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Tuesday, 19 January 2021 07:27

Bonus BioGroup received all the necessary approvals to conduct a clinical trial to evaluate MesenCure for the treatment of Covid-19

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Following safety and efficacy preclinical results of the unique drug product MesenCure, a therapy specifically developed by Bonus BioGroup for the life-threatening acute respiratory distress in coronavirus (Covid-19) patients and pneumonia;


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 a previous announcement, dated July 22, 2020 regarding the Company’s development of an advanced version of the drug product MesenCure, specifically developed to treat the life-threatening acute respiratory distress in coronavirus (Covid-19) patients and pneumonia, and subsequent to additional safety and efficacy preclinical results obtained, Bonus BioGroup is pleased to announce that on January 18, 2021, it has received the necessary approvals from the Israeli Ministry of Health and from Rambam Health Care Campus, Haifa, to conduct a phase I/II clinical trial to evaluate the safety and efficacy of MesenCure in the treatment of Covid-19 patients (hereinafter: “the clinical trial for the treatment of respiratory distress”).

The clinical trial for the treatment of respiratory distress will be conducted at Rambam Health Care Campus, Haifa, a leading medical center for the treatment of coronavirus patients, and will include up to 60 trial participants. The safety and efficacy of the drug product MesenCure will be evaluated in comparison to a control group.

During the clinical trial for the treatment of respiratory distress with MesenCure, three doses of the drug product will be administered intravenously to the treatment group. Parameters that will be followed during the trial period include, respiratory functions, inflammatory parameters that demonstrate the attenuation of the cytokine storm characteristic of Covid-19 disease, general parameters indicative of the disease course, as well as the shortening of the hospitalization period and patient survival.

The clinical trial protocol is based, among others, on preclinical studies performed on a lethal pneumonia animal model treated with MesenCure that demonstrated a successful recovery of the animals and their rescue from death. A significant improvement in the animals’ health was observed following the administration of the second out of a total of three MesenCure doses evidenced in the improvement in all tested clinical parameters and survival.

The safety of MesenCure was demonstrated in a preclinical toxicity study, performed by an independent laboratory under the stringiest regulatory standards (Good Laboratory Practice), in which three doses of MesenCure were given, each at a dose 30-times higher compared to the dose that will be administered during the clinical trial for the treatment of respiratory distress.

MesenCure’s efficacy stems from the primed mesenchymal stromal cells that comprise the drug product, and which are attained by a unique combination of biological and physical growth conditions, while shortening the cells’ manufacturing time and maintaining their safety.

As result of the third coronavirus wave and the failure of the health systems in numerous countries to treat the increasing numbers of Covid-19 and pneumonia patients, the drug product MesenCure may significantly decrease the overall numbers of severe patients and patients in need of ventilation. Hence, MesenCure may support the health care systems around the world by facilitating the treatment of Covid-19 disease and pneumonia, while reducing the need for lockdowns, consequently minimizing societal and economic burden.

The company estimates that the medical treatment of coronavirus patients will comprise a combination of different protective measures which will include vaccines, drug therapies and supportive medical equipment.

Bonus BioGroup’s drug product MesenCure, is designed to treat respiratory infections, whether the source of the infection is the novel coronavirus or any other virus, a bacterium or exposure to other contaminants. Thus, MesenCure may be used to treat a wide range of indications, including, lower respiratory tract infections as well as asthma and chronic obstructive pulmonary disease, which together, represent a global market which by 2026 is expected to exceed US$ 43 billion per year[1],[2],[3], even before the expected impact of the novel coronavirus.

Since its establishment, Bonus BioGroup is developing cell-based therapies and tissue-engineered products for bone regeneration. The main component of the viable bone graft are mesenchymal stromal cells isolated from the patient’s adipose tissue. During the beginning of the Covid-19 pandemic outbreak, the Company started to study these mesenchymal cells, isolated from the adipose tissue of healthy donors, and their priming in order to enhance their potential to attenuate the inflammatory responses, and foremostly, respiratory inflammations and the hyper-inflammatory response – the cytokine storm prevalent in Covid-19 disease and other inflammatory diseases.

Bonus BioGroup applied in the development of MesenCure a variety of unique technologies and knowledge, some of which are currently in development by the Company, and some of which are part of the Company's rich intellectual property, which includes fourteen approved patents and eighteen patent applications, in many countries around the world.

Company estimations regarding 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 product, including the conduction of clinical trials, and the attaining of a drug product that can be medically applied in humans, 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 these 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)

[1] https://www.coherentmarketinsights.com/press-release/global-chronic-obstructive-pulmonary-disease-copd-treatment-market-to-surpass-us-218-billion-threshold-by-2026-1411

[2] https://www.bloomberg.com/press-releases/2019-06-13/global-asthma-therapeutics-market-to-surpass-us-20-4-billion-by-2026-coherent-market-insights

[3] https://www.reportsanddata.com/report-detail/acute-respiratory-distress-syndrome-ards-market

Read 890 times Last modified on Thursday, 11 March 2021 07:47