Wageningen, 16 November 2017- Alloksys Life Sciences announced today that its international APPIRED lll clinical study has started with inclusion of the first patient in Eindhoven, the Netherlands.
Patients undergoing invasive surgeries have a high risk of complications from ischemic injury. The objective of APPIRED lll study is to demonstrate that biologic drug candidate RESCAP reduces acute kidney injury during and after open heart surgery. This multi-centre international study has 9 participating institutes across Asia and Europe, with 1250 patients to be recruited. Alloksys aims to propose RESCAP to be applied in cardiothoracic surgery practice upon a successful trial.
Catharina Hospital Eindhoven is one of the largest cardio vascular centre in The Netherlands. Cardiothoracic surgeon Dr. Erwin Tan is leading the trial in Eindhoven. “We have seen the beneficial effects of RESCAP and how it reduces risks for patients during and after open heart surgery in the earlier trials here in Eindhoven. Therefore, we are happy to contribute to this large scale international study to confirm our earlier findings.” he comments.
Prof. Kofidis, Principal Investigator of the APPIRED lll study, states: “Our Intensive Care Unit literally turned into a kidney failure unit over the last few years, that is how complex and high risk our cases have become. We are happy to see the kick start of the APPIRED trial in Eindhoven and look forward to starting patient recruitment at all centres.”
RESCAP (REScuing Alkaline Phosphatase) is a biological therapeutic developed by Alloksys to prevent and treat ischemic injury and inflammation in acute clinical settings. Alkaline Phosphatase is an endogenous protein that is naturally present in the body. It has an important protective role in the immune system. When the body is under ischemic stress, such as caused by open heart surgery, additional Alkaline Phosphatase is needed to prevent onward complications such as inflammation and tissue damage.
About Alloksys Life Sciences
Alloksys Life Sciences is a Dutch company that develops RESCAP (RESCuing Alkaline Phosphatase) as a therapeutic compound for the prevention and treatment of indications associated with acute ischemic injury and inflammation. The company’s lead program is currently in Phase llb/lll clinical trial in cardiothoracic surgery. In addition, the company is investigating application of RESCAP in other major surgery applications and solid organ transplantation.
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