▷ Life Science Alliance magazine publishes plitidepsin results …


11.01.2022 – 23:57

PharmaMar

Madrid (ots/PRNewswire)

– The final results of the APLICOV-PC study (Phase I-II), which were published last May and which the company announced to the scientific community, demonstrate the safety of the use of plitidepsin in patients with COVID-19 and posit a positive one therapeutic effect on the course of the disease.

– PharmaMar confirmed n vitro- Plitidepsin activity against several variants, including Delta and Omikron.

– The Life Science Alliance journal was co-founded by Rockefeller University, the European Molecular Biology Organization (EMBO), and the Cold Spring Harbor Laboratory.

PharmaMar (MSE: PHM) today announced the publication of an article in Life Science Alliance magazine entitled ” Pre-clinical and randomized phase I studies of plitidepsin in adults hospitalized with COVID-19“[1] (Preclinical and Randomized Phase I Trials of Plitidepsin in Adults Hospitalized with COVID-19) announced a study of the In-vitro Contains activity of plitidepsin against the major SARS-CoV-2 variants, including the current Omicron variant.

According to the final data published in this article, plitidepsin has been shown to have potent antiviral activity in all variants at very low (nanomolar) concentrations, with a positive one In-vitro therapeutic index. These studies were carried out under the direction of Dr. Adolfo Garcia-Sastre, Professor in the Department of Microbiology at the Icahn School of Medicine in Mount Sinai, New York, NY, USA.

at In-vivo- Laboratory studies have also shown a preferential distribution of plitidepsin in lung tissue, the organ that is primarily affected in patients with COVID-19. These studies showed a decrease in viral replication that resulted in a 99% decrease in viral load in the lungs of animals treated with plitidepsin.

The article also looks at data from the APLICOV-PC clinical trial, which demonstrated the safety of plitidepsin in hospitalized patients with COVID-19. The study met the primary safety endpoint and demonstrated clinical efficacy; In addition, the study provided consistent evidence of plitidepsin-mediated effects on viral load, inflammatory pathways, and the normalization of lymphopenia.

45 patients were enrolled in this Phase I-II study, 86.7% of whom had moderate or severe illness. 41 patients (91%) had pneumonia, of which 32 (71% of the total sample) had bilateral pneumonia. Noteworthy are the data from 23 patients with moderate disease, 74% of whom were discharged from the hospital within the first week of treatment.

These results form the basis for the phase III clinical trial of NEPTUNO, for which patients are currently being recruited in 17 hospitals in Spain and 9 other countries, mainly in Europe and Latin America.

Dr. José F. Varona, Ph.D., in the Department of Internal Medicine, Hospital Universitario HM Montepríncipe in Madrid, emphasized: “Our clinical impression with plitidepsin in the APLICOV-PC study was confirmed, since after the administration of the drug – in addition to satisfactorily meeting the safety goals – we observed an improvement in symptoms and objective data (microbiological parameters, oximetry parameters and radiological parameters) in some cases. “

Adolfo García-Sastre, Ph.D., Professor in the Department of Microbiology at the Icahn School of Medicine in Mount Sinai, New York, commented, “It is noteworthy that the clinical data are consistent with the preclinical data suggesting a benefit of administering plitidepsin to patients with COVID- 19, and that plitidepsin has potent antiviral activity in preclinical models, not only for SARS-CoV-2 and its variants, including delta and omicron, but also against other coronaviruses. “

José María Fernández Sousa-Faro, Ph.D.., Chairman of PharmaMar, stated, “All of the data we have seen on plitidepsin so far confirms our original hypothesis about its antiviral activity. In studies conducted by both PharmaMar and leading researchers from around the world, plitidepsin has shown previously unknown effectiveness against SARS-CoV-2. We hope that patient recruitment for the NEPTUNO study will continue so that we can make this treatment available as soon as possible to all patients affected by the coronavirus and in need of inpatient treatment. “

[1] https://www.life-science-alliance.org/content/5/4/e202101200

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Original content by PharmaMar, transmitted by news aktuell


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