[The Jerusalem Post] Israeli firm ready to assist coronavirus victims with novel drug
A clinical-stage Israeli immunotherapy company, specializing in drug development for sepsis and organ dysfunction, is "ready to assist" health authorities combating deadly complications caused by the novel coronavirus.
Based in Nes Ziona, Enlivex's "Allocetra" cell-based therapy seeks to treat life-threatening conditions characterized by immune system overreaction - primarily sepsis - through a process of immune system rebalancing. Nearly 270,000 Americans die annually as a result of sepsis, or one-third of all patients who die in US hospitals.
According to Shai Novik, the executive chairman of Enlivex, the company's therapy could also potentially assist many severe cases of coronavirus, in which the disease causes a potentially fatal overreaction of the immune system, leading to organ dysfunction and subsequent failure.
Among the first 99 individuals diagnosed with severe cases of coronavirus, 11 died from multiple organ failure, according to a study published in scientific journal The Lancet. There are currently no FDA-approved pharmacologic treatments for such cases.
"Scientific publications in the last 10 years have shown that one identifiable characteristic of hard cases of similar viral infections such as SARS, MERS, Avian Flu and Corona viruses is a cytokine storm," Novik told The Jerusalem Post, citing a severe immune reaction that results in massive release of immune system enhancement signals into the blood. "Essentially, the literature teaches us that it is not necessarily the virus that is killing the patient, but it is the overreaction of the immune system."
While the coronavirus, named 2019-nCoV, can cause mild flu-like symptoms in many cases, more serious cases can lead to sepsis, severe pneumonia, septic shock and acute respiratory distress syndrome. The young, elderly and those with existing chronic conditions are expected to be at greater risk of developing severe symptoms.
"We are targeting sepsis, which is a larger problem than these viral infections and kills way more people every year around the world, with a mortality rate of about 30-40%," said Novik. "We do believe that we could potentially assist various ministries of health around the world that have a desire to try and help patients whose manifestations of the disease started to result in organ dysfunction and organ failure."
Novik emphasizes that Enlivex's therapy, which delivered positive results in the first 6 sepsis patients with multiple dysfunctional organs in a 2019 Phase 1b clinical trial, cannot vaccinate against or kill the coronavirus, but it could offer hope to patients suffering from multiple organ failure due to the virus by returning overreactive immune systems from a state of cytokine storm to equilibrium. A full dataset of 10 patients is expected to be released within the next 30 days.
The innovative therapy is based on the research of Prof. Dror Mevorach, a senior physician from Hadassah-Hebrew University Hospital who founded Enlivex and serves as the company's chief scientific & medical officer. Prior to joining the company, Novik founded therapeutic protein developer PROLOR and sold the company in 2013 to OPKO Health for $480 million.
The six patients who enrolled in the Phase 1b clinical trial of Allocetra, all suffering from severe sepsis, tolerated the infusion without serious adverse events and "demonstrated swift clinical improvement after administration of the standard of care treatment" combined with the drug. All the patients were released from the hospital after severe sepsis had been eliminated.
Novik says the company is currently reaching out to authorities involved in the global attempt to find an immediate solution, and offer their solution on an experimental basis. Looking forward, he suggests Enlivex's generic therapy could be stockpiled by governments "to combat hard cases of any potential future outbreak" of similar viruses.
"We are thinking strategically about what we can do to create inventories in places around the world, so the therapy can be used relatively swiftly for the first few thousand patients that are infected," said Novik. "Some patients may have organ dysfunction or failure and we can really help to try to prevent it."
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