PharmaMar explores adding a fourth therapy to its current platform.
Madrid-based PharmaMar announced the intention to begin the study of an innovative quadruple combination featuring the company’s Aplidin® (plitidepsin) and three other proven compounds used in combination to treat multiple myeloma.
PharmaMar explained the study’s primary goal was to evaluate the recommended dose (RD) and the efficacy and safety profile of Aplidin in combination with pomalidomide, bortezomib and dexamethasone, all three, said the company, indicated for early-stage myeloma treatment. According to PharmaMar, Aplidin will be effective as a front-line combination because of its proven performance as an adjunct to other combination therapies, its own safety profile, and the absence of hematological toxicity. Because of those factors, said PharmaMar, Aplidin can be “administered at maximum dose with the corresponding increase in efficacy of the therapy.”
On its website, PharmaMar described Plitidepsin as an investigational anticancer agent of marine origin. With a specific ability to bind itself to eEF1A2 and target the non-canonical role of that particular protein, the company said, plitidepsin kills tumor cells through apoptosis. With its marketing authorization application accepted by the EMA in 2016, Aplidin is already in triple combination Phase Ib trial for refractory multiple myeloma with bortezomib and dexamethasone. Aplidin, notes PharmaMar, has received orphan drug status by both US and European regulators.
Centers in Spain and the Czech Republic will be taking part in the trials. PharmaMar’s Clinical Department Business Unit Director Arturo Soto explained, that going forward, it is likely that the treatment of multiple myeloma will be based on combined therapies: "Aplidin is an ideal compound for combining with other drugs that are commonly used in the treatment of multiple myeloma … With this molecule, we can provide the actual therapeutic arsenal with a different mechanism of action to attack myeloma cells.”