Equipo Nizkor - Israeli COVID-19 Drug That Targets Fatal ‘Cytokine Storms’ Approaches Pivotal Late-Stage Trial.

Five doses from a small bottle given to patients with moderate to severe COVID-19 before they need ventilation could revolutionize their chances of recovering from the life-threatening disease, according to results in May from a set of Phase 1 trials in Israel.

The experimental treatment — dubbed EXO-CD24 and developed by Tel Aviv’s Ichilov Medical Center — is given once a day by inhalation for only a few minutes, over the course of five days, and has successfully prevented clinical deterioration of 30 moderate to severe COVID-19 patients in the trial.

The inhaler drug is currently being tested in a second round of clinical tests in Greece, where up to 90 COVID-19 patients are expected to be enrolled, according to Professor Nadir Arber, who leads the drug’s development Ichilov. On the assumption that upcoming clinical trials will demonstrate that the experimental drug is safe and effective, Arber told The Algemeiner he expects to file applications for emergency use authorization of EXO-CD24 with the US Food and Drug Administration (FDA) and other regulatory bodies by the end of this year or the beginning of 2022.

“We can definitely declare that the drug is safe and has no side effects,” Arber said. “We are very optimistic about the recovery of the patients in Greece where we are testing different doses of the drug. We expect the trial to be completed by the end of July.”

The trial is conducted at a leading hospital in Greece followed discussions in February between former Prime Minister Benjamin Netanyahu and his Greek counterpart Kyriakos Mitsotakis, who expressed great interest in bilateral cooperation in the clinical trials.

“If this succeeds, it will be huge, simply huge. This is of global significance. This is amazing. This little thing could change the fate of humanity. Good luck,” Netanyahu told Arber in a February meeting.

EXO-CD24 is a targeted experimental drug, developed to fight the second phase of COVID-19 on the basis of many years of research in the laboratory run by Arber, who specializes in preventing cancer.

The first phase is the flu-like viral infection which requires no special therapy, only supportive care. But phase two of the virus outbreak, presenting after five to seven days, can see a rapid deterioration caused by an overreaction of the immune system, mainly in the lungs. It occurs in 5-7% of patients, often in those with pre-existing risk factors, and is known as a cytokine storm. EXO-CD24 inhibits that immune overreaction, thought to be responsible for many of the deaths claimed by the virus — and according to Arber, which no drug has yet been proven to stop.

“The suffering is terrible. I don’t even know how to define it. Because I saw death coming in front of my eyes,” said Orli, a 54-year-old mother who recovered from COVID-19. “This medicine saved me. In three days, I just passed through it.”

EXO-CD24 is based on “exosomes,” explained Dr. Shiran Shapira, director of Arber’s lab.

These are “vesicles that are released from the cell membrane and used by the body for intercellular communication,” Shapira said. “We enrich the exosomes with a protein called CD24. This protein is expressed on the surface of the cell and is known as an important regulator of the immune system.”

The treatment’s approach is unique, he said, in that it is directed straight to the target organs — namely, the lungs — unlike many existing treatments, which either try to inhibit a specific cytokine, or are aimed too broadly and thus threaten to cause severe side effects.

“In contrast, EXO-CD24 is given locally, has high efficacy, and does not cause any side effects,” Arber said.

Out of the 30 patients with severe COVID-19 who were treated with the experimental drug in a Phase 1 clinical trial in Israel, 29 patients saw “strong” improvement within two to three days — with most of them being discharged home within five days. The thirtieth patient also recovered, but after a longer hospitalization.

“For efficacy we need to conduct the Phase 2/3 trials and compare it to placebo. We already have the Israeli regulatory approval and expect to start the enrollment of about 152 patients at the beginning of August,” Prof. Arber said.

To complete the larger-scale trials, Arber and his team can’t rely on Israeli participants, since the country has very few hospitalized coronavirus patients following a successful vaccination drive. Meanwhile, the inhaled drug has already attracted interest abroad, especially from places with spiraling COVID-19 cases where widespread vaccine protection isn’t expected anytime soon, including India and inner Mongolia.

“A third wave will likely come in India. We are working with the Apollo hospital in India on how to best collaborate on R&D development and how it can help COVID-19 patients,” Arber said. “In the future, India could be strategic partner for us for the industrial production, marketing and selling of the drug with its many large pharmaceutical companies and factories.”

Arber claimed that with regulatory approval, the drug could be produced rapidly and at low cost, supplying worldwide need within a matter of months.

“Even with the highly effective vaccines available today, and even if no new mutations would appear, in one way or another, COVID-19 is here to stay,” he said. “That is why we have developed this unique approach, which we believe can potentially also serve as a platform for other indications such as sepsis, of which millions of people around the world die of every year.”

27Jun21

Israeli COVID-19 Drug That Targets Fatal ‘Cytokine Storms’ Approaches Pivotal Late-Stage Trial

[Fuente: By Sharon Wrobel, The Algemeiner, NY, 27Jun21]

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