Bonus BioGroup Receives Approval to Extend Phase II


TEL AVIV, ISRAELL, August 22, 2021 (GLOBE NEWSWIRE) – Bonus BioGroup LTD or “the Company” (BONS.TA), an Israeli clinical-stage biotechnology company, has received official approval from the Israeli Ministry of Health to expand its Phase II clinical trials for its MesenCure treatment to health centers and hospitals across the country. MesenCure is leveraging advances in cell therapy to treat COVID-19 patients with life-threatening pneumonia, acute respiratory distress, and associated complications caused by the immune system’s hyper-inflammatory response (cytokine storm) to the virus.

The Israeli Ministry of Health’s decision on MesenCure coincides with a dramatic increase in infections and hospitalizations fueled by the more infectious Delta variant, which threatens to flood the public health system in Israel and around the world. Despite high vaccination rates, current infection rates are approaching those seen at the height of the pandemic. Therefore, as countries around the world explore viable alternatives to blanket economic shutdowns, the focus has shifted towards establishing a modus vivendi with COVID-19 which focuses on reducing the number of hospitalized and critically ill patients.

As announced in May and July 2021, Bonus BioGroup’s Phase I / II clinical trials have seen complete success in treating patients with severe COVID-19 at the Rambam healthcare campus in Haifa. All of the trial participants were admitted with severe COVID-19, and 90% had comorbidities with a high risk of serious illness, complications and a death rate of over 35%. Despite these important complicating factors, patients were discharged from the hospital after a median of one day after MesenCure treatment.

Despite the serious condition of the participating patients at admission, each of the three doses of MesenCure administered to the patients resulted in a significant decrease in diffuse inflammation. A cumulative effect was also recorded after the administration of each of the three doses to reduce the risk of multi-organ dysfunction, heart damage, kidney damage and venous thromboembolism caused by the body’s hyperinflammatory response to the virus.

Beyond its direct impact on alleviating hyper-inflammation, MesenCure has been shown to be very effective in improving additional parameters such as patient prognosis, recovery and chances of survival. Additionally, patients reported improvements in subjective parameters including mobility, self-care ability, and performance of routine operations.

Given the apparent effectiveness of MesenCure in treating severe COVID-19 patients with pre-existing conditions and high-risk co-morbidities, this new treatment has been seized as a potential solution to alleviate overburdened hospital systems. In doing so, MesenCure can help prevent the imposition of economically damaging measures such as blockages or general shutdowns. In the weeks following the conclusion of the Phase I / II trial, Bonus BioGroup has moved to a Phase II clinical trial that will include up to 50 participants with severe COVID-19 in order to continue to assess efficacy and the safety of MesenCure.

From the cutting edge fields of regenerative medicine and cell therapy, BioGroup Bonus MesenCure consists of allogeneic mesenchymal stromal cells that have been primed to enhance their immunomodulatory abilities. Once injected into the patient, the cells target the inflamed lungs, dampen the cytokine storm, and promote healing of the respiratory system and other internal organs affected by COVID-19.

Beyond its current application to infections with SARS-CoV-2 variants, MesenCure is potentially applicable to a range of additional conditions. These conditions include asthma, chronic obstructive pulmonary disease, and other diseases of the lower respiratory tract caused by viruses, bacterial infection, or exposure to chemical assault. Beyond the current demand for COVID-19 therapeutic solutions, the potential global market for MesenCure is expected to exceed $ 43 billion by 2026.

The decision to expand the Phase II trial of MesenCure to medical centers across Israel is indicative of the high hopes that stakeholders in the private and public sectors have for the use of this revolutionary treatment method in a wide variety of conditions. and different diseases. Additionally, as the prospects for a COVID-19-free world fade on the immediate horizon, MesenCure may be the key to reducing rates of serious illness and hospitalization to keep public health systems in their tracks. capacities while preventing further rounds of withered economic shutdowns. in the context of the worldwide rise of the Delta variant.

About Bonus BioGroup

Since its inception, Bonus BioGroup has worked on the development of cell therapies and tissue engineered products for bone regeneration. The main component of the viable bone graft developed by the Company consists of mesenchymal stromal cells isolated from the adipose tissue of the patient. During the outbreak of the COVID-19 pandemic, the Company began to study these mesenchymal cells and their potential applications to mitigate the associated hyper-inflammatory response (i.e. cytokine storm) caused by COVID-19 and other diseases. In developing MesenCure, Bonus BioGroup has applied a variety of unique technologies and proprietary knowledge, some of which are currently under development by the Company, and some of which are part of the Company’s broad intellectual property portfolio.

Forward-looking statement

Bonus BioGroup’s evaluations regarding the therapeutic effect of MesenCure and / or its commercialization potential, the Company’s ability to continue the development of the drug product, including the conduct of clinical trials, and the realization of a drug product that can be medically applied in humans, for the periods of time intended to complete the stages of a trial, are a forward-looking statement, as defined by the Securities Act of 1968, which is based on the estimates of the company and the information in its possession at the time of the report.

There is no certainty that this information will be realized, in whole or in part, among others, due to the reliance on actions of third parties which are not under the control of the Company, the possibility to delay obtaining the relevant regulatory approvals, and / or a change in the relevant conditions and / or feasibility studies that the Company may conduct, and / or a delay in carrying out studies and / or the need for studies complementary and / or failure of studies and / or technological changes and / or development and commercialization of similar and / or more effective competing products and / or lack of availability of resources and / or achievement of one of the risk factors linked to the research and / or trials and / or its results.

THE SOURCE: BioGroup Bonus

Reference link: towards-the-phase-ii-clinical-trial-for-severe-covid-19-evaluating-the-bonus-biogroup-s-product-mesencure

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