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Coronavirus. The Breton sea worm test suspended in emergency

The Medicines Agency urgently suspended this Thursday the test of a molecule from the blood of a sea worm, promoted by a Breton company. A 2011 study on pigs would have resulted in 100% lethality. The investigational product had not yet been administered to patients.

The clinical trial which planned to administer to patients with Covid-19 a solution derived from the blood of a sea worm was stopped Thursday, its authorization having been withdrawn pending a new evaluation, said the Public Assistance-Hospitals of Paris (AP-HP).

The Medicines Agency (ANSM) has decided to suspend urgently the green light that she had given for this study, after learning of the negative results of a previous study on pigs of this solution with very important oxygenation powers, manufactured by the Breton company Hemarina.

2011 study

Consequently, the AP-HP has decided to no longer be a promoter of this clinical trial, explains the hospital group in a brief press release, which specifies that the trial had not started and therefore no patient received this experimental product.

ANSM has just been informed of the completion in 2011 of a non-clinical study in pigs, which resulted in 100% lethality in animals having received this substance, observes the gendarme of the drugs in his decision, dated April 8 and transmitted by the AP-HP.

Now the results of this study were not transferred to the ANSM as part of the clinical trial authorization request, underlines the agency, adding that a revaluation […] is necessary to assess the risks involved with regard to the expected benefit for patients.

The AP-HP announced on Saturday the launch of this trial, which received authorization from the ANSM on March 27 and the green light from a personal protection committee on April 3.

Ten patients in very serious condition, hospitalized with an acute respiratory distress syndrome (ARDS) in the intensive care units of the European Hospital Georges-Pompidou and Pitié-Salpêtrière, should be administered this product to assess whether it was well tolerated and if it improved the oxygenation of their organs.

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