Europe has already twice rejected the drug that PharmaMar wants to test against Covid-19
The Spanish pharmacist PharmaMar has announced before the National Stock Market Commission that it has a therapeutic compound for the treatment of multiple myeloma, which due to its mechanism of action could be effective to treat the current outbreak of coronavirus.
The announcement has meant that the company, of Galician origin and based in Colmenar Viejo, has shot in more than 15% your rating in the Continuous Market throughout the day.
The trade name of this medicine is Aplidine, and its active substance is plitidepsin. The president of the company, José María Fernández, stressed that the drug is approved in Australia and in the approval phase in Taiwan, New Zealand or South Korea, but has omitted that, two years ago, the company tried to achieve its commercialization in Europe but he found the refusal by the European Medicines Agency.
The Committee for Medical Products for Human Use evaluated that the data provided did not show a clear improvement in the symptoms of multiple myeloma and several severe side effects. Therefore, he dictated that "the benefits of Aplidine do not offset its risks and we recommend that authorization be rejected to market it. "
The benefits of Aplidine do not offset its risks and we recommend that authorization to market it be rejected
The company requested that this decision, taken at the end of 2017, be reviewed. In spring 2018 received a refusal for the second time. Following this blow to its intention to commercialize Aplidine in the European continent, the pharmaceutical company filed a lawsuit in October 2018 against the European Commission for "clarify procedural safeguards and exam criteria which must be applied during a marketing authorization procedure before the European Medicines Agency ".
Antitumor … and antiviral?
PharmaMar bases its R&D on the extraction of new pharmaceutical compounds from the seabed. The company has been investigating plitidepsin since at least October 2005. Originally Aplidine was developed as an orphan drug, designed to treat a rare disease such as multiple myeloma.
To date, according to the public registry of clinical trials of the European Union, in total PharmaMar has conducted seven studies with this molecule, all focused on different types of tumor: melanoma, liposarcoma, myelofibrosis, multiple myeloma or aggressive non-Hodgkin lymphoma.
The big question is how a drug born and only tested against cancer could be effective against a coronavirus. The hypothesis they handle in the Spanish pharmaceutical company is that SARS-CoV-2 needs to reproduce or spread a protein called EF1A, present in infected cells. Precisely, its compound "would block EF1A and make virus reproduction within the cell unfeasible."
The relationship between this "elongation factor 1 A" and viral reproduction has been studied in similar coronaviruses, such as that of transmissible gastroenteritis in pigs.
Will the trials be ‘in vitro’ or will they involve patients? Would the medication work alone or in combination with another drug? At the moment, the company refers to the information contained in its statement to the CNMV and announces that will dedicate next month to test this hypothesis at the laboratory.
Mariví Mateos, hematologist at the University Hospital of Salamanca and author of several works on the therapeutic potential of plitidepsin, explains to El Confidencial that "we have used it in clinical research in myeloma and lymphoma but we don't have more information"than indicated in the statement.
The big question is how a drug born and only tested against cancer could be effective against a coronavirus
The company – which is also developing a coronavirus screening test – has in favor that the European Medicines Agency announced a month ago that it would support the development of new vaccines or treatments against Covid-19, although this also does not mean exactly one blank check to check out drugs that failed the green light at first. If the tests with Aplidine gave the expected result, PharmaMar would request a fast track for the rapid approval and placing on the market of the drug.
Although many hospitals and laboratories have announced promising drugs against the epidemic, so far in Spain only the lopinavir / ritonavir antiretroviral combo worked, applied to one of the infected patients at the Virgen del Rocío Hospital in Seville. There are no known, at the moment, antitumor medications that have proven effective against coronavirus.