Clinical Trials

Overview:

To date, Sangart's clinical program with MP4OX has enrolled 1,078 subjects in 9 completed studies. These include two phase 1 studies in healthy volunteers, a phase 2 study in urologic surgery, two phase 2 studies in orthopedic surgery, a pilot phase 2 study in vascular patients with critical limb ischemia, two large multicenter phase 3 studies in orthopedic surgery and a recently completed phase 2a study in trauma. The previous phase 3 studies in hip replacement surgery have provided a valuable safety data set in a homogeneous low-risk surgical patient population, which has established the adverse event profile for MP4OX. In the 9 completed clinical studies, a total of 537 treated subjects have received doses of MP4OX ranging from ~100 mL up to 1,000 mL, and 462 subjects (Controls) have received volume-matched infusions of crystalloids or colloid solutions.

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, which have been demonstrated in a number of preclinical animal models, of enhancing perfusion and targeted oxygen delivery to ischemic tissues and reversal of lactic acidosis.

In addition, Sangart is pursuing a clinical development program to evaluate MP4CO in patients with sickle cell disease. MP4CO could alleviate the acute pain suffered by patients in sickling crises by delivering therapeutic, non-toxic levels of CO to cells and tissues, and stabilizing abnormal hemoglobin-S. After delivering the CO, the MP4 molecule is oxygenated in the lung and then continues to circulate as MP4OX and deliver oxygen to ischemic tissues.

Summaries and key findings from the 9 completed clinical studies and brief descriptions of ongoing and planned studies are provided below.

Trauma Studies:

Status: 1 study completed; 1 study ongoing

Study TRA-204 (Europe and S. Africa). A phase 2a 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 completed June 2010).
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Study TRA-205 (Worldwide, non-US). A phase 2b multi-center, randomized, double-blind, controlled study to evaluate the safety and efficacy of MP4OX treatment, in addition to standard treatment, in severely injured trauma patients with lactic acidosis due to hemorrhagic shock. (Enrollment initiated June 2011).
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Sickle Cell Studies:

Status: 1 study being initiated

Study SCD-105 (France, Jamaica and UK). A multi-center, randomized, double blind, dose escalation safety study of MP4CO in clinically stable adult sickle cell patients. (Enrollment expected to begin Q4 2011)

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Surgical Studies:

Status: 5 studies completed

Study 6084 (Europe). A phase 3 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 3 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 2 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 1b/2 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 2 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 2 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 1 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 1 single-blind, placebo-controlled, rising dose safety and tolerance study of MP4OX in healthy volunteers. (Enrollment completed May 2002).
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