Peaches Biotech publishes positive in vivo results of its drug PRS CK STORM of its drug PRS CK STORM against the cytokine storm associated with infectious processes, including COVID-19.
- These results, published in the journal Biomedicines, refer to the in vivo trial comparing the activity of PRS CK STORM versus placebo and Anakinra in animal models with lung damage and inflammation due to sepsis.
- The results show the high efficacy and safety of PRS CK STORM as a drug to prevent and treat cytokine storm associated with infectious processes of any type, including COVID-19.
- The cytokine storm associated with severe infectious processes is a serious global health problem. About 49 million cases are registered each year in industrialized countries, resulting in the death of more than 19 million people (1).
- Together with Peaches Biotech, the Centro de Investigación Biomédica de Aragón, the bioincubator of the Hospital Universitario de Fuenlabrada, as well as the Histocell advanced cell therapy plant in Bilbao have participated in this study.
- The company plans to start the clinical trial in several hospitals in Madrid in the coming months.
Madrid, May 10, 2022. Peaches Biotech Groupa Spanish company specialized in regenerative medicine and advanced therapies, is developing a series of biological drugs obtained by culturing different primary tissue cells and also mesenchymal stromal cells (MSCs) with M2 macrophages, to produce anti-inflammatory and anti-fibrotic effects, acting on the expression of pro-inflammatory cytokines of the innate immune system.
One of these products is PRS CK STORM, based on a patent developed by Peaches Biotech, from the co-culture between M2 macrophages (M2-polarized monocytes) and mesenchymal cells, the safety and efficacy of which has been tested in this animal study.
The magazine Biomedicines of the specialized scientific publishing group MPDI, publishes this study today under the title “Evaluation in an in vivo cytokine storm model of the safety and efficacy of the intravenous administration of PRS CK STORM (standardized conditioned medium obtained by co-culture of M2 macrophages from monocytes and mesenchymal stromal cells).)”.
The results obtained in the “in vivo” study, in the model generated with a bacterial lipopolysaccharide (LPS) as the causative agent of the acute lung damage caused by the cytokine storm in mice, show the high efficacy and safety of this product in combating the autoimmune reaction caused by the cytokine storm.
Histopathological analysis of the various organs of the mice, including the lungs, damaged after LPS administration showed how the damage was reversed, to the point of disappearance, in mice treated with PRS CK STORM at the highest dose of the three used in the trial. These results were clearly superior to those observed in mice treated with Anakinra (one of the current treatments for this type of pathology).
Taken together, the results show that PRS CK STORM, composed of a secretome of M2 macrophage co-culture with MSCs, at the doses chosen for the study, has demonstrated a strong ability to reduce acute inflammation in cytokine storms, associated with severe infections, such as COVID-19.
In addition, it has demonstrated its efficacy as an antifibrotic drug, preventing the medium and long-term negative consequences of acute inflammatory phenomena, by immunoregulating the activity of the innate immune system and improving its coordination with adaptive immunity.
In the words of Pedro Lapuente, Chief Scientific Officer of Peaches Biotech and main author of the publication: “cnderstanding how macrophages communicate and interrelate with mesenchymal stromal cells is a breakthrough that will allow us to accelerate clinical solutions to treat inflammatory processes, caused by an exacerbated immune reaction, which provokes a cytokine storm in response to infections. We have observed a recovery of damaged lung tissue that has surprised us and gives us great optimism for its clinical use in patients.”
PRS CK STORM has been manufactured by direct non-contact co-culture of M2 macrophages with MSCs in the facilities of Histocell, a company authorized to manufacture cell therapy drugs under good manufacturing practice (GMP).
This research is possible thanks to the public-private collaboration of Peaches Biotech with the Centro de Investigación Biomédica de Aragón (CIBA, Zaragoza) and the bioincubator of the Hospital Universitario de Fuenlabrada.
The company plans to start a clinical trial with this drug in the near future to evaluate its safety and efficacy in patients in several hospitals in Madrid.
(1) Sources:
Fleischmann, C.; Scherag, A.; Adhikari, N.K.; Hartog, C.S.; Tsaganos, T.; Schlattmann, P.; Angus, D.C.; Reinhart, K.; International Forum of Acute Care Trialists. Assessment of Global Incidence and Mortality of Hospital-treated Sepsis. Current Estimates and Limitations. Am. J. Respir. Crit. Care Med. 2016, 193, 259-272.
Rudd, K.E.; Johnson, S.C.; Agesa, K.M.; Shackelford, K.A.; Tsoi, D.; Kievlan, D.R.; et al. Global, regional, and national sepsis incidence and mortality, 1990-2017: Analysis for the Global Burden of Disease Study. Lancet 2020, 395, 200-211.