Brest University Hospital and Hemarina, a biotech company based in Brittany, announced today they have successfully topped the 100 people involved in OxyOp2 clinical study, which contributes to the clinical development of HEMO2life® universal oxygen carrier.
OxyOp2 is a multicentric clinical trial, including 460 patients. Half of them will receive a kidney graft preserved in a standard solution including HEMO2life®, the other half a sole standard solution, preserving method being drawn by lot. The study started in July of this year and all kidney transplant centers in France will be involved. A total of 11 centers have been selected to deal with the conditioning of donor kidneys applying one of the two tested methods at random. All other kidney transplant centers in metropolitan France and Reunion Island, according to the allocation of grafts decided by the French Agency of Biomedicine, can therefore receive a kidney conditioned as part of this study. To date, more than 100 patients were involved in this clinical trial.
This clinical trial follows the success of the OxyOp1 trial, which proved the safety of HEMO2life® and gave preliminary results regarding efficacy in applications for preserving grafts in cold ischemia, thanks to the oxygenation solution provided by Hemarina’s M101 molecule. Positive results from this first study were published this year in the American Journal of Transplantation (Le Meur et al., 2020, 40, 1729-1738).
“The success of this study in graft preservation, the key arena of transplantation, confirms the potential of HEMO2life®, which contains M101, a molecule permitting the transport of physiological oxygen and its delivery without oxidative stress to organs. I also would like to thank all the transplant coordination teams who work in the shadows, as close as possible to the families and to surgical teams, whose work is essential for this study” underlines Franck Zal, founder and CEO of Hemarina. He adds: “The M101 oxygenating molecule is truly a technological platform, as oxygen is at the center of all physiological processes, and of life itself. We have demonstrated that this molecule is capable of oxygenating cells, tissues, organs and organisms as a whole. We recently presented our work to the teams of Sir Peter J. Ratcliffe, 2019 Nobel Prize laureate in Medicine, who underlined its consistency with their work and the interest of improved organ and tissue oxygenation with HEMO2life®, which would reduce inflammation in comparison with classic solutions and would increase their lifespan”
“This trial carries great hope for the transplantation community, who is waiting for a product to significantly improve performance and transplant lifespan” affirms Professor Yannick Le Meur, head of Nephrology-Kidney Transplantation at the Brest University Hospital (CHRU de Brest) and coordinating investigator. He adds “For the first time, with HEMO2life®, we believe we have a tool which will preserve transplants in greatly improved conditions. In truth, to bring physiological oxygen at this exact moment in conservation, called cold ischemia, is to bring great hope for all transplants. We are very pleased, despite the difficult current context of the hospital environment, to have found at the Brest University Hospital (CHRU de Brest) and other transplant centers, motivated teams who have confidence in this product.”
“We have been working with Hemarina at the Salpétriêre hospital for ten years, in pre-clinical and clinical contexts, on products to improve graft preservation. M101 is a molecule we know well, in which we have faith and which we have been following for many years.” explains Professor Benoît Barrou, head of the Urology-Nephrology-Kidney Transplant service at la Pitié-Salpétriêre Hospital (AP-HP) and co-investigator on this study. He continues “Improved preservation of transplants is a main development focus for transplantation. A preserved transplant with improved physiological oxygenation is higher quality and will extend the lifespan of the transplant in the transplanted patient.”
The OxyOp2 trial is expected to last up to 30 months. The medical world’s growing interest for HEMO2life® could reduce this delay. Results of the assessment of this medical solution will focus on resumed function of the transplant and the calculation of the medico-economic advantages it provides (easier transport, longer preservation, decrease of post-transplant dialysis, speedier return to home, etc.).