Clinical Trials

Study 6012 – Phase II Prostatectomy Surgery (USA)

Details
This was a phase II randomized, controlled, dose-escalation safety study in 20 surgical patients undergoing radical prostatectomy conducted at Johns Hopkins University Hospital (Baltimore, MD, USA). The primary objective was to evaluate the safety of MP4OX when administered following an estimated surgical blood loss of 250 mL. In addition, transesophageal echocardiographic (TEE) assessments were made to estimate pulmonary artery pressures (PAP) in those patients with measurable tricuspid valve regurgitation where the jet velocity could be measured by TEE. Ten patients ranging in age from 45 to 70 years old (N = 5 MP4OX-treated; N = 5 controls receiving Lactated Ringers [LR] solution) were enrolled in each of 2 dose cohorts (250 mL and 500 mL). [Additional details about the protocol can be found at http://clinicaltrials.gov/ct/show/NCT00425334].

Results

Vital signs and ECG findings: Mean values for blood pressures were similar across groups, but the SBP means in the MP4OX groups tended to be higher than in the LR controls. ECG findings were similar between groups, with no clinically significant abnormalities noted.

TEE findings: A total of 5 MP4OX patients and 3 LR controls had sufficient tricuspid regurgitation to obtain TEE measurements at baseline and post-dosing for calculating pulmonary artery systolic pressure (PASP). With the exception of 1 MP4OX patient (500 mL group), results suggested that there was no trend for increased PASP following MP4OX administration.

Adverse events: There were no deaths, SAEs, or AEs that lead to permanent discontinuation from the study. More control patients experienced at least one AE. Most AEs were determined to be unlikely or not related to investigational product. There were no severe AEs reported in either the MP4OX or the LR group.

Laboratory findings: For most laboratory parameters, means and changes from baseline were similar across all 4 treatment groups. Trends were observed for hematology parameters, showing increases in mean WBC counts and decreases in mean RBC counts and packed cell volumes postoperatively, as expected in surgical patients undergoing major invasive surgical procedures. Most clinical chemistry parameters were similar across the 4 treatment groups.