Northfield Laboratories Inc. Comments on Article and Editorial on Hemoglobin-Based Blood Substitutes to be Published in May 21 J
April 28 2008 - 12:05PM
PR Newswire (US)
EVANSTON, Ill., April 28 /PRNewswire-FirstCall/ -- Northfield
Laboratories Inc. (NASDAQ:NFLD). Northfield Laboratories Inc.
issued the following statement in response to a May 21 publication
in the Journal of the American Medical Association entitled
Cell-Free Hemoglobin-Based Blood Substitutes and Risk of Myocardial
Infarction and Death: A Meta-analysis and the accompanying
editorial released online today. "Meta-analyses that compare varied
products under the umbrella of an entire class are a useful tool to
raise questions that may merit answers with respect to the class,"
said Steven A. Gould, M.D., Chairman and Chief Executive Officer of
Northfield Laboratories, Inc. "But it is important to note what
meta-analyses cannot accomplish. Meta-analysis is not designed to
provide answers about specific products or to examine fully the
risk/benefit ratio of any particular product. Rather, that is the
role of clinical trials that are focused on a particular product
and are conducted to assess its safety and efficacy in relation to
a proposed indication. Northfield will present such data on its
product, PolyHeme(R) next week at the FDA/NIH-sponsored workshop on
Hemoglobin Based Oxygen Carriers (HBOCs.)" The workshop, sponsored
jointly by the Food and Drug Administration and the National
Institutes of Health, will be held on April 28 and 29 in Bethesda,
Maryland. It will examine the current status and future directions
of HBOCs. Steven A. Gould, M.D., will present a talk on the
clinical development of PolyHeme(R), Northfield Laboratories'
investigational red cell substitute. His talk will include a
summary of the clinical studies conducted by the Company and
reported to the FDA. About the Workshop The two-day public
workshop, Hemoglobin-Based Oxygen Carriers: Current Status and
Future Directions, is sponsored by the Food and Drug
Administration, the National Heart, Lung and Blood Institute of the
National Institutes of Health, and the Department of Health and
Human Services' Office of the Secretary and Office of Public Health
and Science (OS/OPHS). The purpose of the workshop is to gather the
available scientific information and hear informed opinion on the
safety of HBOCs in relation to a variety of clinical use settings
as a basis to advance the field. About Northfield Laboratories and
PolyHeme(R) Northfield Laboratories Inc. is a leader in developing
an oxygen-carrying red blood cell substitute for the treatment of
life-threatening blood loss, when an oxygen-carrying fluid is
required and red blood cells are not available. Northfield's
product, PolyHeme(R), is under clinical investigation as
oxygen-carrying red blood cell substitute. It is a solution of
chemically modified human hemoglobin that requires no cross
matching and is therefore compatible with all blood types. It has a
shelf life in excess of 12 months. For further information, visit
http://www.northfieldlabs.com/. FOR FURTHER INFORMATION CONTACT:
Sophia H. Twaddell Vice President, Corporate Communications (847)
864-3500 DATASOURCE: Northfield Laboratories Inc. CONTACT: Sophia
H. Twaddell, Vice President, Corporate Communications of Northfield
Laboratories Inc., +1-847-864-3500, Web site:
http://www.northfieldlabs.com/
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