The world’s first clinical trial for a drug made of antibodies coronavirus began a promising start in Jerusalem, with all three patients involved released from the hospital days after receiving it.
The patients were in moderate condition, with COVID-19-induced pneumonia, when the drug was given, produced from antibodies found in the plasma of recovered coronavirus patients, earlier this week.
“The reaction was, in my eyes, it was almost a miracle – they got it and they are home now,” said Zeev Rothstein, director of Hadassah Medical Center in Jerusalem, who worked with the biopharmaceutical company Kamada to dispense the medicine. developing, and is now running the clinical trial.
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The trial began last Thursday, and includes the treatment of 12 patients, in batches. The first batch consisted of three patients, of whom was discharged last Wednesday. Doctors say the patients are well enough to rest at home, but have not yet tested negative for COVID-19.
Rothstein commented: ‘I do not know if it is beginner happiness, but we are very enthusiastic. For a doctor to see such an improvement in such a short period of time is amazing. ”
Zeev Rothstein, Director of Hadassah Medical Center (courtesy of Hadassah Medical Center)
He said he was “trying to be careful” because he was disappointed by some treatments that are tout for the coronavirus, but added: “If tears show the efficiency we expect, it will not only worsen the situation. of patients, but could change attitudes towards coronavirus in Israel and around the world. ”
Rothstein expressed the hope that other Israeli hospitals will participate in this phase of testing, both for the benefit of patients who can benefit and to strengthen the reliability of results.
Kamada was the first company in the world to produce a coronavirus medication from antibodies and has now become the first company to clinically test such a product, said its CEO, Amir London. He added that the medicine, which is currently being tested on active patients, will also be investigated for possible preventive qualities.
In May, The Times of Israel first reported on plans for such treatment based on Israeli blood samples.
London has not yet commented on the clinical trial, as it is awaiting data from all 12 patients who will need to receive treatment in this initial phase of testing.
A recovering coronavirus patient (center) donating plasma for the treatment of experimental antibodies in Israel. (Magen David Adom)
Israeli patients have received antibodies from recovering patients since early in the pandemic, but this medicine, although based on antibodies, is “very different,” London said.
He commented: “We use conquering plasma as our raw material, but then it comes to pharmaceutical development and processing to become a medicine. If you give an infusion [of regular antibodies] you do not know exactly what you are giving. “
With the new product, he said, the manufacturing process ensures that the amounts of antibodies are predefined and standardized and patients are provided with an “anti-viral treatment that can reduce viral load.”
Amir London, CEO of the biopharmaceutical company Kamada. (courtesy, Kamada)
It is tested on moderate patients because they are believed to have more consistently high viral loads than serious patients, who sometimes struggle with the aftermath of the virus instead of the virus itself.
“We give it to moderate patients, with pneumonia but not yet ventilated,” London said. “We want to catch them while they are still very vital, but before they get worse, and treat this viral phase with an anti-viral treatment.”
The product is hyperimmune globulin, sometimes referred to as a passive vaccine. It is called passive because, unlike a regular vaccine, which requires the body to make antibodies to fight viruses or bacteria, it contains preformed antibodies.
Hadassah, along with Magen David Adom, who runs Israel’s blood service, began collecting plasma from recovering patients three months ago for the development of the drug. Hadassah’s statement said it did so, “despite initial opposition from the then director general of the Ministry of Public Health,” referring to Moses Bar Siman-Tov, who resigned in May.
The ultra-Orthodox community of Jerusalem was the key to facilitating plasma collection needed for the drug. When she realized that large quantities of plasma antibody plasma were needed in a short time, Hadassah turned to Haredi leaders through the Yad Avraham nonprofit. Rothstein said, “We went straight to the Haredi community, where coronavirus was widespread, and the idea of helping people to each other brought a good response.” Some 126 volunteers came forward.
Kamada, which has received an approval from the US Food and Drug Administration for an antibody treatment for rabies, changed its product to treat the coronavirus.
