Bonus BioGroup receives approval to expand phase II


TEL AVIV, ISRAEL, 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 suffering from life-threatening pneumonia, acute respiratory distress, and related complications caused by the immune system’s hyperinflammatory response (cytokine storm) to the virus.

The Israeli Ministry of Health’s decision to use MesenCure coincides with a dramatic increase in infections and hospital stays 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 at the height of the pandemic. Thus, while countries around the world are examining viable alternatives to major economic shutdowns, the focus has been on establishing one 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 were fully successful in treating severe COVID-19 patients at the Rambam Health Care Campus in Haifa. All study participants were enrolled with severe COVID-19 and 90% had comorbidities that posed an increased risk of serious illness, complications, and a mortality rate of over 35%. Despite these significant complication factors, patients were discharged from hospital a median of one day after MesenCure treatment.

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

In addition to its direct impact on mitigating hyperinflammation, MesenCure has proven extremely successful in improving additional parameters such as patient prognosis, recovery and chance of survival. In addition, patients reported improvements in subjective parameters, including mobility, self-care ability, and performance in routine surgery.

Given the apparent effectiveness of MesenCure in treating severe COVID-19 patients with pre-existing medical conditions and high-risk comorbidities, this novel treatment was embraced as a potential solution to relieve overburdened hospital systems. In this way, MesenCure can help prevent the imposition of economically damaging measures such as general bans or closings. In the weeks since the phase I / II study was completed, Bonus BioGroup has started a phase II clinical study in which up to 50 participants with severe COVID-19 will participate to further evaluate the efficacy and safety of MesenCure.

MesenCure from Bonus BioGroup comes from the cutting edge areas of regenerative medicine and cell therapy and consists of allogeneic mesenchymal stromal cells that have been prepared to improve their immunomodulatory abilities. Once injected into the patient, the cells target the inflamed lungs, squeezing the cytokine storm and promoting healing of the respiratory system and other internal organs affected by COVID-19.

In addition to its current use in infections caused by SARS-CoV-2 variants, MesenCure has the potential to be applicable to a number of other diseases. These conditions include asthma, chronic obstructive pulmonary disease, and other lower respiratory diseases caused by viruses, bacterial infections, or chemical exposure. Beyond the current demand for therapeutic solutions for COVID-19, MesenCure’s potential global market is projected to exceed $ 43 billion by 2026.

The decision to expand MesenCure’s Phase II trial to medical centers across Israel shows the high hopes that both private and public stakeholders are placing in the use of this revolutionary treatment for a wide variety of diseases and illnesses. Additionally, as the prospect of a COVID-19-free world fades from the immediate horizon, MesenCure could be key to lowering the rate of serious illness and hospital admissions to keep public health systems within their capacities while inflicting further rounds of devastating economic closings prevent against the background of the global increase in the delta variant.

About Bonus BioGroup

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

Forward-looking statement

Bonus BioGroup’s assessments of the therapeutic effects of MesenCure and / or its commercialization potential, the Company’s ability to continue developing the drug, including conducting clinical trials, and the achievement of a drug that can be used medically in humans for the periods, in which processes are expected to be carried out, a forward-looking statement within the meaning of the Securities Act of 1968, which is based on the estimates of the company and the information available to it at the time of reporting.

There is no certainty that this information will be realized in whole or in part due to, among other things, reliance on the actions of third parties beyond the control of the Company, the possibility of a delay in obtaining relevant regulatory approvals and / or a change in the relevant terms and conditions / or feasibility studies that the company may conduct and / or delays in conducting studies and / or the need for further studies and / or the failure of studies and / or technological changes and / or development and marketing of similar and / or more effective competing products and / or lack of availability of resources and / or realization of any of the risk factors related to research and / or studies and / or their results.

SOURCE: BioGroup bonus

Reference link: to-phase-ii-clinical-study-for-severe-covid-19-evaluation-bonus-biogroup-s-product-mesencure

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