Morlaix, Brest (France), 26 November 2020 – 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.).
About kidney transplants
Kidney transplants are currently the only treatment for end-stage renal failure. It allows patients whose kidneys have been destroyed by illness to renew hope of near normal quality of life. The average lifespan for a transplant is approximately 15 years. In 2019, of 5 901 total transplantations carried out in France, 3 643 were kidney transplantations. As of January 1stof the same year, 26 116 patients were on a waiting list, all organs combined. Unfortunately, 719 patients did not survive the wait. The vast majority of renal grafts are collected from brain-dead donors (2 784 grafts) and in recent years donor profiles have changed: donors are older with more cardiovascular antecedents. As such, transplantation is currently confronted with a twofold challenge: transplanting more patients from an insufficient number of donors and increasing the lifespan of transplant which are more fragile and sensitive due to ischemia lesions [Source: Agence de la Biomédecine / Greffe d’organes : données générales et méthodes https://rams.agence-biomedecine.fr/greffe-dorganes-donnees-generales-et-methodes-0].
Hemarina is a company founded in 2007 and headquartered in Morlaix (France). The company specializes in the development of universal therapeutic oxygen carriers derived from marine invertebrates. Hemarina has a technical & commercial affiliate in Boston (Hemarina, Inc.) and a production subsidiary for its raw materials located on the island of Noirmoutier.
Hemarina is developing several products for medical and industrial applications, including:
– An additive to organ preservation solutions: HEMO2life®
– A therapeutic oxygen carrier: HEMOXYCarrier®
– An oxygenating dressing: HEMHealing®
– An oxygenating gel for dental applications: HEMDental-Care®
– An additive to bone-filling materials: HEMDental-Regenerativ®
– An input for industrial bioproduction: HEMOXCell®/HEMBoost®
For more information, visit our website:www.hemarina.com
About Brest University Hospital (CHRU de Brest)
CHRU de Brest: Excellence, Humanity, Simplicity
CHRU de Brest is the leading healthcare player in Western Brittany with more than 8 000 agents spread over 9 sites. It offers a wide range of healthcare services in medicine, surgery, cancerology and many specialities such as psychiatry, geriatric, paediatrics and gynecology.
In 2019, more than 426 000 people came to CHRU de Brest for consultations, more than 95 000 people for emergency purpose and more than 25 8000 for surgery purpose.
Thanks to the promotion of partnerships with other institutions including work sharing, CHRU de Brest offers a wide range of healthcare services all over the territory.
As a university institute, CHRU de Brest develops a proactive policy in terms of training and research, with expert teams.
Media Relations Contact:
Acorelis – Gilles Petitot – firstname.lastname@example.org – Tél : 06 20 27 65 94
Hemarina – Nelly Rolland – email@example.com – Tél : 02 98 88 88 23
Scientifical contact : Dr Franck Zal – firstname.lastname@example.org