- 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 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).
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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solicitation of an offer to buy securities, and shall not
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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® 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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