An Israeli pharmaceutical company with a history of questionable claims regarding its potential HIV-turned-coronavirus treatment plans to apply for permission to conduct human trials in Israel and elsewhere, after saying that its drug has shown promise in stopping the virus from infecting cells in the lab.
Zion Medical’s Codivir, a peptide-based treatment, can purportedly stop the virus once a person is infected and prevent the onslaught of white blood cells that can lead to the rapid demise of previously mildly ill patients.
The drug is a rebranded version of its HIV therapy Gamorra, which it previously claimed had been proven effective against the coronavirus during a human trial in the Republic of the Congo, the only place where it has been approved for use. However, some questioned if the data backed the assertion.
Now the company has brought in Dr. Shlomo L. Maayan, head of the infectious disease division at Barzilai Medical Center in Ashkelon, as a consultant, who admitted that its earlier claims were overreach.
The rebranded drug was tested using in vitro insertion of SARS-CoV-2 into monkey cells at an independent assessment facility in London, where it showed promising signs, according to Maayan.
“The virus did not enter the cells,” he told The Times of Israel. “This was in contrast to the control group, where no peptide was added and the virus entered the cell and replicated rapidly.”
Dr. Einat Finkelshtain, the company’s chief scientist, said that the latest tests support her “biological hypothesis” that the drug can help fight the coronavirus.
Her team has just applied to Israel’s Health Ministry to conduct a clinical trial at Barzilai and Jerusalem’s Hadassah Medical Center. If approved, the trial will be conducted on mild to moderate COVID-19 patients.
“If this works on mild to moderate patients it could prevent deterioration to severe cases and prevent the cytokine storm,” Maayan said, referring to the immune overreaction that is believed to cause some of the most serious and deadly effects of the coronavirus.
The company announced that it also wants to begin emergency clinical trials with Codivir in several countries, including the US, within the next month.
The findings have not been peer-reviewed, and independent experts declined to comments on the claimed results.
Gamorra/Codivir was invented as an HIV drug, and was first produced two years ago. It hasn’t received approval anywhere apart from the Republic of the Congo, where it was okayed in the spring for treating HIV and cancer. But early in the pandemic, Zion Medical started looking into its possible use against the coronavirus.
The company received criticism from some doctors in May, after treating 15 COVID-19 patients in Congo with the drug and making sweeping claims about its effectiveness. Among other things, the company said it had run a clinical trial when it hadn’t.
Maayan acknowledged that the claims made in May were too far-reaching, but that the firm had cleaned up its act. “This time they have done a serious evaluation, in vitro studies in a reputable laboratory in London, where they checked the peptide activity against the coronavirus,” he said.
“It showed very good activity, sufficient to justify a clinical trial, and it was also shown that cellular toxicity was very low.”
In one experiment the peptide was added to liquid just before coronavirus cells were added, and in another, the cells and the virus were added at the same time. Maayan said that in both, the virus was stopped from entering cells, while in the control version of each experiment, conducted without the peptide, the virus entered the cells and replicated.
The company, based in Rehovot and registered as a business in Holland, was established in 2014 by Zyon Ayni, a Dutch-Israeli businessman with a real estate background, and is mostly focused on developing medical solutions for HIV/AIDS and cancer.