Hemosol Inc., of Etobicoke, Ontario, has submitted an investigationalnew drug (IND) application to the FDA and Canada's Bureau ofBiologics for its first human red blood cell substitute, Hemolink. Pre-clinical trials were completed in January, and the company hopes tobegin human clinical trials this summer.The market for blood substitutes includes surgical procedures, trauma,coronary angioplasty, cancer therapy, drug delivery to organs andtissues, and organ tranplantation.Hemolink is produced by what the company describes as a new highlyefficient and proprietary chromatographic process that results in ahemoglobin product of extremely high purity.Hemosol's process is based on human hemoglobin derived fromoutdated blood. According to Alun Davies, president and chiefexecutive officer, blood that has been stored for 35 days may not beused in hospitals because the red blood cells tend to break down. Usingoutdated blood supplied by the Canadian Red Cross, Hemosol extractsthe hemoglobin from the red blood cells to make its synthetic bloodsubstitute."The degree of purity we have achieved through our proprietaryprocess is greater than we have seen elsewhere," Davies said. "This iscrucial, because large volumes of this material are used and a onepercent impurity can cause serious effects."The company says that Hemolink has several advantages over wholeblood or red blood cells. These include universal compatibility withblood groups, extended storage capability, and greater assurance offreedom from viruses such as HIV or hepatitis."We know that we can keep Hemolink at frozen temperatures for along time. We hope to show that it can keep for at least six months,"Davies said. "We are also looking at freeze drying. However, theproblem is that large quantities of Hemolink are needed and freezedrying is very expensive. We don't see this an option for theforeseeable future."Davies said Phase I trials of Hemolink will be done in Montreal,Canada. Phase II trials will be conducted in both the United States andCanada.Hemosol is also developing a second blood substitute technology basedon the acyl phosphate ester class of cross-linkers discovered by RonaldKluger of the University of Toronto and licensed to Hemosol. n
-- Philippa Maister
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