Morlaix, Brittany (France), April 9th 2020 – Hemarina, the Breton biotech company, acknowledged the ANSM decision to suspend Monaco trial yesterday evening and the AP-HP (Paris Public Health Hospital Center) announcement confirming its decision not to be anymore the sponsor of the clinical trial. No patient was included in the trial.
Additional information was requested on April 8th by the National Health Authorities (ANSM). Hemarina provided the information related to a preclinical (animal model) study carried in 2011. Tests were made from a non-pharmaceutical product totally different from the current product. No conclusion could be made at that time with regard to a potential « benefit or no benefit of the product » on a particular lethal hemorrhagic shock model. Next M101 was evaluated on human for graft preservation purpose with conclusive results, after implementing a completely different protocol and formulation.
Hemarina regrets this « expeditious » decision from the AP-HP board not to continue this clinical trial, whereas the information requested by ANSM has been provided. « We remain confident in the potential of the Hemarina’s molecule being able to oxygenate patients reducing therefore the pressure on intensive care units » says Professor Laurent Lantieri, Head of Plastic Surgery in Georges Pompidou’s Hospital (Paris). He adds: « I was able to test by myself in my unit the safety and the performance of M101 in graft indication and notably in the case of a face transplantation ».
« We took notice of the AP-HP withdrawal, which we deplore » explains Franck Zal, founder of Hemarina. He concludes: « We are confident in having an authorization from the ANSM in a near future, on a collaboration with one or several clinical sponsors ».
M101 molecule
Hemarina developed a universal oxygen carrier molecule from lugworms. This molecule (M101) is a good candidate for treating respiratory distress syndrome responsible for death in cases of Covid-19.
Treating Covid-19 patients who have respiratory distress with this strongly oxygenating molecule would make it possible to directly and significantly alleviate intensive care units where life-support ventilators are scarce. Furthermore, this simple to implement therapy does not increase burden for clinical teams.
This technology has been validated by dozens of scientific publications. It has been successfully tested in grafts oxygenation as well as in brain oxygenation.
About Hemarina
Hemarina is a company founded in 2007 and headquartered in Morlaix, Finistère, France. The company specialises 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, as well as offices in Paris.
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
Media Relations Contact:
Acorelis Gilles Petitot – gilles.petitot@acorelis.com – Tel : 06 20 27 65 94
Hemarina Nelly Rolland – Tél : 02 98 88 88 23 Mail : nelly.rolland@hemarina.com
Medical and scientifical contact: Franck Zal – franck.zal@hemarina.com
