A1M Pharma’s research has shown that the kidneys are amongst the organs which are best protected by the A1M protein. We have therefore devoted resources to developing treatments for acute kidney injury, which is a condition that affects 12 million people each year. Our primary focus at present is on adjuvant treatment alongside PRRT, which you can read more about below.

Protecting the kidneys is vital
In addition to being the body’s waste disposal units, the kidneys are also a control centre for blood pressure regulation and thus also the body’s salt and fluid balance. This means that impaired kidney function affects virtually all bodily functions.

In parallel with their studies of pre-eclampsia, Bo Åkerström’s and Stefan Hansson’s research groups at Lund University have investigated the effect of oxidative stress in cultured kidney cells and in the kidneys of laboratory animals. On analysis of the kidney tissue, these experiments have shown unexpectedly positive results. In both cases it is clear that A1M appears to have protective and healing properties. Extended studies are now under way to confirm A1M’s therapeutic effects and to identify renal diseases where these effects may be of help. These studies are being conducted in Lund and in cooperation with other institutions.

Acute injury to kidney tissue and impaired kidney function can, for example, arise as a result of poisoning and infections, as well as in conjunction with major bleeding, lack of oxygen and certain types of cancer treatment. Kidney injuries can also be caused by diabetes, high blood pressure and glomerulonephritis, which is an inflammatory condition in which the kidney’s filters – the glomeruli – become damaged. In all these cases oxidative stress is an important contributory factor to the damage. If the damage is extensive, chronic kidney failure can result, requiring dialysis or a kidney transplant.

ROSgard can support cancer treatment (PRRT)

PRRT (Peptide Receptor Radionuclide Therapy) is a form of targeted cancer treatment used to treat neuroendocrine tumours (NET), which tend to develop in the lungs or the stomach or bowels. A side effect of treating these tumours is damage to the kidneys caused by oxidative stress. For this reason, treatment of the cancer is restricted, because the dose must be adjusted to reflect the risk of kidney damage.

Preliminary data following the conclusion of a long-term preclinical trial with an animal model clearly indicates that the active substance in the drug candidate ROSgard provides strong kidney protection when administered in connection with radiation therapy. Clinical trials are scheduled to begin in early 2018. A1M Pharma’s objective is to be able to administer ROSgard at each radiation therapy session in order to protect the kidneys and potentially increase the efficacy of treatment. The market for kidney protection in connection with treatment of neuroendocrine tumours is estimated to be worth approx. USD 200–500 million.

The way forward
Plans for the clinical Phase I/II trials are under way, and a Contract Research Organisation partner will be chosen during the third quarter of 2017. The Phase I/II trials are scheduled to begin during the first quarter of 2018. The Phase I/II trials will commence with a safety study in healthy volunteers, followed by safety and efficacy studies in sick patients. For more information, see the timetable.
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