Spanish Medicines Agency Authorizes the APLICOV-PC Clinical Trial with Plitidepsin for the Treatment of Patients with COVID-19

May 3, 2020 | Coronavirus, COVID-19, PharmaMar, Plitidepsin, Spain

Spanish Medicines Agency Authorizes the APLICOV-PC Clinical Trial with Plitidepsin for the Treatment of Patients with COVID-19

The National Biotechnology Center (Centro Nacional de Biotechnologia) of the Spanish National Research Council (CISC) recently revealed positive results involving the investigation of plitidepsin in vitro studies on the human HCoV-229E coronavirus. Thereafter, Spanish biotech PharmaMar announced that the Spanish Medicines Agency has authorized the APLICOV-PC clinical trial with Aplidin® (plitidepsin) for the treatment of patients with COVID-19. The company seeking to investigate the efficacy and safety of plitidepsin in patients with COVID-19 requiring hospital admission.

In Vitro Studies at Centro Nacional de Biotechnologia

Back on March 13, the company announced the results of in vitro studies of plitidepsin on the human HCoV-229E coronavirus, which has a very similar multiplication and propagation mechanism to SARS-CoV-2, as they both use the eEF1A protein for their 1 reproduction. These studies were conducted at the National Biotechnology Center of the Spanish National American Research Council (CSIC).

Relevance of Plitidepsin

Identified by the University of California, San Francisco (UCSF) QBI research group as a potential candidate for a COVID-19 target drug, plitidepsin acts by blocking the protein eEF1A present in human cells, which is used by SARS-CoV-2 to reproduce and infect other cells. By means of this inhibition, the expectation is that reproduction of the virus inside the cell is prevented, making this prorogation to the rest of the cells unviable.

The Study

PharmaMar (MSE: PHM) announced the commencement of the APLICOV-PC clinical trial with Aplidin® (plitidepsin), for the treatment of patients with COVID-19, which has been authorized by the Spanish Medicines and Healthcare products Agency (AEMPS).  

The multicenter, randomized, parallel, open-label study will evaluate the safety profile and efficacy of three doses of plitidepsin in patients with COVID-19 requiring hospital admission. The clinical investigational sites include three (3) hospitals from Madrid, Spain.

The three cohorts of patients with three different dose levels will be included in this study to assess the efficacy and safety of plitidepsin at each dose level administered in patients admitted to the hospitals with COVID-19. During the first stage, 27 patients will be recruited, to whom three doses will be administered. The viral loads of the patients will be measured before and after the treatment, as well as a series of other parameters for clinical evolution.

If the results were positive at this early stage, the trial would continue at the optimal dose post discussion with the regulator, with a larger cohort of patients.

Who is PharmaMar?

Based in Madrid, Spain, the biopharmaceutical company PharmaMar is focused on oncology and committed to research and development, which takes its inspiration from the sea to discover molecules with antitumor activity. The company seeks innovative products to provide healthcare professionals with new tools to treat cancer.  It positions itself as a world leader in the discovery of antitumor drugs of marine origin.

Pipeline

PharmaMar’s pipeline of drug candidates along with what it touts as a robust R&D oncology program has led to commercial products such as Yondelis® in Europe—the company has other clinical-stage programs under development for several types of solid cancers: lurbinectedin (PM1183), PM184 and PM14. With subsidiaries in Germany, Italy, France, Switzerland, Belgium, Austria and the United States. PharmaMar wholly owns other companies: GENOMICA, a molecular diagnostics company; Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi).

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Source: PharmaMar

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