Specialised Therapeutics Asia Pte Ltd (ST Asia), an international biopharmaceutical company,  has announced that the company will seek regulatory approvals for novel multiple myeloma drug Aplidin (plitidepsin) following the release of positive results in a pivotal phase 3 study.

A randomised, open label multi-centre clinical trial known as the ADMYRE study examined the efficacy of Aplidin (plitidepsin) in combination with dexamethasone versus dexamethasone alone.

More than 250 patients were enrolled in the study at 83 medical centres across 19 countries in the United States, Europe and in the Asia Pacific. All patients enrolled in the trial had relapsed or refractory multiple myeloma following a minimum of 3 and no more than 6 prior therapeutic regimens.

The efficacy of Aplidin (plitidepsin) in combination with dexamethasone versus dexamethasone alone was evaluated by means of 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 (p=0.0054). The study met its primary endpoint.

ST Asia chief executive officer Carlo Montagner described the latest trial results as "highly encouraging" and said he eagerly awaited the full results of the study data to be disclosed.

"We look forward to working with our European partner PharmaMar to ensure this valuable multiple myeloma therapy is available as soon as possible to patients in key South East Asia regions, as well as in Australia and New Zealand," he said.

"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 Haematology 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.

Plitidepsin is an investigational anticancer agent of marine origin, originally obtained from the ascidian Aplidium albicans. It specifically binds to the eEF1A2 and targets the non-canonical role of this protein, resulting in tumor cell death via apoptosis (programmed death). Plitidepsin is currently in clinical development for hematological cancers, including a phase III study in relapsed or refractory multiple myeloma, a phase Ib trial in relapsed or refractory multiple myeloma as a triple combination of plitidepsin, bortezomib and dexamethasone, and a phase II study in relapsed or refractory angioimmunoblastic T-cell lymphoma. Plitidepsin has received orphan drug designation by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).

ST Asia has exclusive rights to market and distribute Aplidin in Australia, Singapore and 12 other South East Asian countries under the terms of an arrangement with European partner PharmaMar.

Aplidin was the first drug licensed by ST Asia for the broader SE Asian market and is a first in class compound developed for the treatment of multiple myeloma and a type of T cell lymphoma.  It is PharmaMar's second anti-cancer drug candidate obtained from a marine organism.

The total population of South East Asian regions including Australia and New Zealand is approximately 650 million, with an estimated 300,000 people living with multiple myeloma overall and between 30,000 and 40,000 new cases of the disease diagnosed annually.

Specialised Therapeutics Asia Pte Ltd (ST Asia) is an international biopharmaceutical company established to provide pioneering healthcare solutions to patients throughout South East Asia, as well as in Australia and New Zealand.

Headquartered in Madrid, PharmaMar is a world-leading biopharmaceutical company in the discovery and development of innovative marine-derived anticancer drugs.