Navigation Links
Preliminary Data From Experimental Study Demonstrate Increased Mortality in Stroke Patients Treated With Epoetin Alfa

BRIDGEWATER, N.J., Sept. 17 /PRNewswire/ -- Ortho Biotech has become aware of preliminary data from an investigator-initiated experimental study of the effects of Epoetin alfa in patients with acute ischemic stroke. In this study, patients suffering acute ischemic stroke who were treated with Epoetin alfa within six hours of the onset of stroke symptoms died more frequently than patients receiving placebo. Ortho Biotech has reported this information to the U.S. Food and Drug Administration and to European regulatory authorities. Additional analyses are underway to better understand these preliminary results.

Epoetin alfa is marketed as EPREX(R) / ERYPO(R) outside the U.S. by Janssen-Cilag, as PROCRIT(R) in the U.S. by Ortho Biotech and as EPOGEN(R) in the U.S. by Amgen. None of these products are approved in any country for use in patients with acute ischemic stroke. Epoetin alfa is a member of the class of erythropoiesis-stimulating agents (ESAs). ESAs should be used strictly in accordance with their approved indications and dosing recommendations.

This investigator-initiated experimental study was designed and conducted by an investigator in Europe. Ortho Biotech provided study drug and funding, but the company had no role in designing or conducting the study. The investigator has informed the company that the results of this study will be submitted for publication promptly.

SOURCE Ortho Biotech
Copyright©2008 PR Newswire.
All rights reserved

Page: 1

Related medicine technology :

1. Trubion Announces Preliminary Analysis of Phase IIb Results With TRU-015 in Rheumatoid Arthritis
2. Genomic Health Announces Preliminary Results From a Study of Oncotype DX(TM) in Node-Positive Breast Cancer Patients
3. Preliminary Results of Randomized Pilot Study Show Comparable Efficacy for OrbusNeichs Genous(TM) Bio-engineered R Stent(TM) and Boston Scientifics Taxus(R) Stent in Patients at High Risk of Restenosis
4. Sunesis Pharmaceuticals Reports Preliminary SNS-595 Activity in Ovarian Cancer Clinical Trial at AACR-NCI-EORTC International Conference
5. Pharmion and MethylGene Report Preliminary MGCD0103 Clinical Data at the 2007 AACR-NCI-EORTC International Conference
6. Keryx Biopharmaceuticals, Inc. Announces Positive Preliminary Phase 2 Data on KRX-0401 in Patients with Chemo-Insensitive Rare Sarcoma
7. Vion Pharmaceuticals To Present Preliminary Data on its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) at the American Society of Hematology Meeting
8. Pixantrone Versus Doxorubicin in CHOP-R Therapy for First-line Treatment of Aggressive Non-Hodgkins Lymphoma Preliminary Results Presented at American Society of Hematology (ASH) Annual Meeting
9. Anthera Announces Preliminary Positive Results From Once-Daily A-002 Phase II Cardiovascular Trial
10. Morria Biopharmaceuticals Plc Announces Preliminary Safety and Tolerability Results From Its Phase I Clinical Study of MRX-4 in Allergic Rhinitis Patients
11. A Functional Immune System Can Be Derived From Embryonic Stem Cells, Preliminary Study Finds
Post Your Comments:
(Date:6/23/2016)... HOUSTON , June 23, 2016  MedSource ... platform as its e-clinical software solution of choice.  ... the best possible value to their clients by ... nowEDC.  The preferred relationship establishes nowEDC as the ... pricing for MedSource,s full-service clients.  "nowEDC has long ...
(Date:6/23/2016)... 23, 2016 Any dentist who has made an ... current process. Many of them do not even offer this ... and high laboratory costs involved. And those who ARE able ... such a high cost that the majority of today,s patients ... Parsa Zadeh , founder of Dental Evolutions Inc. and ...
(Date:6/23/2016)... a startling report released today, National Safety Council research ... proven plan to eliminate prescription opioid overdoses. Prescription Nation ... tackling the worst drug crisis in recorded U.S. history, assigned a ... , New Mexico , Tennessee ... failing states, three – Michigan , ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... 2016 , ... "FCPX editors can now reveal their media with growing colorful ... Christina Austin - CEO of Pixel Film Studios. , ProSlice Color brings the ... can now reveal the media of their split screens with growing colorful panels. , ...
(Date:6/26/2016)... ... 2016 , ... Quality metrics are proliferating in cancer care, and are derived ... eye of the beholder, according to experts who offered insights and commentary in the ... Care. For the full issue, click here . , For the American Society ...
(Date:6/26/2016)... , ... June 26, 2016 , ... ... once they have been diagnosed with endometriosis. These women need a treatment plan ... require a comprehensive approach that can help for preservation of fertility and ultimately ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... First ... United States, named Dr. Sesan Ogunleye, as the Medical Director of its new Mesquite-Samuell ... facility Medical Director of our new Mesquite location,” said Dr. James M. Muzzarelli, Executive ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article published June 14 ... The article goes on to state that individuals are now more comfortable seeking to ... operations such as calf and cheek reduction. The Los Angeles area medical group, Beverly ...
Breaking Medicine News(10 mins):