More hopeful news in myeloma treatment with the advancement of 's drug Aplidin® (plitidepsin) for refractory disease. The company is located in Madrid. Aplidin has received orphan drug designation by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). It is expected to be available in Australia, Southeast Asia 2018. No word yet on when this drug will be made available in the USA.
A randomized, open label multi-center clinical trial known as the ADMYRE study examined the efficacy of Aplidin in combination with dexamethasone versus dexamethasone alone. Though the trial is no longer accepting patients, more information about it can be found at the SparkCures site here.
More than 250 patients were enrolled in the study at 83 medical centers across 19 countries, including the United States, Europe and in Asia Pacific. All patients enrolled in the trial had relapsed or refractory multiple myeloma following a minimum of three and no more than six prior therapeutic regimens.
The success of Aplidin in combination with dexamethasone versus dexamethasone alone was evaluated by means of progression free survival (PFS) calculated using the IMWG (International Myeloma Working Group) criteria and other secondary efficacy endpoints.
Investigators are reporting a "statistically significant" 35% reduction in the risk of disease progression or death over the comparator arm. The study met its primary endpoint.
ST Asia Chief Executive Officer Mr. Carlo Montagner
described the latest trial results as "highly encouraging" and said he eagerly and said he eagerly awaited the full results of the study data to be disclosed.
"All data to date now suggests Aplidin may be an important new therapeutic for patients affected by this difficult to treat cancer.
"While multiple myeloma remains relatively rare, it is an insidious disease and patients typically exhaust treatment alternatives. ST Asia has been established to provide new therapeutics like this one to patients where there is a high unmet need."
Lead Australian investigator on the ADMYRE study and Director of Hematology at the Royal Melbourne Hospital, Professor Jeff Szer
, said: "These results are welcome as Aplidin appears to be another active agent with unique mechanisms of action in the management of multiple myeloma. While the outcomes for patients with multiple myeloma have improved greatly in recent years, they are still not ideal and this could pave the way for another treatment option for this difficult to manage disease. We are hopeful that Aplidin may soon provide another treatment option for those patients who have failed prior therapies and are running out of alternatives.
"We look forward to the release of full trial data which will give us a clearer picture of just how effective Aplidin may be for patients with refractory disease."
The trial data will be presented at an upcoming scientific meeting, according to the company.
Find All Refractory Myeloma Clinical Trials