“Health Canada Allows COVID-19 Patients with Respiratory Failure to Be Given NuvOx Pharma's Oxygen Therapeutic in Phase IIa Clinical Trial - Business Wire” plus 3 more

Health Canada Allows COVID-19 Patients with Respiratory Failure to Be Given NuvOx Pharma's Oxygen Therapeutic in Phase IIa Clinical Trial - Business Wire
Oral hygiene and severity of COVID-19 – the connection - News-Medical.Net
Active Anticancer Treatment Associated With Poor COVID-19 Prognosis - Cancer Therapy Advisor
Hofseth Biocare ASA: HBC starts its accelerated COVID-19 Phase 2 clinical trial of OmeGo® salmon oil to decrease Acute Respiratory Distress Syndrome and the need for assisted respiration - GlobeNewswire

Health Canada Allows COVID-19 Patients with Respiratory Failure to Be Given NuvOx Pharma's Oxygen Therapeutic in Phase IIa Clinical Trial - Business Wire

Posted: 29 Jun 2020 06:28 PM PDT

TUCSON, Ariz.--(BUSINESS WIRE)--NuvOx Pharma, a Tucson-based biotechnology company developing NanO₂™ emulsion for oxygen delivery, has received a "No Objection Letter" from Health Canada to proceed with a Phase IIa clinical trial of NanO₂ in COVID-19 subjects with acute hypoxic respiratory failure (AHRF). Some patients with AHRF can progress to a more severe form of the disease called acute respiratory distress syndrome (ARDS). ARDS, which is associated with lung inflammation leading to low blood oxygenation, is the major cause of death in COVID-19 patients. Evan Unger, MD, President and CEO of NuvOx Pharma, said, "We had data in several animal models showing that NanO₂ restored oxygen levels in conditions of low oxygen caused by ARDS or acute lung injury. We already have data in humans from when NanO₂ was tested in subjects with brain cancer and stroke showing safety and evidence of efficacy in both indications. Because of this, we designed a clinical trial to study NanO₂ in COVID-19 patients."

Diego Martin, MD, PhD, Chairman of Radiology at McGill University, Montreal, Canada, Principal Investigator of the Canadian efforts on the trial, said, "We are excited to collaborate with NuvOx Pharma on this project. I have been collaborating with Dr. Unger to study models of myocardial infarction where we have published evidence that shows NanO₂ can act as a cardioprotectant. In addition to ARDS, COVID-19 patients suffer multi-organ damage to the heart, brain, kidneys and other organs. In fact, a large percentage of patients who succumb to COVID-19 also have underlying cardiac disease or cardiovascular risk factors. NanO₂ appears to be reversing ischemia-mediated pathways of inflammation and tissue injury in lung, heart and other tissues, which may make it particularly well-suited as a treatment in COVID-19 subjects."

Jarrod Mosier, MD, Associate Professor with Tenure Emergency & Internal Medicine and Associate Program Director of the Critical Care Fellowship at Banner University Medical Center, Tucson, AZ, is a Principal Investigator of the US sites in the clinical trial. Dr. Mosier said, "NanO₂ will be administered as a sustained IV infusion in the clinical trial. The first phase of the trial is a dose escalation design to determine the best dose, after which additional subjects will be enrolled at that dose as a dose expansion phase. The trial will determine if NanO₂ improves clinical outcomes in COVID-19 subjects with acute hypoxic respiratory failure. NanO₂ has the potential to transform the care of COVID-19 patients who present with low oxygen saturation."

Disclaimer: Certain statements in this release may constitute "forward-looking statements." Actual events or results may differ substantially as a result of risks and uncertainties facing us. The forward-looking statements are based on current expectations as of the date of these statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of future events, new information, or otherwise.

Oral hygiene and severity of COVID-19 – the connection - News-Medical.Net

Posted: 30 Jun 2020 07:46 PM PDT

British researchers have found a link between poor oral hygiene and severity of COVID-19 disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. The study from researchers Victoria Sampson, from the dental practice 38 Devonshire Street, London, Nawar Kamona from the Centre for Nutrition Education & Lifestyle Management (CNELM), London and Ariane Sampson from Orthodontics, Cambridge University Hhospital Trust, United Kingdom collaborated to find the connection between the severity of the infection and poor oral hygiene. Their study titled, "Could there be a link between oral hygiene and the severity of SARS-CoV-2 infections?" was published in the latest issue of the journal British Dental Journal.

SARS-CoV-2 viruses binding to ACE-2 receptors on a human cell, the initial stage of COVID-19 infection. Illustration credit: Kateryna Kon / Shutterstock

The COVID-19 pandemic

Since December last year, there have been steadily increasing numbers of SARS-CoV-2 or novel coronavirus infection that causes COVID-19 diesase. The World Health Organization (WHO) declared COVID-19 a global emergency on the 30^th of January 2020 and, on the 11^th of March 2020, declared it a pandemic when this highly contagious virus infected populations across the world. As of today, globally, 10,434,385 people have been infected and there have been 509,779 deaths attributed to the virus around the world due to this infection.

What was this study about?

Researchers to date have identified several risk factors that are associated with severe COVID-19 course of disease and outcome. While many patients infected with the virus recover without complications, some may need hospitalization, oxygen supplementation, and even ventilation. Some of the risk factors associated with poor outcome of the disease include high blood pressure, diabetes obesity, and heart disease. The team of researchers explains that 52 percent of the deaths due to COVID-19 also occur in healthy individuals, and the cause behind this is unclear. They wrote that the main complications of COVID-19 include "blood clots, pneumonia, sepsis, septic shock, and ARDS (Acute respiratory distress syndrome)." These complications are seen mainly among those with comorbidities and bacterial overload, they wrote.

Bacteria and COVID-19 outcome

The team speculates that there may be a connection between SARS- CoV-2 infection and "bacterial load." They tried to explore if high levels of bacteria or bacterial superinfections and complications of bacterial infections such as pneumonia, sepsis, and respiratory distress syndrome could be associated with poor outcome from COVID-19.

Oral hygiene and COVID-19

This study explored the complications of COVID-19 seen among those with poor oral health and periodontal disease. The oral microbiome or the microbial flora of the mouth was explored and its connection with the COVID-19 outcome was analyzed. The authors wrote, "We explore the connection between high bacterial load in the mouth and post-viral complications, and how improving oral health may reduce the risk of complications from COVID-19."

The authors of the study wrote that during lung infection, there is a risk of aspirating the oral secretions into the lungs, which could cause infection. Some of the bacteria present in the mouth that could cause such infections include "Porphyromonas gingivalis, Fusobacterium nucleatum, Prevotella intermedia," they wrote. They explained that periodontitis or infection of the gums is one of the most prevalent causes of harmful bacteria in the mouth. These bacteria lead to the formation of cytokines such as Interleukin 1 (IL1) and Tumor necrosis factor (TNF), which can be detected in the saliva and can reach the lungs leading to infection within them. Thus, the researchers wrote, "inadequate oral hygiene can increase the risk of inter-bacterial exchanges between the lungs and the mouth, increasing the risk of respiratory infections and potentially post-viral bacterial complications."

Results of the study

The team wrote, "Good oral hygiene has been recognized as a means to prevent airway infections in patients, especially in those over the age of 70". Those with periodontal disease are at a 25 percent raised risk of heart disease, thrice the risk of getting diabetes, and 20 percent raised risk of getting high blood pressure, the researchers wrote. These are all risk factors of severe COVID-19 they wrote.

Conclusions and implications

This study concludes that 20 percent of the patients with COVID-19 progress to severe illness with high levels of "inflammatory markers (IL-2, IL-6, IL-10), bacteria, and neutrophil-to-lymphocyte count". They noted that the oral microbial environment and COVID-19 could be linked. The four essential risk factors for severe COVID-19, diabetes, high blood pressure, heart disease, and obesity, are also associated with poor oral hygiene, they wrote. They recommend "oral hygiene be maintained, if not improved, during a SARS-CoV-2 infection in order to reduce the bacterial load in the mouth and the potential risk of bacterial superinfection." These precautions are particularly important for those with diabetes, heart disease hypertension, they wrote.

Journal reference:

Active Anticancer Treatment Associated With Poor COVID-19 Prognosis - Cancer Therapy Advisor

Posted: 30 Jun 2020 08:00 AM PDT

Patients with cancer are more susceptible to infection with SARS-CoV-2, and patients receiving active anticancer treatment have a poorer prognosis compared with other patients in follow-up, according to results of an observational study published in Cancer.

Although overall the data have been mixed, this team of researchers from Wuhan previously reported that patients with cancer were at an increased risk of contracting COVID-19 compared with the general population in Wuhan. The aim of this study was to further characterize the outcomes of patients with cancer and COVID-19 in a larger cohort.

The multicenter observational study included 107 patients with cancer who were diagnosed with COVID-19 between January 2020 and March 2020. The median patient age was 66 years, 56.1% of patients were male, and 67.3% had comorbidities such as hypertension, diabetes, cardiovascular disease, and chronic obstructive pulmonary disease.

The most common cancers in the cohort were of the lung (19.6%), gastrointestinal tract (18.7%), genitourinary tract (18.7%), and head and neck (15.9%). Most patients had early-stage disease (78.5%), and 21.5% had stage IV disease. Additionally, 34.6% of patients were receiving active anticancer therapy at the time of their COVID-19 diagnosis and 10.3% were receiving best supportive care.

Overall, 52.3% of patients developed severe COVID-19, which was defined as tachypnea 30 respiratory rate/min or higher, oxygen saturation of 93% or less, arterial partial pressure of oxygen per fraction of inspired oxygen of 300 mm Hg or less, mechanical ventilation, septic shock, or multiorgan failure requiring intensive care unit admission. Oxygen support was administered to 85% of patients, with 16.8% requiring mechanical ventilation. Acute respiratory distress syndrome (ARDS) occurred in 19.6% of patients, heart failure in 12.1%, and acute renal injury in 2.8%.

For their COVID-19, 92.5% of patients received an antiviral, including oseltamivir, umifenovir, interferon-α, ribavirin, lopinavir, or chloroquine phosphate. Steroid therapy was administered to 36.4%, and 20.6% of patients received immunoglobulin. Steroid therapy and immunoglobulin were used less frequently in patients in the group who were receiving active treatment compared with those in the group who were in active follow-up.

Overall, patients undergoing active anticancer treatment had a poorer prognosis than patients in follow-up (hazard ratio, 3.365; 95% CI, 1.455-7.782; P =.005), which remained similar when patients receiving best supportive care were excluded.

Patients receiving active anticancer treatment were also more likely to experience severe COVID-19 than those who were not (64.9% vs 45.7%, respectively), require mechanical ventilation (29.7% vs 10.0%, respectively), and death (37.8% vs 12.9%, respectively). More severe lymphopenia and anemia, and greater elevation in C-reactive protein and procalcitonin, was also observed among patients undergoing active treatment.

The authors concluded that "based on this and other studies, it is therefore imperative to consider the deferment of anticancer treatment, if possible, in patients with cancer who unfortunately are diagnosed with COVID-19."

Reference

Zhang H, Wang L, Chen Y, et al. Outcomes of novel coronavirus disease 2019 (COVID-19) infection in 107 patients with cancer from Wuhan, China [published online June 23, 2020]. Cancer. doi: 10.1002/cncr.33042

Topics:

COVID19 General Oncology

Hofseth Biocare ASA: HBC starts its accelerated COVID-19 Phase 2 clinical trial of OmeGo® salmon oil to decrease Acute Respiratory Distress Syndrome and the need for assisted respiration - GlobeNewswire

Posted: 29 Jun 2020 11:17 PM PDT

Reference is made to the stock exchange notice on 26 May 2020 and Hofseth BioCare ASA ("HBC") announces that Health Canada has approved its accelerated phase 2 investigational trial protocol of CARDIO soft gel treatment for patients with Acute Respiratory Distress Syndrome (ARDS) caused by the SARS-CoV-2 virus. The trial will immediately begin recruiting patients from Greater Toronto based hospitals including Mount Sinai Hospital, Toronto.The trial will recruit 100 former smokers and steroid-resistant asthma patients ("Patients"), who exhibit early non-acute lung injury caused by the SARS-CoV-2 virus. As noted previously, publications from the US CDC, Chinese CDC and Italian CCM show former smokers to be at particularly high risk for COVID-19-based ARDS progression into ICU care. HBC's randomized, placebo-controlled trial will aim to slow the progression of ARDS in Patients with confirmed SARS-CoV-2 infection who exhibit early pulmonary symptoms. The Patients will receive the best current antiviral standard of care (BSC) in the placebo arm and BSC+CARDIO soft gels in the treatment arm. The primary endpoint will measure reduction in requirement for assisted respiration.An interim analysis will be performed after the first 30 Patients complete treatment. With a planned treatment duration of 15 days, an initial data read-out from the first part of the trial is anticipated within 12 weeks of the first patient goes on treatment. The trial is being initially funded from HBC's existing R&D budget for 2020.HBC's ongoing research has shown that the OmeGo® salmon oil present in the CARDIO soft gels contain lipid-soluble components that reduce eosinophil effector function (EEF) and increase eosinophil apoptosis (programmed cell death). These results have been validated in various invitro cellular assays at 100 ug/ml concentrations as well as animal model work at differing doses (g/kg) of OmeGo® oil. HBC believes that modulating eosinophil function, along with the other anti-inflammatory and antioxidant properties of OmeGo®, will reduce the number of Patients who will require assisted respiration management as well as reduce the total number of days on assisted respiration/ICU care.Eosinophils are white blood cells (leukocytes) which form part of the body's immune system helping to deal with infections. Changes in smoking patterns can trigger lung tissue injury via the recruitment and persistence of eosinophils. In former smokers, bilateral ground-glass opacities on CT-scan images are visible which appear to be similar to the CT lung images of COVID-19 patients. Mistimed and uncontrolled eosinophil production in lung epithelial cells plays a critical role in destruction of the respiratory epithelium and rapid development of acute ARDS.HBC recently announced the filing of a US patent application (630063274 04/07/2020) on minor components in OmeGo® salmon oil that significantly attenuate respiratory eosinophilic inflammation, as a treatment for the management of asthma, particularly steroid-resistant asthma.Overactivity of eosinophils is seen in numerous inflammatory conditions including eosinophilic asthma. About 7-8% of the population suffer from asthma. Eosinophils are estimated to be important drivers of asthma in around 40% of asthmatics overall and in up to 60% of patients with severe asthma. Inhaled bronchodilators ("relievers"), which expand the airways in the lungs, and inhaled corticosteroids, which reduce airway inflammation, are a mainstay of asthma treatment. However, a significant number of patients still suffer from asthma symptoms and exacerbations and are commonly referred to as steroid-resistant asthma patients. As such, additional treatment options targeting the underlying asthma disease process, especially those delivered orally, would be of significant benefit to patients.HBC will continue to develop a product for treating steroid-resistant asthma in parallel with its COVID-19 clinical trials, progressing towards preclinical animal trials in Q3 2020 and based on a positive outcome, progressing to Phase 1 clinical trials in 2021. A large scientific and clinical evidence base has identified the white blood cells and related cytokines responsible for initiating and sustaining bronchial inflammation in different subtypes of asthma. As such, eosinophilic asthma is an ideal setting to test the potential benefit of the minor fraction within OmeGo® in terms of improved lung function, reduced exacerbation rates and even potentially reduced steroid usage. About OmeGo®OmeGo® contains the full spectrum of omega fatty acids including EPA, DHA and DPA offering benefits on human cholesterol levels including reduction of the CVD biomarker, oxLDL-GP1, for which HBC has global patent rights. Only OmeGo® contains all the lipid-soluble compounds found in fresh salmonid fish thus providing all of the health benefits seen when consuming an oily fish-based diet. HBC uses its proprietary enzymatic hydrolysis technology to sustainably extract all the nutrients from the fish and transforms them into high value health products for human and pet consumption.For further information, please contact:James Berger, Head of Investor Relations & Strategy at Hofseth BioCare ASA
Phone: +41 79 950 1034
E-mail: jb@hofsethbiocare.noDr. Crawford Currie, Medical R&D at Hofseth BioCare ASA
Phone: +44 7968 195497
E-mail: cc@hofsethbiocare.noAbout Hofseth BioCare ASA:HBC is a Norwegian biotech company that develops high-value ingredients and finished products. The ingredients are in various stages of discovery and preclinical development in collaboration with multiple clinics and university research labs in several countries. Lead preclinical and clinical candidates are in development toward treatment for iron-deficiency anemia, Gastro-Intestinal Inflammation (NEC/IBS/UC), prediabetes, age-related sarcopenia and osteoarthritis.The company is founded on the core values of sustainability, traceability and optimal utilization of natural resources. Through an innovative hydrolysis technology, HBC can preserve the quality of lipids, proteins and calcium from fresh salmon off-cuts. Hofseth BioCare's headquarters are in Ålesund, Norway with branches in Oslo, London, Zürich, Chicago, Menlo Park and Tokyo.HBC is listed on Oslo Stock Exchange Axess list with ticker "HBC". More information about Hofseth BioCare at hofsethbiocare.com and facebook.com/hofsethbiocareThis information is subject to the disclosure requirements pursuant to Section 5-12 the Norwegian Securities Trading Act

Severe Acute Respiratory Syndrome