Currently in the clinical testing phase, Diannexin is a drug designed to reduce rejection of transplanted organs. It specifically deals with a problem known as ischemia/reperfusion (I/R) injury, which occurs when an organ is unable to refill itself with blood after being frozen prior to transplant.
A frozen organ is in a state of hypoxia, or lack of oxygen, which causes the blood vessels throughout the organ to undergo ischemia, or a thinning of the blood vessels. When blood suddenly rushes into the organ upon being transplanted, the body overreacts to the ischemic injury and creates an immune response inside the organ. This releases inflammatory factors like cytokines, interleukins and free radicals into the organ, causing reperfusion injury. This further de-oxygenates the transplanted organ, causing more ischemia, which begins a cascade that can lead to the destruction of the transplant organ.
Diannexin is designed to prevent the body's immune system from binding to the transplant organ in the first place, allowing it to become oxygenated and settled in the body without the stress of an immune response exacerbating the ischemia.
Scientists made breakthroughs in research on Diannexin in 2007, when a team from the Dumont-UCLA Transplant Center successfully prevented rat liver transplants from causing I/R injury to the rats. Since then, multiple studies have been done showing that when various organ transplants are treated with Diannexin and when the patient is given the same drug, incidence of I/R injury is significantly reduced for all cases.
It has been proven that Diannexin works to prevent organ rejection as a result of I/R injury. It is currently undergoing trials to prove that it is safe for general use before it can be marketed to transplant hospitals throughout the U.S. and around the world. By 2008, Phase 1 of human clinical trials, designed to test for the safety of the drug, was completed by Alavita Pharmaceuticals. By early 2009, Phase 2a had been completed without incident. However, Diannexin research was halted for about a year while Alavita entered into negotiations with Japanese pharmaceutical company Astellas Pharma. On November 3, 2010, Astellas acquired all of the assets and rights to Diannexin for $5 million. Astellas is currently gearing up to perform Phase 2b clinical trials on Diannexin.
This move is seen by professionals and experts as a good move for organ transplants overall, as Alavita is more of a general pharmaceutical company while Astellas specifically focuses on organ transplant medications. With Astellas at the helm of Diannexin treatment, the future seems bright for organ donors or their families worried about their bodies attacking a donated organ before it can be successfully integrated.