CAMBRIDGE, Mass., Jan. 27 /PRNewswire-FirstCall/ -- A University of California clinical investigator today reported study results from one of the medical centers that participated in Biopure Corporation's pivotal Phase III clinical trial of Hemopure(R) [hemoglobin glutamer - 250 (bovine), or HBOC-201]. The results, from UC Davis Medical Center in Sacramento, Cal., were reported as a poster presentation at the Society of Critical Care Medicine's 31st Annual Congress in San Diego, Cal. The Phase III trial is a multinational, randomized, red blood cell controlled, single-blind, parallel-group study designed to assess Hemopure as an alternative to allogeneic red blood cell transfusion in patients undergoing elective orthopedic surgery. 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 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." Site Results 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 (measures of renal function) showed no clinically significant differences in the two treatment groups from baseline to the six-week follow up. Median serum enzyme levels for lipase (a pancreatic enzyme), aspartate transaminase and alanine transaminase (liver enzymes) were also similar for both treatment groups. Median troponin levels (a measure of cardiac ischemia) 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 (MedDRA coded) that occurred in more than 10 percent of the Hemopure-treated patients (> or = 2 patients) included anemia (low red blood cell count), abdominal distension, constipation, diarrhea, dyspepsia (heartburn), ileus (intestinal inflammation), nausea, vomiting, chest pain, fatigue, inadequate analgesia (pain relief), edema (fluid retention), pyrexia (fever), weakness, increased lipase, muscle spasms, pain in limb, dizziness, headache, hypoaesthesia (reduced sensitivity to stimuli), insomnia, anxiety, hematuria (blood in urine), oliguria (low urine output), urinary retention, decreased breath sounds, dyspnea (shortness of breath), hypoxia (oxygen deprivation), wheezing, pruritis (itchiness), 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 (ECG), 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. Study Design 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). Biopure Corporation Biopure Corporation (Nasdaq: BPUR), headquartered in Cambridge, Mass., is a leading developer, manufacturer and supplier of a new class of pharmaceuticals, called oxygen therapeutics, which are intravenously administered to deliver oxygen to the body's tissues. Hemopure(R) [hemoglobin glutamer - 250 (bovine), or HBOC-201] is approved in South Africa for the treatment of adult surgical patients who are acutely anemic and for the purpose of eliminating, reducing or delaying the need for allogenic red blood cells in adult surgical patients. The company is preparing to file a marketing application for Hemopure in the United States, followed by an application in Europe, for perioperative use of the product in patients undergoing elective surgery. The product is also being developed for use in trauma, cancer and ischemic events such as heart attack and stroke. Oxyglobin(R) [hemoglobin glutamer - 200 (bovine), or HBOC-301], the only product of its kind approved by the U.S. FDA and the European Commission, is commercially available in the United States, Germany, France and the United Kingdom for the treatment of anemia in dogs. Statements in this press release that are not strictly historical may be forward-looking statements. There can be no assurance that Biopure Corporation will be able to commercially develop its oxygen therapeutic products, that necessary regulatory approvals will be obtained, that anticipated milestones will be met in the expected timetable, that any clinical trials will be successful, or that any approved product will find market acceptance and be sold in the quantities anticipated. Actual results may differ from those projected in forward-looking statements due to risks and uncertainties that exist in the company's operations and business environment. These risks include, without limitation, the company's stage of product development, history of operating losses and accumulated deficits, and uncertainties and possible delays related to clinical trials, regulatory approvals, possible healthcare reform, manufacturing capacity, marketing, market acceptance, competition and the availability of sufficient financing to support operations. The company undertakes no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof. A full discussion of Biopure's operations and financial condition, and specific factors that could cause the company's actual performance to differ from current expectations, can be found on the company's website at www.biopure.com/corporate/legal/home_legal.htm and in the company's filings with the U.S. Securities and Exchange Commission, which can be accessed in the EDGAR database at the SEC website, www.sec.gov, or through the Investor section of Biopure's website, www.biopure.com. SOURCE Biopure Corporation CONTACT: Douglas Sayles, Director, Corporate Communications of Biopure Corporation, +1-617-234-6826, or [email protected]; or Media - Brad Miles of BMC Communications, +1-212-477-9007, ext. 17, or Investors - Lee Stern of The Trout Group, +1-212-477-9007, ext. 16, both for Biopure Corporation/ |
