Hadassah Hospital reported yesterday that five coronavirus treated in the hospital in an initial trial of a product of Enlivex Therapeutics Ltd. (Nasdaq: ENLV; TASE: ENLV) were released after their condition improved. The patients recovered within 5-8 days. At the time of their release, all five patients tested negative for the virus.
Enlivex's share price rose 21% on Nasdaq yesterday following Hadassah Hospital's announcement. In Tel Aviv today, the stock soared 120% after an official announcement by the company. The jump in Enlivex's share price sent the Tel Aviv Biomed Index up by 5%. In early trading on Nasdaq today, the share price is up 87% at $11.11, giving a market cap of $150 million.
Enlivex chairman Shai Novik said, "We are dealing with the difficult and critical patients, that is, the most challenging ones even among those hospitalized. It's hard to say how many of the five severely ill patients would have been expected to recover without the treatment, but we certainly would not have expected recovery for all of them."
Novik says that analysis of the trial is continuing, and that he company will publish further details 28 days after the treatment of the last patient ends, which is the official monitoring period for the trial.
Enlivex's product, Allocetra, was developed by Prof. Dror Mevorach, the company's chief scientific and medical officer. Who also runs the Covid-19 ward at the hospital. The product is designed control the activity of the body's immune system, which in severe cases of infectious disease is liable to run out of control and itself attack the body, causing worse damage than the virus itself, so that in the end the patient dies because of the activity of the immune system and not from the direct effect of the virus. This is a process known as cytokine storm.
Allocetra is due to enter Phase II (efficacy) trials for treating sepsis, but when it turned out that Covid-19 was causing cytokine storm in severely ill patients, Enlivex decided to apply its product to this problem. "Even if the coronavirus returns in a different form," says Novik, "and even if a new pandemic comes along tomorrow from some other wild animal that someone decides to eat, and even if vaccines for coronavirus are not 100% effective, we will be relevant.
"The fact that the tests on the five patients came back negative strengthens our assessment that an immune system that does not run amok can better deal with the virus itself."
Novik says that Enlivex intends to talk with officials at the US Food and Drug Administration, and also with the Ministry of Health in Israel, on the possibility of an emergency use authorization for the product, on the basis of the results of the current trial, even before a controlled trial is held. At present, Enlivex's treatment is allowed for compassionate use, that is, for patients in a critical condition for whom no other possibility of treatment remains.
Two questions about Enlivex's encouraging announcement
Guy Ben Simon
Enlivex's clinical trial covered five Covid-19 patients, three in severe condition and two in critical condition. The company reports that "All five patients had complete recovery from their respective severe/critical condition and were released from the hospital after an average of 5.5 days (severe) and 8.5 days (critical), following administration of Allocetra, at which time they were all Covid-19 PCR negative. There were no reported severe adverse events relating to the administration of Allocetra in the patients, and the therapy was well-tolerated."
Despite the optimism, it should be pointed out that the announcement lacks several material facts, such as the ages of the patients, their sex, and whether they suffered from background medical conditions, data usually provided in the case of such trials. But that is not all.
It is difficult, even impossible, to conclude that a trial is a success on the basis of just five patients. They do not represent an adequate sample, certainly in respect of safety, which is usually checked among tens of thousands of patients. But it seems that the thirst for an antidote to the coronavirus led investors to make allowances for the company.
Enquiries by "Globes" found that Hadassah Hospital, where the trial took place, came out with its optimistic report early, forcing the company to make an imperfect announcement, to say the least.
There is a further point concerning Hadassah Hospital. Enlivex's product was developed by Prof. Dror Mevorach, who also heads the hospital's coronavirus department. A clinical trial is usually spread over several hospitals, but this was exclusively at Hadassah, which controls listed company Hadasit Bio-Holdings Ltd., which is in turn the main shareholder in Enlivex, raising questions about a possible conflict of interests.
With Enlivex's share price currently up by 83% on exceptionally high turnover, the share price of Hadasit Bio-Holdings is up by 110%.
Published by Globes, Israel business news - en.globes.co.il - on October 1, 2020
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