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| |  SCCM: Hemopure (HBOC-201) Shows Promise as Alternative to Red Blood Cell Transfusion in Elective Orthopedic Surgery CAMBRIDGE, MA -- January 28, 2002 -- A Phase III clinical trial of Hemopure® [hemoglobin glutamer - 250 (bovine), or HBOC-201] shows positive efficacy, safety and tolerability as an alternative to allogeneic red blood cell transfusion in patients undergoing elective orthopedic surgery, according to a University of California investigator. The results, from UC Davis Medical Center in Sacramento, California, were reported as a poster presentation at the Society of Critical Care Medicine's (SCCM) 31st Annual Congress in San Diego, California. The Phase III trial is a multinational, randomized, red blood cell-controlled, single-blind, parallel-group study. The data from UC Davis represent 35 of the 688 patients treated in the trial. The two hypotheses of the poster presentation are that at least 35 percent of patients receiving Hemopure will avoid red blood cell transfusion for up to six weeks post surgery and that the safety and tolerability issues of Hemopure in this patient population are similar to those of patients receiving red blood cells. "At our site, Hemopure was well tolerated, eliminated the need for red blood cell transfusion in about half of the patients who received the product and significantly reduced overall blood usage compared to the control group," said Jonathan S. Jahr, M.D., the principal investigator at UC Davis during the trial who is now professor of anesthesiology and Director of clinical research at the UCLA Department of Anesthesiology. "I'm optimistic that these results may support this compound's use as an oxygen 'bridge' in elective surgery patients who are acutely anemic, although the sample size at our site was too small to draw definitive conclusions. I look forward to reporting more comprehensive data at upcoming medical meetings beginning in March." Of the 35 patients enrolled at UC Davis, 19 received Hemopure and 16 received allogeneic red blood cells. Results show an avoidance of red blood cell transfusions in 47 percent of the Hemopure-treated patients (n=9) at 42 days post surgery, 58 percent (n=11) at one week post surgery and 100 percent (n=19) on the day of surgery. The mean number of red blood cell units administered in the Hemopure group (1.3 units) was significantly smaller than in the control group (3.1 units). The two groups had similar median total hemoglobin levels and median hematocrit levels (red blood cell volume as a percentage of blood volume) at the time of discharge from the hospital and at the six-week follow-up time point. The hemodynamic results showed transient, slight to modest increases in blood pressure in the Hemopure group compared to the red blood cell control group. The largest mean increase in mean arterial pressure (MAP) during the entire six-week follow-up period was 15.5 mm/Hg in the Hemopure group and 6.2 mm/Hg in the control group. Mean changes in MAP from pre-treatment to 30 minutes following the first infusion were similar in the Hemopure group (10.3 mm/Hg + or - 4.5) and the red blood cell control group (15.7 mm/Hg + or - 8.7). As expected in this surgical patient population, the clinical chemistry parameters fluctuated over time. Median blood urea nitrogen and creatinine values showed no clinically significant differences in the two treatment groups from baseline to the six-week follow up. Median serum enzyme levels for lipase, aspartate transaminase and alanine transaminase were also similar for both treatment groups. Median troponin levels in the Hemopure group remained within the normal range. Because of the small sample sizes, medians rather than means were used to describe data. Adverse events that occurred in more than 10 percent of the Hemopure-treated patients (more than or equal to two patients) included anemia, abdominal distension, constipation, diarrhea, dyspepsia, ileus, nausea, vomiting, chest pain, fatigue, inadequate analgesia, edema, pyrexia, weakness, increased lipase, muscle spasms, pain in limb, dizziness, headache, hypoaesthesia, insomnia, anxiety, hematuria, oliguria, urinary retention, decreased breath sounds, dyspnea, hypoxia, wheezing, pruritis, postoperative pain, and wound drainage. Adverse events that occurred in more than 10 percent of the red blood cell patients included constipation, nausea, vomiting, exacerbated pain, increased cardiac enzymes, abnormal electrocardiogram, back pain, muscle spasms, hypoaesthesia, insomnia, anxiety, cough, pruritis, postoperative pain, and wound drainage. There were no deaths in either patient group at this site. Patients were randomized (1:1) to receive either Hemopure or allogeneic blood at the first transfusion decision. Patients randomized to the Hemopure group received an initial dose of two units of Hemopure and, if needed, up to eight additional units within the next six days. Patients requiring transfusion outside of these parameters were subsequently administered allogeneic blood and were not included in the blood avoidance totals. Control group patients received only standard transfusions of allogeneic blood. To date, Hemopure has been administered to more than 800 patients in 22 completed or ongoing clinical trials at doses up to 36 units. One unit of Hemopure contains 30 grams of ultrapurified, chemically cross-linked hemoglobin in 250 milliliters of a balanced salt solution. This cross-linked hemoglobin circulates in the plasma when infused, and has a lower viscosity and more readily releases oxygen to tissues than blood. Hemopure is uniquely stable at room temperature for three years, is compatible with all blood types, and is purified through patented techniques that are validated to remove infectious agents, including bacteria, viruses, and the agents that are thought to cause transmissible spongiform encephalopathies (TSE). SOURCE: Biopure Corporation
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