Biopure

Research Areas

Ischemia

Ischemia - a decrease or lack of red blood cell flow to an organ or area of the body due to obstructed or constricted blood vessels, as in heart attack, stroke and certain medical procedures.

Our development strategy for ischemia is to conduct clinical trials of Hemopure to assess the product's safety and feasibility in ischemia indications, such as cardiac surgery, wound healing and acute coronary ischemia (e.g. heart attack). In contrast to previous trials where Hemopure was administered as a red blood cell replacement, in these trials Hemopure is being administered as an oxygen-carrying drug.

Anemia

Anemia - a decrease in the concentration of red blood cells or hemoglobin in circulation caused by blood loss for example, from injury or surgery, or by other causes, such as disease or chemotherapy treatment.

Surgical Anemia Marketing Application

In November 2007, Biopure submitted a complete response to the UK's Medicines and Healthcare products Regulatory Agency (MHRA) questions, arising from our marketing authorization application (MAA), submitted in July 2006. Biopure is seeking MHRA authorization to market Hemopure in the U.K. for acute anemia, following orthopedic surgery blood loss when blood is not readily available or not an option.

Additional Anemia Research

The Company has also decided to draw on the body of research it has amassed in preclinical and clinical studies involving anemia in surgery patients to develop new indications. Thus, the Company is assessing the feasibility of two other possible trials.

Palliative Care: One possible trial would examine Hemopure's potential, owing to its oxygen-carrying capacity, to increase perfusion and improve the quality of life in patients with advanced life-limiting illness. The study would measure, using well established methods, both quantitative and qualitative outcomes. Anemia is a significant but understudied problem in terminally ill patients. In a recent study of 105 palliative care patients, of whom 95 had advanced cancer, anemia was found in 77% of men and 68% of women.

Erythropoietic Agent: Another possible trial would examine the potential erythropoietic effect of Hemopure as an alternative to or in conjunction with erythropoietin stimulating agents (ESAs) such as the marketed drugs Aranesp or Procrit, which enhance the production of red blood cells. Recently the FDA has required a label warning about the use of ESAs, and reported sales of those products have declined. In the Phase 2 post-cardiopulmonary bypass clinical trial described above, which compared the post operative use of Hemopure to donated red blood cells in cardiac surgery, the hematocrit, or packed red blood cell volume as a percentage of total blood volume, was similar for both the Hemopure-infused and the red blood cell-infused patients on the sixth day following surgery. Both groups maintained this similarity when measured again at the follow-up visit 28 days after surgery. A red blood cell transfusion infuses red blood cells into the patient's blood stream. An infusion of Hemopure does not. Consequently, the similarity of red blood cell volume in both groups of patients suggests that Hemopure may promote the regeneration of red blood cells. The use of Hemopure as an erythropoietic agent is also supported by at least one Biopure preclinical study. The proposed Hemopure study would collect safety and preliminary efficacy data. Biopure has observed evidence in previous clinical trials that Hemopure may have such an effect. This would be our first clinical trial to test the hypothesis.

Trauma

Trauma - a decrease in blood volume from a serious or critical bodily injury, wound, or shock.

In trauma situations, victims may have massive bleeding resulting in rapid loss of blood volume and oxygen-carrying capacity. Blood typing and handling requirements, particularly refrigeration, limit the feasibility of using red blood cell transfusions in pre-hospital emergency treatment. Existing alternatives to red blood cell transfusions are limited. In an effort to stabilize trauma patients, emergency caregivers typically administer commonly used intravenous fluids, such as Ringer's lactate or saline. Ringer's lactate consists of water and electrolytes and generally is administered into the veins of patients who have lost substantial amounts of bodily fluids as a result of bleeding, vomiting or diarrhea. Both Ringer's lactate and saline restore blood volume, but do not carry oxygen.

If the safety and effectiveness of Hemopure in trauma patients experiencing acute blood loss in the out-of-hospital setting can be demonstrated to the FDA's satisfaction, we believe that the product's multi-year room temperature stability, universal compatibility and other properties could allow it to be stockpiled, positioned abroad, and carried or stored in remote locations. These attributes may make it well-suited for use on the battlefield, in ambulances, and in the Strategic National Stockpile, which is a store of medicines kept by the U.S. Center for Disease Control in case of public health emergency.

Research agreement with US Navy

The U.S. Navy agreed to buy Hemopure and seven different modifications of Hemopure for preclinical testing. Biopure formulated and manufactured the modified versions of Hemopure to test hypotheses concerning changes in formulation in relation to physiological effects. The Navy has made grants to eight institutions for testing the modifications and is conducting research at Navy facilities with Navy preclinical investigators. Based on information to date, all of which is interim, we do not anticipate that these modifications will supplant Hemopure.