Clinical Trials Resource Center

New Medical Therapies™

Blood Transfusions

November 7, 2005

Sangart issued positive results of a phase II trial of Hemospan (MP4), their hemoglobin-based oxygen carrier under investigation as a synthetic substitute for blood transfusions during surgical procedures. Efficacy data indicated significantly lower rates of hypotension in the two Hemospan groups vs. the control group (46%, 42% for low- and high-dose groups respectively, vs. 87% for control; p<0.025). Mean heart rate was also significantly lower for both Hemospan groups (p<0.02). A non- significant trend was observed in rates of intraoperative vasopressor use (17%, 13% vs. 32%). This randomized, controlled study enrolled 90 patients undergoing hip arthroplasty across 6 sites in Sweden, who received either 250 ml or 500 ml of Hemospan or a control solution (Ringer's acetate) prior to the procedure.

June 6, 2005

Inspire Pharmaceuticals has issued positive results of a phase I trial of INS50589 Antiplatelet, for the prevention of platelet aggregation during blood transfusion. Results from the study yielded a positive safety profile, with no serious adverse events reported. Pharmacokinetics were dose dependent and in keeping with preclinical models. Biological activity was also observed, with statistically significant decreases in platelet aggregation at all doses, and complete inactivation of aggregation at the three highest doses, within 15-30 minutes of administration. Platelet aggregation returned to normal following discontinuation of infusion. This single center study enrolled sequential cohorts of healthy volunteers: the first cohort of 12 subjects was treated in an open-label fashion, while the second cohort of 24 subjects was treated in a double-blind, placebo-controlled arm. Following these results, the company announced plans to conduct a pre-clinical proof-of-concept study in an animal model of cardiopulmonary bypass surgery in Q3 2005.

June 28, 2004

Synthetic Blood International has reported positive phase I results for Oxycyte, their synthetic perfluorocarbon (PFC) blood substitute. Results have shown the drug to be safe and well tolerated, in keeping with preclinical results; furthermore, it’s adverse events profile is seen as significantly improved compared with competing PFC products. The study found that the most frequent adverse events noted among the 6 participants were mild flu-like symptoms, including nausea, vomiting, minor fever and headache; incidences ranged from 16.7% to 33.3% of subjects (n = 1 to 2). Incidence of these adverse events was much higher in other PFC products, and Oxycyte also did not produce other PFC-related events, including asthenia, anorexia and insomnia. Based on these results, phase II trials are planned for late 2004.

December 16, 2002

Novartis reported positive results from a phase II trial investigating ICL670, an oral iron chelator for the treatment of chronic iron overload resulting from blood transfusions. The average liver iron decrease was greater in subjects treated with 20 mg/kg/day of ICL670 (- 2.2 mgFe/g liver) than those treated with Desferal (-1.2 mgFe/g liver) or 10 mg/kg/day of ICL670 (-0.6 mgFe/g liver). The open-label, randomized, multicenter study enrolled 63 subjects with iron overload resulting from a transfusion treatment of beta-thalassemia. The trial was designed to compare the overall safety, tolerability and efficacy of ICL670 relative to Desferal by measuring decreases in liver iron concentrations (LIC). After nine-months, LIC in 63 subjects taking ICL670 (10 or 20 mg/kg) decreased by 5.61% and 26.3%, respectively, compared with 13.9% of 20 subjects in the Desferal group.

February 4, 2002

UC Davis Medical Center, one of the centers that participated in Biopure's phase III trial of Hemopure (hemoglobin glutamer), has reported positive study results. The multinational, randomized, single-blind, parallel-group phase III trial was designed to assess Hemopure as an alternative to allogeneic red blood cell transfusion in subjects undergoing elective orthopedic surgery. Of the 35 subjects enrolled at UC Davis, 19 received Hemopure and 16 received allogeneic red blood cells. Results from the center showed an avoidance of red blood cell transfusions in 47% of Hemopure-treated subjects at 42 days post-surgery, 58% at one week post-surgery and 100% on the day of surgery.

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