PharmaMar Launches Aplidin Quadruple Combo Trial in Myeloma

PharmaMar is launching a clinical trial to explore its investigational therapy Aplidin (plitidepsin) in a quadruple combination treatment for multiple myeloma.

The four compounds involved in the combo all have different ways to attack the cancer, allowing better results than individual therapies, according to PharmaMar.

Aplidin, compared to most cancer treatments, does not reduce blood cell counts and is ideal to combine with other therapies, according to the company’s data of its safety in combination with two other compounds.

The goals of the early-phase trial, which will take place at centers in the Czech Republic and Spain, are to evaluate the recommended dose of Aplidin along with the effectiveness and safety of the combination treatment. Researchers will also evaluate biological markers of treatment response or resistance.

In the study, Aplidin will be given along with Pomalyst (pomalidomide), Velcade (bortezomib), and dexamethasone. These drugs are all used in early myeloma disease stages.

PharmaMar has already initiated testing Aplidin in a Phase 1b trial (NCT02100657) of a triple combination with Velcade and dexamethasone in relapsed or refractory myeloma patients. This trial is taking place at centers in Spain and France.

“Aplidin is an ideal compound for combining with other drugs that are commonly used in the treatment of multiple myeloma, given the absence of hematological toxicity, its excellent safety profile, and good tolerability,” Dr. Arturo Soto, director of the Clinical Department at PharmaMar Business Unit, said in a press release.

“With this molecule, we can provide the actual therapeutic arsenal with a different mechanism of action to attack myeloma cells,” he added.

Aplidin is a compound with anticancer properties that researchers originally isolated from the marine invertebrate Aplidium albicans. It binds to a protein called eEF1A2, which cells use when synthesizing proteins. By preventing protein production in tumor cells, Aplidin causes cell death and tumor regression.

The drug has also been tested in combination with the anti-inflammatory drug dexamethasone in a Phase 3 trial (NCT01102426) called ADMYRE. The combination was found to be better than dexamethasone alone in preventing disease progression or death, prompting PharmaMar to seek Marketing Authorization for using the combination in multiple myeloma patients in the European Union.

The company’s expanded efforts with additional combination therapies indicate that PharmaMar believes Aplidin to have an even greater potential when combined with several other treatments.

“In the future, the treatment of multiple myeloma patients will be based on combined therapies,” Soto said.