Nuvelo Announces Successful Results in Phase I Clinical Trial
Thursday March 27, 11:32 am ET
The Company Plans to Initiate Phase II Trials in Both PAO and Catheter Occlusion in the First Half of 2003
SUNNYVALE, Calif., March 27 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO - News), formerly Hyseq Pharmaceuticals, today announced positive Phase I results with its lead product candidate, alfimeprase, for the treatment of peripheral arterial occlusion (PAO).
Enrollment in the multi-center, open-label, dose-escalation study to evaluate the safety and pharmacokinetics of alfimeprase, was completed in twenty patients across seven centers in the United States. The results show that alfimeprase was safe and well-tolerated. There were no drug related adverse events.
Based on the positive results from this Phase I trial, Nuvelo plans to rapidly initiate a Phase II trial in acute PAO patients. In addition, Nuvelo filed an investigational new drug (IND) application for a second indication, catheter occlusion. This IND was accepted by the Food and Drug Administration (FDA) and Nuvelo plans to initiate a Phase II program in this indication as well. Both trials are expected to begin enrollment in the first half of this year.
"The Phase I study is an important step in establishing the safety of alfimeprase," stated Dr. Ted W. Love, president and chief executive officer of Nuvelo. "We are extremely pleased with the results and are ready to initiate both of our Phase II programs. In these trials we should begin to see clear patient benefit in the safe and rapid dissolution of clots in both PAO and catheter occlusion and we expect to complete at least one of these Phase II 'proof-of-concept' programs by the end of 2003."
Dr. Kenneth Ouriel, chairman of the department of vascular surgery at the Cleveland Clinic and principal investigator of the Phase I study, and Dr. Timothy Murphy, associate professor of diagnostic imaging at Brown University Medical School, will both discuss alfimeprase at the Society for Interventional Radiology (SIR) Annual Meeting March 27-April 1, 2003. Nuvelo expects to present the clinical trial data in either a journal publication or at a medical conference later 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 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 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 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 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.
About Catheter Occlusion
Catheter occlusion is a major complication affecting central venous catheters and can impair the ability to infuse fluid through, or withdraw fluid from the catheter. When a catheter becomes occluded, the ultimate goal is to restore patency 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. These include: limited interruption of therapy, reduced risk of trauma to the patient, reduced risk of complications and decreased cost. In the case of thrombolytic occlusions, treatment with thrombolytic drugs represents a less-invasive and more cost-effective alternative to replacement. Currently, urokinase and alteplase are approved for restoring function to central venous access devices.
About Nuvelo
Nuvelo, Inc., formed by the merger of Hyseq Pharmaceuticals, Inc. and VARIAGENICS, Inc., is engaged in the discovery and development of novel therapeutics. Nuvelo's lead product candidate, alfimeprase, is partnered with Amgen and is scheduled to enter two Phase II trials in the first half of 2003 in both peripheral arterial occlusion and catheter occlusion. Additional programs include drug discovery focused on immunotherapeutics and secreted proteins.
Information about Nuvelo is available at our new website at www.nuvelo.com or by phoning 408-215-4000.
Statements contained in this press release which are not historical in nature, are intended to be, and are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "believe," "expect," "anticipate," "should," "may," "estimate," "goals," and "potential," among others. 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, the risk that we may not successfully integrate the VARIAGENICS business following our recent merger, uncertainties relating to drug discovery, clinical development processes and the development and commercialization of our molecular diagnostics technology; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection and regulatory approval; and uncertainties relating to our ability to obtain substantial additional funds required for progress in drug discovery and development. These and other factors are identified and described in more detail in Nuvelo, Hyseq and VARIAGENICS filings with the SEC, including without limitation our respective Annual Reports on Form 10-K for the year ended December 31, 2001, Hyseq and VARIAGENICS most recent quarterly reports on Form 10-Q, and the joint proxy statement/prospectus filed in connection with the merger. We disclaim any intent or obligation to update these forward-looking statements.
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Source: Nuvelo, Inc. |
