Navigation Links
Nuvelo Begins Phase 2 Trial and Receives Fast Track Status for Alfimeprase in Patients With Acute Ischemic Stroke
Date:12/12/2007

SAN CARLOS, Calif., Dec. 12 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO) today announced dosing of the first patient in a Phase 2 proof-of-concept trial of alfimeprase for the treatment of acute ischemic stroke.

Nuvelo has also been granted fast track designation by the U.S. Food and Drug Administration (FDA) for alfimeprase in this indication. Fast track designation, which was mandated by the FDA Modernization Act of 1997, can potentially facilitate expedited review of a Biologics License Application (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.

The Phase 2 CARNEROS-1 (Catheter Directed Alfimeprase for Restoration of Neurologic Function and Rapid Opening of Arteries in Stroke) proof-of-concept trial is a multi-center, open-label, two part, dose escalation (1 mg, 5 mg and 10 mg) study that will enroll approximately 100 patients within 3-9 hours of stroke onset. CARNEROS-1 is designed to evaluate the safety and efficacy of intra-arterial, catheter-directed, bolus alfimeprase. The primary efficacy endpoint is recanalization, or unblocking, of the primary arterial occlusive lesion within 120 minutes of treatment with alfimeprase. Safety will be assessed, including the rate of symptomatic intracerebral hemorrhages at 24 hours.

"We believe that a safer, more efficacious intra-arterial therapy can change the treatment paradigm for stroke patients and that a product candidate such as alfimeprase holds the potential to restore flow rapidly and expand the current treatment window for this underserved patient population," said Michael Levy, M.D., executive vice preside
'/>"/>

SOURCE Nuvelo, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Nuvelo Re-Initiates SONOMA-3 Trial of Alfimeprase in Patients With Catheter Occlusion
2. Nuvelo Announces Alfimeprase SONOMA-2 Catheter Occlusion Data Presentation Webcast and Conference Call
3. Par Pharmaceutical Begins Shipment of Additional Dosage Strength of Generic TOPROL-XL(R)
4. MacroGenics Begins Global Phase 2/3 Protege Study in Recent-onset Type 1 Diabetes Mellitus
5. Enrollment Begins on Human PK Study for Medidur(TM) FA
6. Vical Begins Phase 1 Trial of DNA Vaccine Against H5N1 Pandemic Influenza
7. Sucampo Pharmaceuticals, Inc. Begins Pivotal Phase III Studies of Oral Lubiprostone to Treat Opioid-Induced Bowel Dysfunction (OBD)
8. Rockwell Medical Technologies, Inc. Begins Patient Enrollment for its SFP Dose-Ranging Study
9. Metabolex Begins Phase 2 Trial of MBX-8025 for Treatment of Dyslipidemia
10. DiObex Begins Dosing Patients in Phase 2b Trial of Type 2 Diabetes Drug
11. Rockwell Medical Technologies, Inc. Begins Dosing Patients for SFP Phase IIb Clinical Study
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/28/2015)... and PITTSBURGH , Aug. ... ) today announced that its shareholders have approved ... PRGO ; TASE) and the related issuance ... an extraordinary general meeting of shareholders held today. ... cast at the extraordinary general meeting. In addition, ...
(Date:8/28/2015)... LONDON , August 28, 2015 ... approach seamlessly connects people, technologies and care protoc ... improving outcomes and the cost of healthcare delivery   ... PHIA) today announced its presence at  ESC Congress 2015 , where ... Model A.I. , EchoNavigator and IntelliSpace Cardiovascular, that connect people ...
(Date:8/27/2015)... 27, 2015 DURECT Corporation (Nasdaq: DRRX ... at three upcoming healthcare conferences.  , ... present at the Rodman & Renshaw Investment Conference on ... conference is being held at the St. Regis Hotel ... live audio webcast of the presentation will be available ...
Breaking Medicine Technology:Mylan Shareholders Overwhelmingly Approve Proposed Acquisition of Perrigo 2Mylan Shareholders Overwhelmingly Approve Proposed Acquisition of Perrigo 3Mylan Shareholders Overwhelmingly Approve Proposed Acquisition of Perrigo 4Mylan Shareholders Overwhelmingly Approve Proposed Acquisition of Perrigo 5Mylan Shareholders Overwhelmingly Approve Proposed Acquisition of Perrigo 6Mylan Shareholders Overwhelmingly Approve Proposed Acquisition of Perrigo 7Mylan Shareholders Overwhelmingly Approve Proposed Acquisition of Perrigo 8Mylan Shareholders Overwhelmingly Approve Proposed Acquisition of Perrigo 9Philips Showcases New Integrated Cardiology Solutions to Advance Minimally Invasive Procedures at ESC Congress 2015 2Philips Showcases New Integrated Cardiology Solutions to Advance Minimally Invasive Procedures at ESC Congress 2015 3Philips Showcases New Integrated Cardiology Solutions to Advance Minimally Invasive Procedures at ESC Congress 2015 4DURECT to Participate in Upcoming Healthcare Conferences 2
...  Digestive Care, Inc. (DCI), announced that the company ... approval of its New Drug Application (NDA) for ... Insufficiency (EPI) due to cystic fibrosis (CF) or ... unique pancreatic enzyme product containing bicarbonate-buffered enteric-coated microspheres ...
... May 18, 2012  Ocera Therapeutics Inc., a privately-held ... of proprietary agents to treat gastrointestinal and liver ... CE Mark for Zysa™ (spherical carbon adsorbent, formerly ... (IBS-d), a condition affecting 10-15% of the Western ...
Cached Medicine Technology:Digestive Care, Inc. Announces FDA Approval of PERTZYE™ (pancrelipase) Delayed-Release Capsules 2Ocera Therapeutics receives CE Mark for Zysa™ for the treatment of diarrhea-predominant Irritable Bowel Syndrome (IBS-d) 2Ocera Therapeutics receives CE Mark for Zysa™ for the treatment of diarrhea-predominant Irritable Bowel Syndrome (IBS-d) 3
(Date:8/28/2015)... ... August 28, 2015 , ... The 6th Annual Survivor ... Aneurysm Foundation has added yet another accolade to its cadre of widespread support—an official ... , “With the help of the medical community and the University of Illinois at ...
(Date:8/28/2015)... ... August 28, 2015 , ... Loved ones ... personally be struggling with chemical dependency, may be able to find some hope ... results-driven holistic treatment center for addiction located in Western Michigan. Focusing on several ...
(Date:8/28/2015)... (PRWEB) , ... August 28, 2015 , ... “ Frequentz ... look at the latest and coolest applications on the market for iOS, Android, and ... and shared with viewers how this software allows businesses to track product movement from ...
(Date:8/28/2015)... FL. (PRWEB) , ... August 28, 2015 , ... ... for businesses nationwide. Addictions specialist, Dr. James Strawbridge, gives a new approach on ... that it should begin with the employer and employees getting together for meaningful ...
(Date:8/28/2015)... TN (PRWEB) , ... August 28, 2015 , ... ... recipients of the Veterans Award, honoring military veterans leading in business. Mr. ... honorees. , The inaugural Nashville Business Journal's 2015 Veterans Awards will ...
Breaking Medicine News(10 mins):Health News:Chicago Mayor Pens Official Support of Annual Survivor in the City Event Benefitting Brain Aneurysm Foundation 2Health News:Chicago Mayor Pens Official Support of Annual Survivor in the City Event Benefitting Brain Aneurysm Foundation 3Health News:Best Drug Rehabilitation Releases New Video Outlining Patients' Personal Recovery Stories 2Health News:Best Drug Rehabilitation Releases New Video Outlining Patients' Personal Recovery Stories 3Health News:Track Product Movement from Beginning to End with Frequentz 2Health News:MyGenetx Board Member Receives Veterans Award 2
... US researchers have discovered a non-invasive elastography technique that ... to radiation. ,The technique found by ... measuring muscle noise to reveal a patients condition. ... 16 sensors, each 1.5 centimetres apart, along the thigh ...
... Huxley has said that, "Although there was support for a ... of heart disease , the relationship is not as strong ... may have on heart disease are dwarfed by other risk ... ,Coronary heart disease is the leading cause ...
... who are hard of hearing. But the authorities have hardly ... problem has mysteriously persisted for decades in the Muslim-dominated Jhumarvad ... ,Shamshool Mia, a 62-year-old villager, said: "I am hard ... treatment failed to cure me. I will have to suffer ...
... public support for the fight against kidney diseases was kicked ... from the marathon, hosted by the New York Road Runners ... Arab Emirates (UAE), will go to the US National Kidney ... entrants from around the world, including 1000 women, 29 runners ...
... suspects in police custody is standard operating procedure for ... the idea that using a Taser could lead to ... the final results of a study conducted by emergency ... (UCSD) Medical Center showed no lasting effects of the ...
... Even before women with breast cancer undergo chemotherapy, ... activity levels, according to a new study ... in Omaha, Nebraska. ,Researchers say their ... following breast cancer surgery and before any further ...
Cached Medicine News:Health News:The Plight of Jharkhand's Mysterious deaf Village 2Health News:Healthy Humans Not Harmed By Taser 2Health News:Research Suggests Breast Cancer Fatigue Begins Before Chemo 2Health News:Research Suggests Breast Cancer Fatigue Begins Before Chemo 3
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
Medicine Products: