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Effective and Safe Blood Substitutes: An Attainable Reality or Lost Cause?

Effective and Safe Blood Substitutes: An Attainable Reality or Lost Cause?. Jonathan S. Jahr, MD Professor of Clinical Anesthesiology David Geffen School of Medicine at UCLA. Disclosure Statement. Hemosol Incorporated: Principle Investigator in two Phase II Trials, Speakers Bureau.

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Effective and Safe Blood Substitutes: An Attainable Reality or Lost Cause?

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  1. Effective and Safe Blood Substitutes: An Attainable Reality or Lost Cause? Jonathan S. Jahr, MD Professor of Clinical Anesthesiology David Geffen School of Medicine at UCLA

  2. Disclosure Statement Hemosol Incorporated: Principle Investigator in two Phase II Trials, Speakers Bureau. Biopure Corporation: Principle Investigator in two Phase II/III Trials, Speakers Bureau. Alliance Corporation: Principle Investigator in Phase I Trial.

  3. Risks of Allogeneic Blood Transfusions • American Society of Anesthesiologists Practice ParametersPractice Guidelines for Perioperative Blood Transfusion and Adjuvant Therapies: An Updated Report by the American Society of Anesthesiologists Task Force on Perioperative Blood Transfusion and Adjuvant Therapies.1 1 Anesthesiology 2006; 105(1):198

  4. Accepting Minimal Hemoglobin Levels • Acceptable Hemoglobins of 5 g/dL? • Weiskopf et al. Human cardiovascular and metabolic response to acute, severe isovolemic anemia. JAMA 1998;279:217-21.

  5. Ideal Characteristics of a Blood Substitute • Jahr, et al. Am J Ther 2002. Winslow, Semin Hematol 2007

  6. Methods of Preparation of Modified Hemoglobin Solutions • Fromm, Crit Care Medicine 2000. Chang, Biotech Annu Rev 1998

  7. MODEL OF AN HBOC WITH RAFFINOSE IN THE 2-3 DPG POSITION (HEMOGLOBIN RAFFIMER)

  8. Clinical Trials of HBOCs Clinical Phase I, II, and III trials with Biopure's Hemopure, Hemosol's Hemolink, and Alliance's Perflubron have produced useful data, although both Hemosol and Alliance have not pursued these products, probably due to poor study designs in cardiac surgery models, and lack of cooperation with independent investigators (refusal to publish existing data, etc).1,2 1 Levy JH, Goodnough LT, Greilich PE, Parr GVS, Stewart RW, Gratz I, Wahr J, Williams J, Comunale ME, Doblar D, Silvay G, Cohen M, Jahr JS, Vlahakes GJ. Polymerized bovine hemoglobin solution as a replacement for allogeneic red blood cell transfusion after cardiac surgery: Results of a randomized, double-blind trial. The Journal of Thoracic and Cardiovascular Surgery 2002, 124:35-42. 2 Jahr JS, Mackenzie C, Pearce B, Pitman A, Greenburg AG. HBOC-201 as an alternative to blood transfusion: efficacy and safety evaluation in a multicenter phase III trial in elective orthopedic surgery. Journal of Trauma-Injury Infection & Critical Care 2008; 64(6):1484-1497.

  9. BIOPURE’S HEMOPURE • Approved for clinical anemia in South Africa in 2001 • Under FDA and UK review • Phase III Pivotal Study published • Efficacy proven, safety studied • Jahr, et al. J Trauma, 2008. Jahr, et al. Expert Opinion in Bio Ther, 2008

  10. Northfield Laboratories’ POLYHEME • Phase III Study completed, presented only in abstract form • FDA submission, 4th quarter 2008 • Studied as resuscitation fluid, not oxygen therapeutic • Jahr, et al. I Drugs, 2004. www.northfieldlabs.com, accessed on 9/23/08

  11. SANGART’S HEMOSPAN • Phase II Trials completed. • Phase III Trials in EU completed. • Use of product for hypotension in spinal anesthesia for orthopedic surgery. • P50 = 6 mmHg • Hb = 5 g/dL • Viscosity www.sangart.com, accessed 9/23/08

  12. Future HBOCs • Oxyvita available in lyophylized form • Hemosol Biopharma HRC 101 • Jahr, et al. J Cardiothorac Vasc Anesth, 2008. Crawford, et al. Anesthesiology, 2007

  13. Meta-Analysis A recent meta-analysis has compared mortality and morbidity of the current products (Hemopure, PolyHeme, and Hemospan and older discontinued products, Hemolink and HemeAssist) not to primary or secondary endpoints, but to mortality, all derived from post-hoc subset data analysis.1,2 1 Natanson C, Kern SJ, Lurie P, et al. Cell-free hemoglobin-based blood substitutes and risk of myocardial infarction and death: a meta-analysis. JAMA 2008; 299(19):2304-2312. 2 Greenburg AG. Biopure refutes the JAMA meta-analysis - June 6, 2008, www.biopure.com/, accessed 9/17/2008.

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