PharmaMar Has Announced That the Spanish Medicines Agency Has Authorized the APLICOV-PC Clinical Trial With Aplidin® (Plitidepsin) for the Treatm

- The objective of the trial is to evaluate the efficacy and safety of plitidepsin in patients with COVID-19 requiring hospital admission

- Plitidepsin recently obtained positive results from in vitro studies on the human HCoV-229E coronavirus, carried out at the National Biotechnology Center (Centro Nacional de Biotecnología) of the Spanish National Research Council (CSIC)

MADRID, April 28, 2020 /PRNewswire/ -- PharmaMar (MSE: PHM) has announced the start 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).

This is a multicenter, randomized, parallel, open-label study to evaluate the safety profile and efficacy of three doses of plitidepsin in patients with COVID-19 requiring hospital admission.

Three hospitals from Madrid (Spain) will participate in the study. Three cohorts of patients with three different dose levels will be included in the study to assess the efficacy and safety of plitidepsin at each dose level administered in patients admitted to hospitals with COVID-19.

During this first stage, 27 patients will be recruited, to whom three doses will be administered. The viral load 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 after discussion with the regulator, with a larger cohort of patients.

On March 13(th), 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 reproduction. The studies were carried out at the National Biotechnology Center of the Spanish National Research Council (CSIC) (see press release []).

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 propagation to the rest of the cells unviable.

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About PharmaMar

Headquartered in Madrid, PharmaMar is a biopharmaceutical company, focused on oncology and committed to research and development which takes its inspiration from the sea to discover molecules with antitumor activity. It is a company that seeks innovative products to provide healthcare professionals with new tools to treat cancer. Its commitment to patients and to research has made it one of the world leaders in the discovery of antitumor drugs of marine origin.

PharmaMar has a pipeline of drug candidates and a robust R&D oncology program. It develops and commercializes Yondelis(®) in Europe and 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). To learn more about PharmaMar, please visit us at [about:blank].

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