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Wednesday, 11 August 2021 13:01

The Israeli Ministry of Health approved the joining of additional medical centers to the Phase II clinical trial for severe Covid-19 evaluating Bonus BioGroup's product MesenCure

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As Covid-19 infections are rising and in light of significant improvements in the health and recovery of severe Covid-19 patients treated with MesenCure;
The Israeli Ministry of Health approved the joining of additional medical centers to the Phase II clinical trial for severe Covid-19 evaluating Bonus BioGroup's product MesenCure


Bonus BioGroup (TASE: BONS) is a clinical-stage Israeli biotechnology company, engaged in research and development of biomedical tissue-engineered and cell therapy products. 

Following the immediate report dated May 27, 2021, and the immediate report dated July 7, 2021, regarding significant improvement in the health and recovery chances of severe Covid-19 patients treated with the cell therapy MesenCure, Bonus BioGroup is pleased to announce that the Israeli Ministry of Health approved the joining of additional medical centers to the phase II clinical trial for evaluating the efficacy and safety of MesenCure in the treatment of Covid-19 patients suffering from life-threatening pneumonia and respiratory distress (hereinafter: "the clinical trial for the treatment of respiratory distress").

Following the complete success of the phase I/II clinical trial for the treatment of respiratory distress, demonstrating MesenCure safety and efficacy in all parameters tested, the phase II clinical trial has commenced at Rambam Health Care Campus, in Haifa.

The ongoing clinical trial for the treatment of respiratory distress will include up to 50 severe Covid-19 patients with life-threatening respiratory distress, and will evaluate the efficacy and safety of MesenCure. The participating patients receive three doses of MesenCure, administered intravenously. The parameters evaluated in the clinical trial for the treatment of respiratory distress include, among others: respiratory functions, inflammatory parameters that indicate the attenuation of the cytokine storm characteristic of Covid-19 infection, general parameters that indicate the course of the disease, shortening of the hospitalization time, and increased patients' survival.

The efficacy of MesenCure stems from the purposeful activation of the mesenchymal cells comprising the drug product, using an innovative and unique combination of biological and physical growth conditions.

MesenCure is intended to treat life-threatening respiratory distress, regardless its source; whether caused by the original Covid-19 strain or any other variant, by another virus, or whether a bacterial infection or chemical insult causes it.

Given the emergence of more virulent coronavirus strains, which will lead to further infection waves, and due to a worldwide-vaccines shortage that is expected to last several years until about 70% of the world population is vaccinated as required for herd immunity, according to experts' assessments, the company estimates that in the coming years, the vaccines will have no significant impact on the market positioning of MesenCure.

Experts' opinions presented in January 2021 in the prestigious scientific journal Nature, support the projection that despite vaccination, Covid-19 will not disappear but become an endemic disease, with stable occurrences, similar to influenza, affecting more than 10% of the population each year. The company estimates that even after herd immunity for the Covid-19 virus is achieved and maintained, a normal incidence of millions of severe Covid-19 patients is expected worldwide each year, which may be the target population for MesenCure.

In addition, MesenCure may be used for the treatment a wide range of indications, including lower respiratory tract infections, asthma, and chronic obstructive pulmonary disease, which together represent a global market that by 2026 is expected to exceed USD 43 billion per year,,, without including the Covid-19 effect.

All patients in the phase I/II Mesencure clinical trial were diagnosed with severe Covid-19 infection before MesenCure treatment. In addition, except for one participant, all suffered from other diseases known as risk factors for serious illness, complications, and mortality of over 35%.

Covid-19 causes in patients with severe illness a high incidence of pneumonia and damage to other tissues, including the heart and kidneys, at a rate ten times higher than in milder patients, as well as muscle damage and venous thromboembolism (VTE), which can lead to multiorgan dysfunction and death, regardless of the respiratory distress.

The first part of the clinical trial for the treatment of respiratory distress demonstrated that each of the three MesenCure administrations resulted in a significant decrease of the diffuse inflammation, as well as a cumulative effect. This was shown by chest radiographic images and by the demonstrated improvement in parameters indicative of tissue damage, pointing to a reduced risk of multiorgan dysfunction, heart damage, kidney damage, and venous thromboembolism.

The healed lungs of Covid-19 patients treated with MesenCure, highlighted the superior efficacy of MesenCure, compared to other treatments, as shown in the significant decrease (p <0.0001) in the area of ​​diffuse lung inflammation, demonstrated by chest radiographs, from a median surface area of ​​about 55% measured before treatment to a median rate of about 15% of the lung area within about only 5 days following treatment start, and up to a negligible median rate of about 1% of the lung area, about a month after treatment start.

The improvement in respiratory functions of Covid-19 patients treated with MesenCure was evident by a significant increase (p = 0.0086) in the rate of blood oxygen saturation (SpO2), from acute respiratory distress before treatment to a blood oxygen saturation of about 95% following treatment with MesenCure.

In addition to improvements in the objective parameters of Covid-19 patients treated with MesenCure, improvement was also demonstrated in all subjective parameters in the patients' health assessments, including their mobility, ability to care for themselves, and performance of routine operations.

Since its establishment, Bonus BioGroup has been engaged in cell therapy and tissue engineering to achieve the regeneration and reconstruction of bone tissue. The central building block used to produce a viable bone graft is mesenchymal cells isolated from the patient's adipose tissue. With the outbreak of the global Covid-19 pandemic, the company began experimenting with these mesenchymal cells, that are isolated, in this case, from adipose tissue of healthy donors, and are activated to enhance their ability to reduce inflammatory processes, including the pneumonia and the cytokine storm accompanying the inflammation in Covid-19 patients and others.

In the development of the drug product MesenCure, Bonus BioGroup utilizes a variety of unique technologies and knowledge, some of which are currently developed by the company, and some of which form part of the company's wealthy intellectual property, including six families of patents and patent applications, consisting of twenty-five approved patents and eighteen patent applications in many countries around the world.

Company estimations regarding the forward-looking statement

Bonus BioGroup's assessments regarding the therapeutic effect of MesenCure and /or its marketing potential, the company's ability to continue the development of the drug, including the conduct of clinical trials, and the manufacturing of a high-quality clinical-grade drug product, for the time periods expected to conduct any stages in any trial, are a forward-looking statement, as defined by the in the securities law 1968, which is based on the company's estimates and on the information in its possession at the time of reporting.  

There is no certainty that this information will be realized, in whole or in part, among others, due to dependence on third parties actions that are not under the control of the company, the possibility of delay in obtaining relevant regulatory approvals and / or a change in the relevant conditions and / or feasibility studies that the company may conduct, and / or delay in conducting of studies and / or the need for further studies and / or 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 trials and / or its results.

Sincerely,

Bonus BioGroup

By: Yossi Rauch (Chairman of the Board) and Dr. Shai Meretzki (CEO and Director)

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