SAN CARLOS, Calif., Dec. 9 /PRNewswire-FirstCall/ -- Nuvelo, Inc. today announced results from the Phase 3 SONOMA-2 (Speedy Opening of Non-functional and Occluded catheters with Mini-dose Alfimeprase-2) trial (N=303), demonstrating that alfimeprase, the company’s lead product candidate, actively restored catheter function and was well-tolerated in patients with catheter occlusion (CO). These data were presented yesterday in a poster session by Stephan Moll, M.D., associate professor at the University of North Carolina Medical School in Chapel Hill; Department of Medicine, Division of Hematology-Oncology, at the American Society of Hematology (ASH) 49th Annual Meeting, in Atlanta, GA. A webcast will be held Monday, December 10th at 4:30 p.m. ET to review these data.
“There is an unmet need for a safe and rapid thrombolytic,” said Dr. Moll. “Afimeprase could offer a new treatment option for thrombotic-related disorders such as CO due to its potential ability to keep activity direct and localized.”
Results from the SONOMA-2 trial show that alfimeprase restored catheter function in patients with occluded catheters within 15 minutes in 34.3 percent of patients in the alfimeprase group versus 21.6 percent in the placebo group (p=0.022). While alfimeprase restored catheter function in a greater number of subjects than placebo, it did not meet its primary endpoint by achieving a p-value of less than or equal to 0.00125 at 15 minutes. At 30 minutes post first or second infusion, catheter function was restored in 52.7 percent of patients treated with alfimeprase versus 30.4 percent in the placebo group (p=0.0002). Rates of adverse events (65.8 percent alfimeprase, 59.4 percent placebo), serious adverse events (15.5 percent alfimeprase, 16.8 percent placebo), and hemorrhagic adverse events (3.6 percent alfimeprase, 10.9 percent placebo) were comparable between treatment groups. No intracranial hemorrhages were observed. Cardiac-related events were reported at a higher rate in the alfimeprase group (6.7 percent) than the placebo group (2.0 percent), however analysis indicated that this was attributed to an imbalance in the distribution of subjects with heart disease at baseline.
“The SONOMA-2 trial results reinforce evidence that alfimeprase is an active and well-tolerated thrombolytic with the potential to quickly dissolve clots and rapidly restore catheter function,” said Michael Levy, M.D., executive vice president of research and development for Nuvelo. “We are currently enrolling patients in the SONOMA-3 trial to evaluate whether a higher and more concentrated dose of alfimeprase will improve clot dissolution rates while maintaining the favorable risk benefit profile seen in SONOMA-2. We look forward to sharing top-line data from this trial in the first half of 2008.”
Preclinical experiments have provided evidence of increased alfimeprase activity at higher concentrations. Nuvelo is currently enrolling patients in the SONOMA-3 trial. This open-label, single-arm trial evaluates the safety and efficacy of a single 10 milligram dose of alfimeprase with a concentration of 5 milligrams per milliliter in up to 100 patients with occluded central venous catheters.
SONOMA-2 Study Details
SONOMA-2 was a multi-center, multi-national, randomized, double-blind, placebo-controlled Phase 3 study evaluating the efficacy and safety of alfimeprase in subjects with occluded catheters. Subjects were randomized in a 2:1 ratio to receive either 3.0 milligrams of alfimeprase or placebo. Study drug was delivered in a total volume of 2 milliliters. If catheter function was not restored within 30 minutes, a second dose of the same study drug was given and allowed to dwell for an additional 30 minutes. Re-establishment of catheter function was assessed by an attempt to withdraw 3 milliliters of blood and infuse 5 milliliters of saline. The primary efficacy endpoint was restoration of catheter function at 15 minutes post first infusion. The pre-specified p-value for this endpoint was less than or equal to 0.00125.
Webcast Call Information
Nuvelo will hold a conference call Monday, December 10th at 4:30 p.m. Eastern Time to discuss this presentation. To participate in the conference call, please dial 866-854-8095 for domestic callers and 706-634-8567 for international callers and reference conference passcode 26513597. A telephone replay of the conference call will be available through Monday, December 24, 2007. To access the replay, please dial 800-642-1687 for domestic callers and 706-645-9291 for international callers and reference conference passcode 26513597.
In addition, this call is being webcast by Thomson/CCBN and can be accessed via Nuvelo’s website at http://www.nuvelo.com. The webcast is also being distributed through the Thomson StreetEvents Network. Individual investors can listen to the call at http://www.earnings.com, Thomson’s individual investor portal, powered by StreetEvents. Institutional investors can access the call via Thomson StreetEvents (http://www.streetevents.com), a password-protected event management site.
About Catheter Occlusion
Delivery of chemotherapy, nutritional support, antibiotics and blood products, as well as the frequent withdrawal of blood samples for laboratory testing, are often facilitated via central venous catheters. Approximately five million catheters are placed in patients in the United States each year, with as many as 25 percent becoming occluded. When a catheter becomes occluded, the goal is to restore flow in a prompt and cost-effective manner with minimal risk to the patient. As these catheters are primarily inserted in patients receiving life-saving medications such as chemotherapy, it is critical to restore flow through the catheter as soon as possible. In the case of thrombotic occlusions, treatment with thrombolytic drugs represents a less-invasive and more cost-effective alternative to replacement.
About Alfimeprase
Alfimeprase is a recombinant direct acting fibrinolytic (rDAF) that has the potential to rapidly dissolve blood clots through a unique mechanism of action -- it directly degrades fibrin, a protein that provides the scaffolding for blood clots. In addition, alfimeprase’s thrombolytic activity appears to be localized to the site of delivery because it is rapidly inactivated by alpha-2 macroglobulin, a naturally occurring protein in the blood, as it moves away from the site of delivery and into the general blood circulation.
In addition to catheter occlusion, alfimeprase is also being evaluated as a potential treatment for acute ischemic stroke.
About Nuvelo
Nuvelo, Inc. is dedicated to improving the lives of patients through the discovery, development and commercialization of novel drugs for acute cardiovascular disease, cancer and other debilitating medical conditions. Nuvelo’s development pipeline includes alfimeprase, a direct acting fibrinolytic in Phase 2 clinical development for the treatment of thrombotic-related disorders including acute ischemic stroke and catheter occlusion; and preclinical candidates NU206 for the potential treatment of chemotherapy/radiation therapy-induced mucositis and inflammatory bowel disease and NU172, a direct thrombin inhibitor for use as a potential short-acting anticoagulant during medical or surgical procedures. In addition, Nuvelo expects to continue its research programs in leukemia therapeutic antibodies and Wnt signaling pathway therapeutics 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 timing and progress of Nuvelo’s clinical stage and research programs, the potential benefits that patients may experience from the use of our clinical stage compounds, 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; stock market conditions; the impact of competitive products and technological changes; and uncertainties relating to our ability to obtain funding. These and other factors are identified and described in more detail in Nuvelo’s filings with the SEC, including without limitation Nuvelo’s quarterly report on Form 10Q for the quarter ended September 30, 2007 and subsequent filings. We disclaim any intent or obligation to update these forward-looking statements.
CONTACT: Lee Bendekgey, SVP, CFO and General Counsel of Nuvelo, Inc.,
+1-650-517-8358, lbendekgey@nuvelo.com; or Danielle Bertrand of WeissComm
Partners, +1-415-946-1056, dbertrand@wcpglobal.com, for Nuvelo, Inc.
Web site: http://www.nuvelo.com/
