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On April 14th AstraZeneca announced that it would launch a randomized, global clinical trial to assess the potential of Calquence in treating patients with severe hyperimmune response (cytokine storm) infection with COCINIC infectionThe experimental design is based on strong scientific evidence to support the role of bruton tyrosine kinase (BTK) pathways in inflammatory cytokine production and based on encouraging early clinical dataCalquence is a new generation of highly selective BTK inhibitors currently used to treat certain types of blood cancersthe trial, called CALAVI, was based on early clinical data from Calquence, which showed that a reduction in inflammation caused by BTK inhibition appeared to reduce the severity of COVID-19-induced respiratory distressThe purpose of the trial was to evaluate the effectiveness and safety of adding Calquence to Optimal Support Therapy (BSC) to reduce mortality and auxiliary ventilation needs in patients with life-threatening COVID-19 symptomsCALAVI is a large, randomized, open-label, multi-center, global clinical trial using a two-part patient-centered design designed to evaluate the efficacy and safety of Calquence's combination of BSC and BSC single-drug treatment for respiratory complicationsThe clinical trial was designed to be developed quickly in record time to accelerate data collection and analysisThe first part was randomized grouped (2:1), which evaluated the use of Calquence in the non-intensive care unit (ICU) of COVID-19 patients compared to bSC single medicineThe second part assessed the patient slot in the ICU with more severe respiratory complications, BSC plus CalquenceThe main endpoint indicator is the use or death of auxiliary ventilationThe CALAVI trial is expected to begin recruiting in several countries in the United States and Europe in the coming daysDrWyndham HWilson of the National Cancer Institute (NCI) will lead the study, and DrLouis MStaudt will be a senior researcher"Through this trial, we are responding to the new insights of the scientific community and hope to demonstrate that adding Calquence to the best supportive treatment can reduce the need to put patients on the side of the ventilator and improve their chances of survival," said Jos? Baselga, executive vice president of oncology research and development at a
AstraZeneca It was the fastest start of any clinical trial in AstraZeneca's history "Given the role of BTK protein in regulating inflammation, inhibiting BTK with acalabrutinib has the potential to provide clinical benefits for patients with advanced COVID-19 lung disease," said Dr Louis M Staudt, Director of Lymphoma Atlarge Malignant Cancer Atrisk at the National Cancer Institute (NCI) As with all new treatments, it is necessary to collect data from clinical trials to understand the best and safest treatment options for patients Calquence is the next generation of selective BTK inhibitors Calquence combines with BTK to inhibit its activity In B cells, the BTK signal causes the path activation necessary for B-cell proliferation, transport, prosization, and adhesion Calquence has been approved in the United States and several other countries for the treatment of adult patients with chronic lymphocytic leukemia (CLL), in addition to calquence for adult patients with set cell lymphoma (MCL) who have received at least one previous treatment in the United States and several other countries in pulmonary macrophages, BTK is a key regulatory factor for the production of a variety of cytokines and chemokines, including TNFa, IL-6, IL-10 and MCP-1 BTK inhibition reduces the production of these cytokines and is therefore a promising strategy for reducing COVID-19 respiratory complications There is evidence that BTK-dependent macrophage signal transduction disorders may be central to THE SARS-COV-2 over-inflammation response and play a role in COVID-19 pneumonia and ARDS In macrophages, TLR3, TLR7, and TLR8 can identify single-stranded RNA from viruses such as SARS-COV-2 and activate NF-kB and IRF3 activation signals by BTK dependency, triggering the production of a variety of inflammatory cytokines and chemokines In order to support the inhibition of BTK, the therapeutic inhibition of BTK in patients with lymphoma leading to a decrease in pro-inflammatory cytokines and prosthesis factors Similar results were observed in mouse influenza models, where BTK inhibitors reduced these inflammatory media and protected mice from fatal acute lung damage References: Retrieved 2020-04-14, original title https:// : AstraZeneca anticancer drug for COVID-19, will launch large-scale clinical trials