A drug that has shown promising results against coronavirus is going to be tested in four hospitals in Israel as part of a global trial involving some 40 clinical centers.
The drug, Selinexor, or XPOVIO as it is currently marketed in the US, was developed by oncology-focused pharmaceutical company Karyopharm Therapeutics. The company was co-founded by Israeli scientist Sharon Shacham in 2008. It is based in the US but maintains a regional office in Israel.
XPOVIO was developed for treating patients with relapsed or refractory multiple myeloma. It is FDA approved for this purpose. However, it has the potential to be a tool to fight the coronavirus, and clinical trials are needed to assess its effectiveness, according to Anat Haas Mizrahi, Karyopharm’s Israel general manager; and Dayana Michel, its senior medical director.
“In our research, we are committed also to develop drugs for additional purposes,” Haas Mizrahi told The Jerusalem Post. “One of the studies was focused on viral diseases, and we tested the drug for several of them. When the coronavirus emerged, we decided to look into our data and information, and we realized that there was an option that could be applicable for treating COVID-19, so we started looking into it.”
About a month ago, the company began to work around the clock on the treatment, realizing that the drug had the potential to disrupt the replication of the virus and to mediate anti-inflammatory effects, including respiratory infections. Tests were carried out on several animal models.
“With XPOVIO we can target COVID-19 both at the antiviral and at the anti-inflammatory levels, which would reduce the disease burden in all aspects important to the patient population,” Michel told the Post.
“In order to verify that our understanding was correct, we carried on two studies on animals whose infection resembles the modeling of human viral infection, and what we have seen is that in two different experiments the production of the virus was inhibited by 90% at a low dosage,” she said.
The clinical trial on patients has started across the US and Europe. It will involve 230 patients, selected by hospitals as suitable and who agree to be part of the test.
“We look for patients who are in serious conditions but not yet intubated, because we believe that this is the window where we can have an impact,” Michel said, adding that the treatment includes taking the drug orally three times a week for two weeks, a period that can be extended up to a month if needed.
Among the Israeli centers involved are Hadassah-University Medical Center in Jerusalem’s Ein Kerem, Sheba Medical Center in Tel Hashomer and Soroka-University Medical Center in Beersheba.
“It seems that the innovative mechanism of the drug developed by Karyopharm can affect the viral and inflammatory processes in the body,” said Prof. Nimrod Maimon, a specialist in internal medicine and pulmonology at Soroka.
“I hope it can help corona patients, and I’m eager to see the results of the experiment,” he said, according to a company press release. “Selinexor’s mechanism has proven effective for various diseases, and also in consideration of the high safety profile of the drug, the decision of testing it also in viral disease is right and important.”
Karyopharm expects the clinical trial to be completed in about three months.
It is too early to know what will happen next, Haas Mizrahi said.
“We will need to receive all the data from the trial first,” she said.
The testing was approved by the Health Ministry and the Central Ethical Committee in Israel.
Carrying out the trial in Israel was very important for Karyopharm, Haas Mizrahi said.
“We are very committed to the Israeli community,” she said.