Analyx: Encouraging results in an experiment in Allocetra – the capital market

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Reports the publication of an article entitled “Apoptotic cells for therapeutic use in cytokine storm associated with sepsis” on medRxiv. The article presents definitive data on positive safety and efficacy from a Phase Ib clinical trial that has been completed, to the examination of Allocetra in patients with severe sepsis. The main objective of the experiment was to determine the safety and tolerability profile of Allocetra. In addition, effects on mortality, organ failure, and number of days of general hospitalization and intensive care were also measured. In the Allocetra treatment group, no patient died during the trial period compared with 27% mortality at 28 days in the control group; The length of hospitalization in intensive care was almost 60% shorter.

According to the report, the final analysis is based on a comparison of data from 10 patients hospitalized with intensive care and treated with Allocetra, compared to 37 patients in a control group (age, gender, systems collapse index and source of infection) in currently accepted treatment at the same hospital during 2014 -2019. The clinical trial was conducted at Hadassah Medical Center, one of the largest hospitals in Israel.

Below is a summary of the findings as published.

mortality
The APACHEII – Acute Physiology and Chronic Health Evaluation Index of the Allocetra group of patients was 12.3, and the probability of mortality of at least one patient in the Allocetra treatment group was estimated at 85%, based on the medical staff’s assessment of intensive care at admission. Despite this, no patient (0%) treated with Allocetra died during the trial period (28 days), compared with 27% mortality at 28 days in the control group.

Sepsis and organ collapse
Each of the patients treated with Allocetra had 2 to 5 different collapses in the body systems during hospitalization in intensive care. All patients (100%) of Allocetra patients experienced a rapid and complete recovery from the septic condition and from any organ failure that was present during the initial hospitalization in intensive care. Despite the similarity in the system crash index (SOFA) initially between the Allocetra patients and the control group (3.4 vs. 3.47), not a single patient in the Allocetra experienced an increase in the system collapse index, while most of the patients in the control group recorded worsening in the system collapse index. The aggravation in the mean system collapse index in patients in the control group was about 100% compared to their condition at the time of hospitalization in intensive care compared to zero (0%) aggravation in patients treated with Allocetra.

Duration of hospitalization in intensive care
Intensive care hospitalization time among patients treated with Allocetra was significantly shorter with a mean of 4.7 days compared with 11.1 days of hospitalization among the control group, a decrease of 58%. The patient who was treated with Allocetra and responded more slowly than all the patients in the Allocetra group was released from intensive care after 8 days from the date of hospitalization, while approximately 50% of the control group were still in intensive care after 21 days.

Cytokines / chemokines / immunological modulators / stress factors
As expected in sepsis cases, most patients treated with Allocetra had high levels of cytokines, chemokines, immunological modulators and stress factors, some pro-inflammatory and some anti-inflammatory, which showed a return to normal levels during patients’ recovery from sepsis.

safety
Allocetra treatment has been shown to be safe and tolerable, with no serious and unexpected side effects and no serious events.

Prof. Dror Mevorach, Chief Medical Officer at Annelbex: “We are excited to see such profound and stable responses in a very sensitive and extremely difficult to treat septic population, achieving statistically significant differences compared to the control group. We believe that Allocetra is positioned as a potential clinical option for treating sepsis, which is a clinical condition with poor results and currently ineffective.”

Dr. Oren Hershkovich, CEO of the company: “The strong results from this trial are very encouraging, and we are pleased that they are now available for detailed review in medRxiv. These results, together with the intermediate and final results from Phase Ib trial in Corona patients in critical and severe condition, conclude that Allocetra has the potential to be a substantial solution in a variety of clinical indications. “Their pathology is very much in line with ‘cytokine storms’ and excessive immune responses.”

Sepsis is defined as a dysfunction of an organ in a life-threatening manner, caused by an abnormal response of the immune system to an infection. Sepsis has been defined by the World Health Organization as a disease of global priority, and there is currently no FDA-approved treatment for it. Sepsis is the third leading cause of death in the United States after heart disease and cancer, affecting approximately 1.7 million adults in the United States each year. Various studies have estimated that more than 50% of severe sepsis cases in hospitals end in death.