Madrid-based PharmaMar has submitted the protocol for a Phase 2 trial to the Spanish Medicines and Healthcare Products Agency (AEMPS) to test its multiple myeloma therapy Aplidin (plitidepsin) in people with COVID-19 pneumonia.
The trial, named APLICOV, aims to recruit 160 patients across multiple sites in Spain and assess if Aplidin reduces the proportion of patients who progress to acute respiratory distress syndrome, a type of respiratory failure that causes patients to need mechanical ventilation and admission into intensive care units.
APLICOV will test two Aplidin doses, given via into-the-vein infusions for five consecutive days.
“This health emergency requires us all to work together to stop this pandemic. Each of us is obliged to do our utmost,” José María Fernández, PhD, president of PharmaMar, said in a press release. “As soon as we receive authorization from the AEMPS, we will be able to start the clinical trial with plitidepsin and we hope that it can become an effective weapon against COVID-19.”
Aplidin is approved in Australia in combination with dexamethasone to treat multiple myeloma patients who failed or became resistant to other therapies. The approval was granted after this combination showed significant survival benefits over dexamethasone alone in the ADMYRE Phase 3 trial (NCT01102426).
Originally isolated from the sea squirt (Aplidium albicans), the therapy works by binding eEF1A2, a protein found on the surface of multiple myeloma cells, thereby interfering with their growth and viability.
But recent studies carried out at the National Biotechnology Centre of the Spanish National Research Council (CSIC) by Luis Enjuanes, MD, Isabel Solá, MD, and Sonia Zúñigasuggest, PhD, suggest that Aplidin may also have antiviral properties.
With the human coronavirus HCoV-229E — which uses mechanisms that closely resemble those of the SARS-CoV-2 virus that’s causing the current pandemic — researchers found that the EF1A protein is key for the replication of this virus, and for its spread to other cells. The results confirm a hypothesis, initially proposed in 2012, suggesting that due to its abundance in cells, eEF1A may be hijacked by viruses for their own benefit.
Notably, studies in infected cells grown in the lab showed that Aplidin can inhibit viral replication and spread to other cells in very small doses, which is a good indicator that the doses needed to treat COVID-19 patients will not cause severe toxicity.
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