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
FOR FURTHER INFORMATION CONTACT:
Sophia H. Twaddell
Vice President, Corporate Communications
|SOURCE Northfield Laboratories Inc.|
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