PR83840

PharmaMar Has Announced That the Spanish Medicines Agency Has Authorized the APLICOV-PC Clinical Trial With Aplidin(R) (Plitidepsin) for the Treatment of Patients With COVID-19

MADRID, April 28, 2020 /PRNewswire=KYODO JBN/ --

- 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)

PharmaMar (MSE: PHM) has announced the start of the APLICOV-PC clinical trial

with Aplidin(R) (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 13th, 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

[http://pharmamar.com/wp-content/uploads/2020/03/PR_Results_Aplidin_coronavirus.

pdf]).

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.

Legal warning

This press release does not constitute an offer to sell or the solicitation of

an offer to buy securities, and shall not constitute an offer, solicitation or

sale in any jurisdiction in which such offer, solicitation or sale would be

unlawful prior to registration or qualification under the securities laws of

that jurisdiction.

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(R) 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 www.pharmamar.com.

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Source: PharmaMar