Annexin A5 has been tested for safety and efficacy in numerous disease models both in vitro and in vivo. Several of these studies were conducted by leading researchers independent of the Company.
Studies show that Annexin A5:
– plays a protective role against inflammation and rupture of atherosclerotic plaques, which are considered to lead to myocardial infarction, stroke and complications in the circulation in the legs.
– displays a very clear desirable effect when used as a treatment for vascular damage and vascular inflammation in animal models.
– has dampening effects on an overactive immune system within the blood vessels, leading to an anti-inflammatory effect of direct relevance to vascular diseases.
– has been shown to be able to interrupt the ongoing sickle cell crisis in an animal model of the disease, in acute treatment.
– has demonstrated significant desired effect in blood cell studies from patients with central retinal vein occlusion.
– when delivered to damaged cells, repairs up to 85% of them.
(The effect of Annexin A5 treatment on inflamed vessel after 3 weeks in mouse. Placebo (A) and with Annexin A5 (B). Ewing et al.)
The Company collaborates with a number of research groups in an early-stage research project testing the use of ANXV in contagious viral diseases, such as ebola. These diseases are associated with extensive damage throughout the cardiovascular system. Annexin’s research project aims at simultaneously attacking the spread of the virus and improving the patient’s own defenses (endothelial, coagulation and immunology based) to reduce suffering and hopefully mortality. Additionally, the Company intends to study the efficacy of ANXV in the treatment of other rare vascular diseases, for example hemolytic diseases where smaller vessels are affected.
Annexin A5 is not yet used to treat any disease. Since Annexin A5 has a particular ability to seek out damaged cells and bind to their surface, this property is already used in patients for radiological imaging of recently damaged and dying cells in blood vessels and in the heart, and in conjunction with cancer treatment, where the protein’s capability to seek out and color damaged cells is used. Using radioactively-labeled Annexin A5, studies in Europe and the United States were conducted in approximately 435 patients, with no adverse side effects. The Annexin A5 used for diagnostics is labeled, and the amount of protein injected in patients is very small and is not expected to reach the doses expected to achieve therapeutic effect. Another area where the pharmaceutical industry hopes to benefit from Annexin A5’s ability to act as a targeting protein, is its use as a tool for delivering drugs to damaged cells, so called drug delivery.