PharmaMar announces that the Spanish Medicines Agency has authorized the APLICOV-PC clinical trial on Aplidin® (plitidepsin) for the treatment of patients with COVID-19

MADRID, April 28, 2020 / PRNewswire / – PharmaMar (MSE: PHM) announced the start of the APLICOV-PC clinical trial of Aplidin® (plitidepsin) for the treatment of patients with COVID-19, who has been authorized by the Spanish Agency for Medicines and Health Products (AEMPS).

This is a multi-center, randomized, parallel and open-label open study to assess the safety profile and efficacy of three doses of plitidepsin in patients with COVID-19 requiring hospitalization.

Three hospitals in Madrid (Spain) will participate in the study. Three cohorts of patients who received three different doses will be included in the study to assess the efficacy and safety of plitidepsin for each dose administered to patients hospitalized with COVID-19.

During this first phase, 27 patients will be recruited and will be given three doses. Patients’ viral load will be measured before and after treatment, as well as a series of other parameters relating to their clinical course. If the results are positive at this early stage, the trial will continue at the optimal dose after discussion with the regulatory authority, on a larger cohort of patients.

On March 13, the company announced the results of studies in vitro plitidepsin on the human coronavirus HCoV-229E, which has a multiplication and propagation mechanism very similar to that of SARS-CoV-2, since both use the eEF1A protein to reproduce. The studies were carried out at the National Biotechnology Center of the Spanish Higher Council for Scientific Research (CSIC) (see the press release).

Plitidepsin works by blocking the protein eEF1A, found in human cells, which SARS-CoV-2 uses to reproduce and infect other cells. This inhibition should prevent the virus from reproducing inside the cell, making its spread to the rest of the cells unsustainable.

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Legal disclaimer

This press release does not constitute an offer to sell or a solicitation of an offer to buy securities, and does not constitute an offer, solicitation or sale in a jurisdiction where such an offer, solicitation or sale would be illegal before registration or qualification under the securities laws of that country.

About PharmaMar

Based in Mardid, PharmaMar is a biopharmaceutical company focused on oncology and dedicated to research and development which draws its inspiration from the sea in order to discover molecules with anti-tumor activity. It is a company that is looking for innovative products to provide healthcare professionals with new tools for the treatment of cancer. His commitment to patients and research has made him one of the world leaders in the discovery of anti-tumor drugs of marine origin.

PharmaMar has a portfolio of drug candidates and a robust research and development program in oncology. It develops and markets Yondelis® in Europe and has other programs in the clinical development phase for several types of solid cancer: lurbinectedin (PM1183), PM184 and PM14. PharmaMar has subsidiaries in Germany, Italy, France, Switzerland, Belgium, Austria and the United States. PharmaMar also owns other companies 100%: GENOMICA, a molecular diagnostic company, and Sylentis, dedicated to the research of therapeutic applications for gene extinction. For more information about PharmaMar, visit www.pharmamar.com.

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