Clinical Trials

Overview:

To date, Sangart's clinical program with MP4OX has enrolled 1026 subjects in 8 completed studies. These include two phase I studies in healthy volunteers, a phase II study in urologic surgery, two phase II studies in orthopedic surgery, a pilot phase II study in vascular patients with critical limb ischemia, and two large multicenter phase III studies in orthopedic surgery. These phase III studies have provided a valuable safety data set in a homogeneous surgical patient population, which has established the expected adverse event profile for MP4OX. In all of the completed clinical studies, 548 subjects were randomized to receive MP4OX, of which 504 received MP4OX at doses ranging from 100 mL to 1000 mL. For the control groups in these studies, a total of 478 subjects were randomized, of which 444 received either crystalloid (Lactated Ringers or Ringer's acetate) or colloid (Voluven, a commercial starch-based plasma expander) infusions.

Currently, Sangart is pursuing a clinical development program to evaluate MP4OX in trauma patients suffering from lactic acidosis due to severe hemorrhagic shock. This therapeutic area will better utilize the unique attributes of the MP4OX molecule to enhance perfusion and target oxygen delivery to ischemic tissues and reverse lactic acidosis, which have been demonstrated in a number of preclinical animal models.

Summaries of the key findings from the 8 completed clinical studies and a brief description of the new phase IIa trauma protocol (study MP4OX-09-TRA-204) are provided below.

Trauma Studies:

Status: 1 study enrollment completed

Study TRA-204 (Europe and S. Africa). A phase IIa double-blind, randomized, controlled, multi-center, dose-finding safety and efficacy study of MP4OX plus standard of care in trauma patients with lactic acidosis due to hemorrhagic shock. (Enrollment initiated December 2009).
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Surgical Studies:

Status: 5 studies completed

Study 6084 (Europe). A phase III double-blind, randomized, controlled, multi-center study of the efficacy and safety of MP4OX, compared with colloid (Voluven®) for prevention of perioperative hypotension in patients undergoing primary hip arthroplasty with spinal anesthesia. (Enrollment completed June 2008).
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Study 6090 (Europe). A phase III double-blind, randomized, controlled, multi-center study of the efficacy and safety of MP4OX, compared with colloid (Voluven®) for treatment of perioperative hypotension in patients undergoing primary hip arthroplasty with spinal anesthesia. (Enrollment completed April 2008).
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Study 6055 (Sweden). A phase II double-blind, randomized, controlled, multi-center safety and efficacy study of MP4OX in orthopedic surgery patients. (Enrollment completed March 2005).
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Study 3002 (Sweden). A phase Ib/II single blind, controlled, increasing dose safety study of MP4OX in orthopedic surgery patients under spinal anesthesia. (Enrollment completed June 2006).
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Study 6012 (USA). A phase II single-blind, randomized, controlled, dose-escalation safety study of MP4OX in surgical patients undergoing radical prostatectomy. (Enrollment completed September 2007).
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Ischemia Studies:

Status: 1 study completed

Study 6034 (Sweden). A phase II single-blind, randomized, controlled pilot study of MP4OX in patients with chronic critical limb ischemia (CCLI). (Enrollment completed May 2008).
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Healthy Volunteer Studies:

Status: 2 studies completed

Study 6108 (Sweden). A phase I single-blind, randomized, ascending dose pharmacokinetic (PK) study of MP4OX in healthy male volunteers. (Enrollment completed October 2007).
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Study 3001 (Sweden). A phase I single-blind, placebo-controlled, rising dose safety and tolerance study of MP4OX in healthy volunteers. (Enrollment completed May 2002).
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