Sister Company AMRIF readying up for clinical trial in chronic inflammatory disease

AMRIF, Alloksys’s sister company is readying up for trials in several chronic inflammatory disease applications. First of these are a study in RA patients, based on excellent results with hRESCAP in a first and only animal model for arthritides. Please see www.AMRIF.eu and publication Chandrupatla DMSH,et al 2018 Prophylactic and therapeutic activity of alkaline phosphatase in arthritic rats: single-agent effects of alkaline phosphatase and synergistic effects in combination with methotrexate.Transl Res. 2018 Sep;199:24-38. doi: 10.1016/j.trsl.2018.04.001. Epub 2018 May 17.

Approval for Solid Organ Transplantation Study

Approval has been obtained in October 2018 to start with a solid organ transplantation study with RESCAP platform technology under supervision of PI Dr Joost van der Heijden from Vumc Amsterdam. First patient in status will likely be in January 2019. Ischemic injury in kidneys to be transplanted are cause of serious complications and limit overall success rate of transplantation. With RESCAP we expect to reduce overall SIRS complication s peri-and post surgery and expect to improve patients well being following surgery.

Clinical Data APPIRED I and APPIRED II are basis for breakthrough Computational model that clarifies immune response during cardiac surgery

Computational model clarifies immune response during cardiac surgery

11 October 2018

A research team led by Peter Sloot, professor of Complex Adaptive Systems at the UvA, has managed to pinpoint the mechanisms behind the immune response triggered in patients undergoing open heart surgery. The team’s research reveals that by administering supplementary enzymes, so-called alkaline phosphates, to patients undergoing cardiac surgery, the latter can regain control over their own immune response. This in turn results in a surprisingly shorter recovery time and a considerably higher survival rate. The team’s results were recently published in the leading open-access journal Frontiers in Immunology.

Since the origin of life about 3.8 billion years ago, various life forms have sought ways to protect themselves at a cellular level against invading pathogens. In those earliest life forms and in humans today, attacks by bacteria, fungi and viruses are repelled by an innate immune system. Over the course of millions of years, the co-evolution of the immune system and pathogens has resulted in a highly complex, extremely reactive and efficient immune system. Although this has enabled the survival of life, there are instances when a reactive immune response can have detrimental consequences. A notorious example is during surgery, when the immune system goes into overdrive by delivering an acute inflammatory response. A specific group of enzymes, alkaline phosphates, play a surprising role in this phenomenon – besides detoxifying the body, these enzymes are responsible for ensuring the barriers in our body, such as the gut and blood-brain barrier, continue to function normally. Whenever detoxification fails or the barrier functions are lost, complications arise in the form of an acute immune response with possibly disastrous consequences. Sloot and his team have unravelled this process with the help of a computational model and clinical research.

Better for the patient and for the healthcare sector

‘The computational model allows us to predict both before and during surgery how the patient will react to the attack on his or her immune system’, says co-author Ruud Brands, molecular cell biologist at Utrecht University and president of Alloksys Life Sciences Ltd. ‘The attending cardiothoracic surgeon can then take proactive measures to prevent the patient’s condition from deteriorating, which can also have negative long-term implications. Not only is this better for the patient, but in the long run also contributes to cost savings in healthcare.’

An infinite number of interactions

‘It was a long and arduous road’, says Sloot. ‘The immune system is a truly complex system, one with an infinite number of interactions and feedback mechanisms. It often exhibits unpredictable behaviour at the edge of order and chaos. This new computational model is therefore not merely an algorithm you can unleash on a mountain of data. Quite the opposite. It is an exceptionally thorough first attempt at genuinely gaining a deeper understanding of the underlying processes. It is thanks to the efforts and determination of the entire team of computational scientists, biologists and mathematicians that we’ve been able to gain this vital insight.’

Publication details

Alva Presbitero, Emiliano Mancini, Ruud Brands, Valeria V. Krzhizhanovskaya & Peter M.A. Sloot: ‘Supplemented Alkaline Phosphatase Supports the Immune Response in Patients Undergoing Cardiac Surgery: Clinical and Computational Evidence’, in: Frontiers in Immunology (11 October 2018). DOI: 10.3389/fimmu.2018.02342

Dec 2018 APPIRED III

APPIRED III study is getting well on its way with 6 centres started with including patients. These centres are Singapore NUH, CZE Eindhoven, Jessa, Hasselt, UniMed Wien Vienna, Almazov Heart Centre St Petersburg and IJN Kuala Lumpur. Up to 10 other sites await either local or governmental approval

Alloksys Life Sciences BV Obtains 3.4 million EURO Innovation Credit

Alloksys Life Sciences BV, a biopharma SME based in The Netherlands, has been granted an Innovation Cedit (’Innovatiekrediet’) of 3.4 million EUR by the Netherlands Enterprise Agency for the execution of Phase 3 clinical trials leading to registration of RESCAP® (RESCuing Alkaline Phosphatase*) for the prevention and treatment of ischemic injury and inflammation mediated complications in cardiothoracic surgery (APPIRED III).

ICM Pharma invests €5.25 million in Alloksys Life Sciences to support Phase 3 clinical study trials of RESCAP® drug

Dutch based Alloksys Life Sciences BV has signed and closed agreements with the fastest growing local pharmaceutical company in Singapore, ICM Pharma,Pte. Ltd. to invest €5.25 million (approximately S$8.1 million) for a minority stake in Alloksys and an exclusive license to market and produce RESCAP® (RESCuing Alkaline Phosphatase*) for prevention and treatment of ischemic injury and inflammation mediated complications in cardiothoracic surgery in Asia.