respiratory distress Archives - Amazing Health Advances

Drug Saves 47 of 50 Severe Covid Patients in Trial

AHA Publisher — Mon, 29 Nov 2021 08:23:27 +0000

Abigail Klein Leichman via Israel21c – Israel’s Bonus BioGroup reports a survival rate of 94 percent (47 of 50) of the severe Covid-19 patients treated with its drug product MesenCure in a Phase II, multicenter clinical trial. Study results, soon to be published, show MesenCure treatment reduced study participants’ hospitalization period by about half compared to a control group. All these patients had life-threatening pneumonia and respiratory distress caused by Covid-19. The data shows that MesenCure treatment reduced mortality by about 70% compared with the control group. Only two of the first 30 severe Covid-19 patients treated with MesenCure died due to Covid-19 or its complications, while 14 of 60 similar patients in the control group died. MesenCure treatment shortened the hospitalization period of severe Covid-19 patients by eight days on average, a reduction of 45% relative to the control group. The experimental group included women and men aged 41.4 to 77.4. About 77% of the severe Covid-19 patients treated in three hospitals with MesenCure had one or more risk factors for poor prognosis: hypertension, hyperlipidemia, obesity and Type 2 diabetes. Most were treated during the fourth Covid-19 wave in Israel, dominated by the Delta strain. The control group received the current standard of care — anti-inflammatory drugs in combination with steroids. This regimen, according to Bonus BioGroup, reduces mortality in hospitalized Covid-19 patients only slightly, from 25.8% to 21.8%, indicating that MesenCure is four times more effective. “We are proud of our success in leading the world to be a safer place by developing a medication for severe Covid-19 patients, thereby dramatically reducing the threat to their lives,” said Dr. Shai Meretzki, CEO of Bonus BioGroup. “In less than two years from the epidemic outbreak, we are the first in the world to report an effective and significant treatment for severely ill patients.” According to a statement from Bonus BioGroup, an independent expert committee confirmed the findings of the Phase II clinical trial of MesenCure and recommended continuing toward Phase III. Meretzki told the Jerusalem Post that the company will apply for emergency use approval from European and US regulatory agencies. To read the original article click here.

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Scientists Identify Drug They Hope Can Downgrade COVID-19 to Common Cold Level

AHA Publisher — Mon, 20 Jul 2020 07:00:04 +0000

Israel21c staff via Israel21c – Researchers show the coronavirus causes lungs to accumulate fat, so a cholesterol-lowering drug may help downgrade the virus threat to that of common cold. Could a well-known cholesterol-lowering drug help treat Covid-19? A research team led by Hebrew University of Jerusalem Prof. Yaakov Nahmias says that early research looks promising. Over the last three-months, Nahmias and Dr. Benjamin tenOever at New York’s Mount Sinai Medical Center have focused on the ways in which the SARS-CoV-2 (the coronavirus that’s causing our current pandemic) changes patients’ lungs in order to reproduce itself. Their major finding is that this virus prevents the routine burning of carbohydrates. As a result, large amounts of fat accumulate inside lung cells, and this enables the virus to reproduce. This new understanding of SARS CoV-2 may help explain why patients with high blood sugar and cholesterol levels are often at a particularly high risk to develop Covid-19. With this information in hand, Nahmias and tenOever began to screen FDA-approved medications that interfere with the virus’ ability to reproduce. In lab studies, the cholesterol-lowering drug Fenofibrate (Tricor) showed extremely promising results. By allowing lung cells to burn more fat, fenofibrate broke the virus’ grip on these cells. Within five days of treatment, the virus almost completely disappeared, the researchers report in this week’s Cell Press’ Sneak Peak. “With second-wave infections spiking in countries across the globe, these findings couldn’t come at a better time,” said Nahmias. “If our findings are borne out by clinical studies, this course of treatment could potentially downgrade Covid-19’s severity into nothing worse than a common cold.” To read the original article click here. For more articles from Israel21c click here.

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CBD May Help Reduce Cytokine Storm and Excessive Lung Inflammation in COVID-19

AHA Publisher — Sat, 18 Jul 2020 07:00:22 +0000

Medical College of Georgia at Augusta University via News-Medical Net – Cannabidiol, or CBD, may help reduce the cytokine storm and excessive lung inflammation that is killing many patients with COVID-19, researchers say. While more work, including clinical trials to determine optimal dosage and timing, is needed before CBD becomes part of the treatment for COVID-19, researchers at the Dental College of Georgia and Medical College of Georgia have early evidence it could help patients showing signs of respiratory distress avoid extreme interventions like mechanical ventilation as well as death from acute respiratory distress syndrome. ARDS is a major killer in severe cases of some respiratory viral infections “ARDS is a major killer in severe cases of some respiratory viral infections, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and we have an urgent need for better intervention and treatment strategies,” says Dr. Babak Baban, immunologist and interim associate dean for research at DCG and corresponding author of the study in the journal Cannabis and Cannabinoid Research. “Our laboratory studies indicate pure CBD can help the lungs recover from the overwhelming inflammation, or cytokine storm, caused by the COVID-19 virus, and restore healthier oxygen levels in the body.” (Dr. Jack Yu, co-author, physician-scientist and chief of pediatric plastic surgery at MCG) CBD findings Their CBD findings were enabled by their additional finding of a safe and relatively inexpensive model to duplicate the lung damage caused by ARDS. Work on the virus itself is limited to a handful of labs in the nation that can safely manage the highly contagious virus, and their newly reported approach opens more doors for studying SARS-CoV-2, COVID-19 and similar virus-induced conditions, they say. Their model, which takes advantage of the large, unique genetic structure of the novel coronavirus, produced classic symptoms of ARDS like the overwhelming, destructive immune response, then CBD significantly downregulated classic indicators of the excess, like inflammation-promoting cytokines as it improved oxygen levels in the blood and enabled the lungs to recover from the structural damage. Major problem with SARS-CoV-2 A major problem with SARS-CoV-2 is instead of just killing the virus, the over-the-top immune response can quickly disable the lungs, transforming them to a place where virus is replicated, rather than a place that makes oxygen available for our bodies and eliminates potentially harmful gases like carbon dioxide. Mechanical ventilators can take over these vital functions for a while, and enable critically ill people to use less energy to just breathe and have more energy to fight infection, while ideally the lungs recover from the assault. However evidence suggests 30-50% of patients who get to the point of mechanical ventilation, don’t survive. Interferon and Interleukin The cytokines in these now famous “storms” are a class of molecules like interferon and interleukin, secreted by immune cells and other cells like endothelial cells that line blood vessels, which impact cell communication and can both promote and deter inflammation. In the case of COVID-19, there is excessive production of inflammation-promoting molecules like the interleukins IL-6 and IL-1β, as well as immune cells like neutrophils and monocytes, the researchers say. They looked at objective measures of lung function in mice like levels of proinflammatory cytokines, oxygen levels in the blood before and after treatment, as well as temperature, an indicator of inflammation. Oxygen levels went up, while temperatures and cytokine levels went down with CBD therapy. Days later, a more detailed analysis of the lungs, reinforced reduction of key indicators of destructive inflammation, which their model, like the virus, drove way up including reduced levels of IL-6 and infiltrating neutrophils. In fact, both clinical symptoms and physical lung changes resulting from ARDS were reversed with CBD treatment, they say. Their model was created with the help of a synthetic analog of double-stranded RNA called POLY (I:C). In humans, our double-stranded DNA contains our genetic information and our single-stranded RNA carries out the instruction of our DNA to make certain proteins. In the family of coronaviruses, the double-stranded RNA carries the genetic material needed to reproduce the viruses and hijacks the cell machinery of our body to do that, Baban says. “The natural instinct of the virus is to make more of itself,” Baban says. “It weaves with our DNA to make the cell produce food and everything it needs.” Viruses also tend to have a tissue or tissues they prefer — some can and do go anywhere — and for SARS-CoV-2, the lungs are high on the list, he says. Double-stranded RNA Our bodies aren’t used to this double-stranded RNA so, like the virus, POLY (I:C) gets the immediate and extreme attention of toll-like receptor 3, a family of receptors that help our body recognize invaders like a virus and activate our frontline, innate immune response. “The toll-like receptors 3 see this and just go nuts,” Yu says. The fact that the coronaviruses are literally big and have the largest known viral RNA genome make such a vigorous cytokine and immune response both plausible and probable, adds Baban. Mice received three, once-a-day doses of POLY (I:C) in the nasal passageway. CBD was given by a shot in the abdomen, the first dose two hours after the second POLY (I:C) treatment, then every other day for a total of three days in a process that sought to mimic mice getting treatment about the time a human would begin to experience trouble breathing and likely seek medical care. Given too early, CBD might actually interfere with a proper immune response against the virus, Yu says. CBD quickly improved the clinical symptoms, then later detailed studies of the lungs showed damage to their structure, like tissue overgrowth, scarring and swelling, also had totally or partially resolved. Their next steps include doing similar studies on other organs impacted by COVID-19 including the gut, heart and brain, Baban says. At least one way CBD is thought to calm the immune response is because it looks similar to endocannabinoids, a natural cell signaling system in our bodies believed to be involved in a wide variety of functions from sleep to reproduction to inflammation and immune response. CB1 and CB2, the main receptors for this system, are found extensively throughout the body including the brain and respiratory system, where we breathe in manmade and natural irritants in the air — as well as viruses and bacteria — that might inflame. While understanding the workings of the natural endocannabinoid system is still very much a work in progress, it’s thought that one way CBD works to reduce seizures, for example, is indirectly through the large number of CB1 receptors in the brain, says Yu. CBD is available without a prescription, and is used to treat problems like seizures as well as Parkinson’s, Crohn’s and other conditions where pain and/or inflammation are a major factor. It’s derived from the hemp and cannabis plant, which are essentially the same although hemp has a much lower concentration of the “high” producing THC. Other investigators have shown the calming effect of CBD, for example, can block IL-6 in other models of inflammatory disease. ARDS is a rapid, severe infection of the lungs that results in widespread inflammation, shortness of breath, rapid breathing and the inability to sustain adequate oxygen levels to the body and brain. Shortness of breath or difficulty breathing are some of the early signs of COVID-19. ARDS is a major cause of death in patients who are critically ill for a variety of reasons, including common sepsis. To read the original article click here.

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13 Emerging and Promising Covid Treatments

AHA Publisher — Thu, 09 Jul 2020 07:00:09 +0000

Abigail Klein Leichman via Israel21c – “We believe humanity needs a toolbox of different solutions for Covid-19,” says Immanuel Lerner, CEO of Pepticom, one of the companies detailed below. In parallel to vaccine research, there’s an urgent need for effective treatments for the respiratory disease caused by the SARS-CoV-2 coronavirus. Scientists across the globe are working on vaccines to prevent Covid-19 infection. (Click here to read about six Israeli vaccine candidates.) But in the meanwhile, and even after initial vaccines are approved, there is an urgent need for effective treatments for the respiratory disease caused by the SARS-CoV-2 coronavirus. Most potential treatments target the life-threatening lung inflammation typical of serious Covid-19 cases. It’s caused by a phenomenon called a “cytokine storm.” Cytokines are proteins that trigger inflammation as a natural response to infection. In response to a virus overload, in this case in the lungs, the immune system activates a storm of cytokines. Too many cytokines lead to too much inflammation, which can damage the lungs and cause respiratory distress. Israeli hospitals were among the first anywhere to use dexamethasone, a steroid drug, to stop cytokines storms and reduce lung inflammation in severely ill Covid-19 patients. However, steroids can suppress the immune response too strongly. Additionally, an Israeli hospital is among the first to do a randomized, double-blind, placebo-controlled clinical trial of ivermectin, a drug to treat parasitic infections in people and animals, to see if it can shorten the duration of the disease if given to Covid-19 patients immediately after diagnosis. Israelis are also formulating novel therapeutics of their own. Below we summarize 13 potential Israeli treatments using a variety of approaches – such as placenta-derived cells, peptides, blood plasma of recovered patients, and the cannabis compound CBD. There is plenty of room for more than one treatment. “We believe humanity needs a toolbox of different solutions for Covid-19,” says Immanuel Lerner, CEO of Pepticom, one of the companies detailed below. Pluristem On June 11, Pluristem Therapeutics of Haifa announced a multicenter Phase 2 US Food and Drug Administration (FDA) efficacy and safety study of its PLX-PAD cells for treating severe Covid-19 complicated by acute respiratory distress syndrome (ARDS). PLX, an injected regenerative placenta-derived cell therapy, stimulates the immune system’s natural regulatory T cells and M2 macrophages, possibly preventing or reversing a cytokine storm. PLX cells potentially reduce the incidence and/or severity of Covid-19 pneumonia and pneumonitis. Pluristem has treated Covid-19 patients under compassionate use programs in the United States and Israel. Initial data from 18 patients showed that 75% were off mechanical ventilation within 28 days. “PLX cells are available off-the-shelf and once commercialized, can be manufactured in large-scale quantities, offering a key advantage in addressing a global pandemic,” the company said. Silkim Jerusalem-based Silkim Pharma recently submitted Coronzot, its novel treatment for Covid-19 patients with moderate to severe symptoms, to the FDA’s Investigational New Drug (IND) program. IND designation would give Silkim permission to start human clinical trials and to ship Coronzot across state lines before a marketing application has been approved. Coronzot’s novel mechanism targets a pivotal factor in cytokine storms. It removes an inflammatory overaccumulation of labile iron and replaces it with a minute amount of gallium or zinc. This not only suppresses the storm but also inhibits viral proteins that attack the lungs and heart. Gallium inhibits virus replication and promotes apoptosis (self-destruction) of already invaded cells. Zinc helps suppress inflammatory reactions and enzymes that enable coronavirus replication. The company is actively engaged in the FDA process. “We look forward to finalizing the IND and then moving towards conducting clinical studies of Coronzot for Covid-19,” said Silkim Pharma CEO Dror Chevion. RedHill Biopharma RedHill Biopharma, based in Raleigh, North Carolina and Tel Aviv, is “moving rapidly to advance our development program with opaganib for Covid-19,” according to a June 10 statement by Dr. Mark L. Levitt, RedHill medical director. RedHill acquired opaganib from US-based Apogee Biotechnology, which developed this oral drug to fight cancer, inflammation and viruses. RedHill has seen encouraging preliminary findings from six Israeli Covid-19 patients given opaganib under compassionate use to reduce lung inflammation. All were weaned from supplemental oxygen and discharged from the hospital without having to receive mechanical ventilation. RedHill plans a multi-center, randomized, double-blind, parallel-arm, placebo-controlled Phase 2/3 clinical study on 270 US patients with severe Covid-19 pneumonia. “We are expanding the development program to Russia and additional European countries, in parallel with the US clinical study, in order to accelerate the collection of robust data on the potential efficacy of opaganib against Covid-19,” said Levitt. The company is working with government agencies worldwide to allow more patients access to the investigational drug through clinical studies and compassionate use programs. InnoCan InnoCan Pharma Israel and Tel Aviv University tech-transfer company Ramot are collaborating to develop a new CBD-loaded exosome technology to fight lung inflammation. Exosomes, small particles created from stem cells, can act as “homing missiles” targeting specific damaged organs and facilitating cell-to-cell communication. Combining the cell-healing properties of exosomes with the anti-inflammatory properties of the cannabis-derived compound CBD is expected to have a strong synergetic effect. The treatment is administrated by inhalation. Stero Biotechs Stero Biotechs of Bnei Brak has started a small clinical trial at Rabin Medical Center in Petah Tikva on the tolerability, safety and efficacy of a CBD-enhanced steroid treatment for hospitalized Covid-19 patients. “Steroid treatment is usually the first or second line of treatment for hospitalized patients. CBD enhances the therapeutic effect of steroid treatment and treats the bio-mechanism affected by the virus,” the company explained. Eybna and CannaSoul Two Israeli cannabis R&D firms, Eybna Technologies and CannaSoul Analytics, are developing a proprietary terpene formulation for modulating cytokine storms. Terpenes are organic compounds found in cannabis and other plants. Studies suggest they can be effective antiviral agents. CannaSoul’s Cytokine Storm Assay (from its Myplant-Bio subsidiary) will aid in optimizing and customizing Eybna’s novel NT-VRL inhaled formulation for treatment and prevention of viral infections in high-risk populations and actively ill patients. “The FDA considers this assay as a good predictor for cytokine storm response and immunotoxicity, and it is commonly required in the development of biological treatments,” according to CannaSoul Chairman and CSO Prof. Dedi Meiri. “The NT-VRL formulation intended to be used via inhalation,” said Eybna CEO Nadav Eyal. “This delivery method dramatically increases the terpenes’ bioavailability by directly contacting the infected cells in the respiratory system.” CannaSoul aims to identify other cannabis molecules capable of suppressing a cytokine storm in response to Covid-19 without completely suppressing the immune system. It is also studying how cannabis molecules could modulate the ACE2 receptor, which allows the virus to inject its genetic expression into human cells. Kamada Based in Rehovot, Kamada has begun supplying its experimental plasma-derived Hyperimmune IgG therapy for compassionate use in severe Covid-19 cases in Israel. The treatment is based on plasma donated by recovered Israeli Covid-19 patients. One critically ill patient at Hadassah Medical Center showed initial improvement after having the experimental IgG therapy but ultimately did not survive. During the third quarter of this year, Kamada expects to start a Phase 1/2 clinical study in hospitalized Covid-19 patients in Israel and hold a pre-IND meeting with the FDA to expand clinical development in the United States in partnership with Kedrion Biopharma. Kedrion is collecting plasma from recovered American Covid-19 patients at 23 FDA-approved centers across the United States. This will be used by Kamada to manufacture additional batches of the product. “To the best of our knowledge, Kamada is the first company globally to complete manufacturing of a plasma-derived IgG product for the treatment of Covid-19,” said Kamada CEO Amir London. Israel Institute for Biological Research The government-run Israel Institute for Biological Research (IIBR) announced in May that analogues of two drugs for Gaucher’s disease proved effective against SARS-CoV-2. This drug cocktail is made up of the FDA-approved Cerdelga and an analogue of a second drug in advanced stages of the approval process. The IIBR study on cell cultures demonstrated that the two-drug treatment significantly reduced the replication capacity of the coronavirus and the destruction of the infected cell. This potential treatment is currently being tested in animals infected with the coronavirus. The IIRB also isolated several key coronavirus antibodies that successfully neutralized aggressive coronavirus in lab tests. These could form the basis of a future treatment following further testing. Pepticom Based in Jerusalem, Pepticom computationally designs novel peptide drug candidates using artificial intelligence. The company raised $5 million last year. Three months ago, Pepticom began implementing its proprietary AI technology on various coronavirus proteins to identify novel peptides that inhibit interaction between the spike protein of SARS-Cov-2 and the ACE2 receptor – thereby stopping the virus from entering the cell. CEO Immanuel Lerner says three such proteins have already been identified and are being validated in the lab. “Using AI is a fast way to find these peptides, which are less expensive and easier to produce than antibodies,” Lerner tells ISRAEL21c. “Many parties are interested in looking at our results and finding ways to develop this further.” Bonus BioGroup In April, Bonus BioGroup initiated a preclinical study of MesenCure, its unique drug for treating acute and life-threatening respiratory distress in coronavirus and pneumonia patients. MesenCure consists of activated mesenchymal stromal (stem) cells from healthy adult donors. The activation of these MSCs is intended to boost their ability to reduce lung inflammation, promote regeneration of the diseased lung tissue, and alleviate respiratory and other symptoms in the lungs. The development of MesenCure relies on more than a decade of related experience and technologies that Bonus BioGroup has used in developing its lead product, a tissue-engineered bone graft also based on MSCs. “With the current coronavirus outbreak, Bonus BioGroup has started tissue culture studies into the potential of these MSCs, further activated, to alleviate inflammation, including in the lungs, and possibly attenuate the cytokine storm in COVID-19 patients,” the company explained. The preclinical study in several animal models is expected to be completed in the third quarter of 2020. The company said preliminary results indicate that “following the treatment with MesenCure, the microscopic appearance of the treated lungs was similar to a healthy lung, and a significant improvement in additional related parameters was achieved.” Bonus BioGroup presented these results to 1,800 scientists, physicians, and public opinion leaders at the virtual conference of the International Society for Cell & Gene Therapy in May. NanoGhost Technion-Israel Institute of Technology Prof. Marcelle Machluf developed a drug-delivery technology that uses reconstructed mesenchymal stem cells as nano-vesicles to transport medicine directly to a target. NanoGhost is the startup she established to commercialize the technology, which has proven successful in treating pancreatic, lung, breast, prostate, and brain cancer in mice. The NanoGhost technology has been patented in the United States and Europe, with additional patents pending in India and China. Now, Machluf is adapting her technology to create decoy NanoGhosts that attract and entrap the coronavirus, making for a less severe infection. She explains it in the video below. Enlivex Enlivex Therapeutics of Ness Ziona is developing Allocetra, a novel immunotherapy medication to treat organ dysfunction and acute multiple organ failure associated with sepsis and Covid-19, as well as solid tumors. Allocetra rebalances a severely unbalanced immune system by engaging with the immune system’s own regulation mechanisms. It is designed to restore safe immune balance following a cytokine storm. Enlivex is starting to recruit Covid-19 patients in Israel and in the United States to test the potential effect of Allocetra on moderate to severe cases. A patent from the Japan Patent Office is expected during the third quarter of 2020. Weizmann Institute of Science Organic chemist Nir London of the Weizmann Institute of Science in Rehovot is co-leading a collaborative project to identify small molecules that can bind to and inhibit a protease enzyme that the SARS-CoV-2 virus needs to reproduce. London and his research team had previously developed an advanced method for identifying potential inhibitors for numerous proteins. “So far, we have made close to 800 compounds and...

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