OPK Biotech’s research strategy focuses on the development of our products as an oxygen bridge solution or treatment to help stabilize patients and prevent tissue damage or organ dysfunction associated with oxygen deprivation. The pre-clinical and clinical research has shown our products may be beneficial due to its rapid release of oxygen and small molecular size in ischemic conditions where there is a shortage of oxygen due to decrease or lack of red blood cell flow to an organ or area of the body due to obstructed or constricted blood vessels. The Company is currently assessing the products' safety and feasibility in such conditions.
Victims of trauma may have massive bleeding resulting in rapid loss of blood volume and oxygen-carrying capacity. Patient blood typing and blood handling requirements, particularly refrigeration, limit the feasibility of using red blood cell transfusions in pre-hospital emergency treatment. To stabilize blood pressure in these patients, emergency caregivers administer intravenous fluids, such as Lactated Ringer's Solution or saline. Both of which restore blood volume, but do not restore oxygen-carrying capacity. Our products’ oxygen-carrying capacity may provide time for the patient to be transported successfully to where blood and better care is available.
Organs for transplant are harvested and maintained chilled without any oxygen supply, leading to organ ischemia. Perfusion with our product, used for its oxygen-carrying ability, may eliminate or reduce organ ischemia, maintaining a viable organ for improved patient outcomes and allowing for a greater window of time to get a healthier organ to the recipient.
Our human product is contra-indicated in patients who have:
Allergies to bovine hemoglobin;
Pregnant or lactating females;
And in patients younger than 18 years of age.
Risks associated with the administration of our product
In the human clinical trials, AEs that occurred in our product group at greater than or equal to 5% increased incidence compared with the control group included:
Transient yellow skin discoloration (not associated with liver dysfunction)
Mild to moderate increase in blood pressure (10 to 20 mm/hg)
Low urine output
Low red blood cell count
These AEs were generally transient and manageable
Cardiovascular events occurring in < 2% of patients treated with our product include angina, arterial thrombosis, myocardial ischemia, myocardial infarction, and congestive heart failure.
The following events, which are also expected sequelae of surgical procedures, were seen in clinical trials with our human product: asthenia (fatigue/weakness), chills, edema, fever, headache, post-operative pain (incisional), arrhythmias (including atrial fibrillation), bradycardia, decreased blood pressure, elevated blood pressure, tachycardia, abdominal gas, constipation, diarrhea, ileus, nausea, vomiting, hypocalcaemia, hypokalemia, hypomagnesaemia, confusion, decreased mental activity, insomnia, (bi)basilar crackles/rales, decreased breath sounds, arterial desaturation, hypoxemia, respiratory insuffiency/hypercarbia, sore throat, itching, rash, wound drainage, difficulty urinating/oliguria and hematuria.
Care should be taken while administering our product, which is an isosmotic colloid solution and acts as a plasma volume expander. As with any colloid, avoidance of circulatory overload is an important consideration, and patients who are at risk for adverse effects from fluid administration should be carefully monitored.
Although clinical trial data have not conclusively demonstrated adverse effects in patients with heart failure, these patients should be assessed for fluid overload particularly during and after the administration of doses exceeding 60 grams in one day. Concomitant administration of other colloids (such as plasma and hetastarch) should be undertaken with caution to avoid fluid overload.