TEL AVIV, ISRAEL / ACCESSWIRE / July 19, 2021 / Bonus BioGroup LTD (TASE:BONS), an Israeli clinical-stage biotechnology company, announced further improvements in key parameters measured in phase I/II Clinical Trials for its advanced cell therapy product, MesenCure. The latest report follows Bonus BioGroup’s May 27th announcement of MesenCure’scomplete success in the treatment of severe COVID-19 patients suffering from life-threatening pneumonia and acute respiratory distress. These new findings emerge against the backdrop of the rapid spread of new SARS-CoV-2 variants, a decrease in vaccine effectiveness, and a rise in infection rates worldwide.
The latest round of results revealed an improvement in parameters associated with patient prognosis, recovery, and chance of survival. More specifically, Bonus BioGroup noted a reduced risk of multiorgan dysfunction, heart/kidney injuries, and venous thromboembolism (VTE) in COVID patients after the first dose of MesenCure, with a cumulative effect observed when multiple doses were administered.
These findings were obtained after the Company completed an additional analysis of the results it obtained in a Phase I/II clinical trial held at the Rambam Health Care Campus in Haifa, Israel that was geared towards evaluating the safety and efficacy of MesenCure in the treatment of severe COVID-19 patients. In such cases, inflammation and tissue damage are detected not only in the lungs, but also in the heart and the kidneys at levels more than ten times higher than those observed in milder patients.
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Among the severe COVID-19 cases treated with the MesenCure,90% of the patients suffered from pre-existing conditions that increase the risk of severe illness and complications and carry a mortality rate of over 35%. Following treatment, these patients’ saw significant improvements in overall respiratory function and a rapid reduction in the area of diffuse lung inflammation. In addition to objective indices measured in the trial, patients treated with MesenCure reported notable improvements in subjective parameters used to assess general health including mobility, capacity for self-care, ability to perform routine actions, degree of pain, and anxiety.
These promising results were reinforced by Dr. ShadiHamoud, Head of the Research Unit and Deputy Director of the Department of Internal Medicine at Rambam Medical Campus, who stated: “The treatment results of MesenCure are thus far very impressive, and are significantly better compared to those achieved with other therapies. All patients treated with MesenCurewere in a severe condition and suffered from acute respiratory distress, diffuse pneumonia (as perchest radiograph), and blood parameters indicative of a cytokine storm. Moreover, about 90% of the trial participants suffered from comorbidities known as risk factors for increased disease severity, complications, and mortality.”
“If not for MesenCure, the patients’ prognosis was poor, with low chances of recovery and survival. However, thanks to the treatment with BonusBioGroup’s MesenCure, the patients have shown significant improvements in tested parameters and were released from the hospital only one day (per median calculation) following the treatment conclusion. Thus, the treatment withMesenCure showed good and surprising results that generated significant interest within other hospital departments. We hope to treat a large number of patients with this cell therapy method, and we will strive to extend its use to other applications as well.”
The effectiveness displayed by MesenCure derives from Bonus BioGroup’s enhancement of the mesenchymal cells that make up the drug via a unique combination of biological and physical growth conditions while shortening the cells’ total growth period that improves the treatment’s safety. As a consequence of the excellent outcomes witnessed in the phase I/II clinical trial, the Israel Ministry of health (IMOH) approved continuation to a Phase IItrials. This will include up to 50 additional severeCOVID-19 patients, and will be conducted at Rambam Health Care Campus under the supervision of Dr. Shadi Hamoud, the primary investigator in the Phase I/II trial.
About Bonus BioGroup
Since its establishment, Bonus BioGroup has worked to develop cell therapies and tissue-engineered products for bone regeneration. The main component of the viable bone graft developed by the Company are mesenchymal stromal cells isolated from the patient’s adipose tissue. During the outbreak of the COVID-19 pandemic, the Company started to study these mesenchymal cells and their potential applications to attenuating the associated hyper-inflammatory response (i.e., cytokine storm) provoked by COVID-19 and other diseases. In the development of MesenCure, Bonus BioGroup applied a variety of unique technologies and proprietary knowledge, some of which are currently in development by the Company, and some of which are part of the Company’s broad intellectual property portfolio, which includes fourteen approved patents and eighteen patent applications in many countries around the globe.
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 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.
SOURCE: Bonus BioGroup
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