experimental drug Archives - Amazing Health Advances

NIH Researchers Identify Potential New Antiviral Drug for COVID-19

AHA Publisher — Tue, 08 Jun 2021 07:00:34 +0000

NIH/Eunice Kennedy Shriver National Institute of Child Health and Human Development via EurekAlert – The experimental drug TEMPOL may be a promising oral antiviral treatment for COVID-19, suggests a study of cell cultures by researchers at the National Institutes of Health. TEMPOL can limit SARS-CoV-2 infection by impairing the activity of a viral enzyme called RNA replicase. The work was led by researchers at NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The study appears in Science. “We urgently need additional effective, accessible treatments for COVID-19,” said Diana W. Bianchi, M.D., NICHD Director. “An oral drug that prevents SARS-CoV-2 from replicating would be an important tool for reducing the severity of the disease.” The study team was led by Tracey A. Rouault, M.D., head of the NICHD Section on Human Iron Metabolism. It discovered TEMPOL’s effectiveness by evaluating a more basic question on how the virus uses its RNA replicase, an enzyme that allows SARS-CoV-2 to replicate its genome and make copies of itself once inside a cell. Researchers tested whether the RNA replicase (specifically the enzyme’s nsp12 subunit) requires iron-sulfur clusters for structural support. Their findings indicate that the SARS-CoV-2 RNA replicase requires two iron-sulfur clusters to function optimally. Earlier studies had mistakenly identified these iron-sulfur cluster binding sites for zinc-binding sites, likely because iron-sulfur clusters degrade easily under standard experimental conditions. Identifying this characteristic of the RNA replicase also enables researchers to exploit a weakness in the virus. TEMPOL can degrade iron-sulfur clusters, and previous research from the Rouault Lab has shown the drug may be effective in other diseases that involve iron-sulfur clusters. In cell culture experiments with live SARS-CoV-2 virus, the study team found that the drug can inhibit viral replication. Based on previous animal studies of TEMPOL in other diseases, the study authors noted that the TEMPOL doses used in their antiviral experiments could likely be achieved in tissues that are primary targets for the virus, such as the salivary glands and the lungs. “Given TEMPOL’s safety profile and the dosage considered therapeutic in our study, we are hopeful,” said Dr. Rouault. “However, clinical studies are needed to determine if the drug is effective in patients, particularly early in the disease course when the virus begins to replicate.” The study team plans on conducting additional animal studies and will seek opportunities to evaluate TEMPOL in a clinical study of COVID-19. To read the original article click here.

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FDA Allows Emergency use of Antibody Drug President Trump Received

AHA Publisher — Mon, 23 Nov 2020 08:00:26 +0000

Associated Press via CBN News – U.S. health officials Saturday agreed to allow emergency use of a second antibody drug to help the immune system fight COVID-19, an experimental medicine that President Donald Trump was given when he was sickened last month. The Food and Drug Administration authorized use of the Regeneron Pharmaceuticals Inc. drug to try to prevent hospitalization and worsening disease from developing in patients with mild-to-moderate symptoms. The drug is given as a one-time treatment through an IV. The FDA allowed its use in adults and children 12 and over who weigh at least 88 pounds (40 kilograms) and who are at high risk of severe illness from COVID-19 because of age or certain other medical conditions. Emergency authorization allows use of the drug to start while studies are continuing to establish safety and effectiveness. Early results suggest the drug may reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression, the FDA said. Regeneron said that initial doses will be made available to roughly 300,000 patients through a federal government allocation program. Those patients will not be charged for the drug but may have to pay part of the cost of giving the IV. Initial supplies will likely be vastly outstripped by demand as the U.S. has surged past 12 million reported cases, with the country facing what health experts say will be a dark winter due to the uncontrolled spread of the virus. Antibodies are proteins the body makes to target and help eliminate viruses, but it can take weeks for the best ones to form after an infection occurs. The drugs are concentrated versions of ones that proved best able to do this in lab and animal tests, and in theory, help the body start to fight the virus right away. The Regeneron drug is a combo of two antibodies to enhance the chances it will prove effective. Earlier this month, the FDA gave emergency authorization to a single-antibody drug from Eli Lilly that also is still being studied. There’s no way to know whether the Regeneron drug helped Trump recover; he received a host of treatments and most COVID-19 patients recover on their own. FDA regulators authorized the Regeneron drug using their emergency powers to quickly speed the availability of experimental drugs and other medical products during public health crises. In normal times the FDA requires “substantial evidence” to show that a drug is safe and effective, usually through one or more large, rigorously controlled patient studies. But during public health emergencies, the agency can lower those standards and require only that an experimental treatment’s potential benefits outweigh its risks. The emergency authorization functions like a temporary approval for the duration of the COVID-19 pandemic. To win full approval, Regeneron will have to submit additional research to fully define the drug’s safety and benefit for patients. The White House cast the decision as a victory for Trump’s efforts “to deliver cutting-edge treatments with highly promising results to protect the health and safety of the most vulnerable Americans,” according to a statement from spokesman Michael Bars. To read the original article click here. For more articles from CBN News click here.

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5 Severe Covid Patients Cured by Experimental Drug

AHA Publisher — Fri, 02 Oct 2020 07:00:25 +0000

Abigail Klein Leichman via Israel21c – On October 1, the last of five Covid-19 intensive care patients who received the experimental drug Allocetra was discharged from Hadassah University Medical Center in Jerusalem. This was the successful outcome of the world’s first clinical trial of Allocetra, made by clinical-stage immunotherapy company Enlivex Therapeutics of Ness Ziona, Israel, from engineered human cells donated by healthy individuals. All five patients were discharged within about a week of receiving Allocetra and testing negative for the coronavirus. They reported no severe adverse events relating to the drug, and the therapy was well-tolerated. Allocetra was developed based on the research of Enlivex chief scientific and medical officer Dr. Dror Mevorach, head of internal medicine and of one of Hadassah’s coronavirus wards. On July 6, we included Enlivex as one of 13 promising Covid treatments emerging from Israel. This novel immunotherapy medication treats organ dysfunction and acute multiple organ failure associated with sepsis and Covid-19, as well as solid tumors, by rebalancing the immune system following a cytokine storm. “We have now treated 15 patients with Allocetra at our hospital, 10 with sepsis, and five with Covid-19,” said lead investigator Dr. Vernon van Heerden, chief of critical care at Hadassah. “Based on the compelling preliminary results that demonstrated safety and an indication of efficacy of Allocetra in these complicated patients, Enlivex’s product candidate has the potential to benefit Covid-19 patients in severe or critical condition.” Mevorach added: “We believe that the results of Allocetra treatment in these severe and critical Covid-19 patients represent a unique opportunity for Enlivex to contribute towards efforts aimed at combating the ongoing global Covid-19 pandemic.” Earlier this year, Hadassah treated 12 Covid-19 patients with an experimental immunoglobulin derived from the antibody-rich plasma of recovered patients. The serum, prepared by Rehovot-based biopharmaceutical company Kamada, led to improvement in 11 of the 12 patients within 24 to 48 hours, and all 11 were discharged a few days later. Kamada’s drug, however, is intended for moderately ill Covid-19 patients whereas Allocetra is for serious or critical cases. Enlivex believes that Allocetra, if approved, could potentially cover the gap that currently exists in treating severe or critical COVID-19 patients. A larger Phase II clinical trial is planned, subject to regulatory approval. To read the original article click here. For more articles from Israel21c click here.

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