be responsible for manufacturing activities. Amgen will have the option to lead the commercialization efforts in which both companies may participate.
About PAO
PAO is the blocking of arterial blood flow to a distant part 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 PAO is leg pain or fatigue during activity that subsides with rest. Continued restriction of blood flow leads to pain at rest and, if the ischemia continues, to ulcers, gangrene, tissue death and if untreated, 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 approved, widely used products on the market to treat PAO. With the limited treatment options currently available, alfimeprase has received orphan drug designation for the PAO indication.
Phase 2 Alfimeprase Programs
The multi-center, open-label, dose-escalation study evaluating the safety and efficacy of alfimeprase in acute PAO patients is being led by Dr. Kenneth Ouriel, chairman of the division of surgery at the Cleveland Clinic and Dr. Jacob Cynamon, professor of clinical radiology and director of the division of vascular and interventional radiology at the Montefiore Medical Center. This international study is comparing three different doses of alfimeprase in 115 patients across 24 centers in the United States, Europe and South Africa.
Nuvelo is also currently conducting a Phase 2 trial to evaluate the safety and efficacy of alfimeprase in a second indication, catheter occlusion. This multi-center, randomized, double-blind study began in June 2003 and is comparing three doses of alfimeprase against the approved dose of t-PA (alteplase). The study is being conducted in approximately 100 patients across 32 centers in the United States.
About The Vascular 2004 Annual Meeting
The Vascular 2004 Annual Meeting held June 3 - 6, 2004 will be a historic event where four prominent vascular associations will come together for the first time to create the world's premier event for specialists in vascular disease. The Society for Vascular Ultrasound (SVU), the Peripheral Vascular Surgery Society (PVSS), and the Society for Vascular Medicine and Biology (SVMB) will meet in conjunction with the Society for Vascular Surgery (SVS).
About Nuvelo
Nuvelo, Inc. is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo's lead product candidate, alfimeprase, is being developed in collaboration with Amgen and is currently in two Phase 2 trials in two indications, peripheral arterial occlusion and catheter occlusion. Additional programs include cardiovascular product candidates ARC183 and rNAPc2 and drug discovery focused on antibody targets and secreted proteins.
Information about Nuvelo is available at our new Web site at www.nuvelo.com or by phoning 408-215-4000.
So this drug is doing in about an hour what normally takes 24 hours, with what looks like a lower incidence of bleeding to boot - that would expand the market, as right now this type of treament (using Reteplase) seems to be reserved for the most serious cases because of worries about causing a intracranial bleed.
Peter |
