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with Covid-19 a solution derived from the blood of a sea worm was stopped Thursday, its authorization having been withdrawn pending a new evaluation, said the Public Assistance-Hospitals of Paris (AP-HP).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.
– .