*.- 24 de octubre de 2008: La Food and Drug Administration (FDA) Aceptó la Propuesta de PharmaMar, del Grupo Zeltia, sobre el proceso de producción de Aplidin® .
*.- En Junio de 2010 inicia dicha Fase III ADMIRE con 250 Pacientes en 65 Hospitales repartidos entre EEUU , Australia , Austria , Belgica , Republica Checa , Francia , Alemania , Grecia , Irlanda , Italia , Holanda , Portugal , Reino Unido y España .
*.- Aplidin para esta indicación posee el Status de Orphan drug , tanto en EEUU como en EU , lo cual le otorga varias ventajas ... una de ellas es la exclusividad de mercado en caso de aprobación de 7 años en EEUU y 10 años en EU ...
*.- Diciembre 2012 : Alcanza el objetivo inicial para la tasa de respuesta y el IDMC recomienda que se complete el ensayo de la Fase 3 (ADMYRE) .
*.- A Fecha de hoy son ya 6 los Hospitales que han comunicado que el Ensayo a " Terminated " .
*.- Estimated Study Completion Date: June 2014 .
*.- En Relación :
Plitidepsin (Aplidin) is intended to be used in combination with dexamethasone as third line therapy for the treatment of patients with multiple myeloma (MM). If licensed, it would provide an additional treatment option for this patient group. Plitidepsin is a cyclic depsipeptide identified from the Mediterranean marine tunicate, Aplidium albicans.
MM develops from plasma cells in the bone marrow and is the 17th most common cancer in the UK, accounting for around 1.5% of all new cases. Median survival for MM is approximately 3 to 5 years. In 2011, 2,330 deaths from MM were registered in England and Wales, 86% of which were in people aged 65 and over. The latest prevalence data suggests that at the end of 2006 there were 12,465 patients alive up to 10 years after their diagnosis. In 2009, 4,270 people were diagnosed with MM (ICD-10: C90) in England and Wales, giving a crude incidence rate of 8 per 100,000 population.
Treatment regimens for MM will be patient specific and dependent on performance status, eligibility for high dose chemotherapy with stem cell transplantation support, and frailty. There is no standard treatment option for patients who fail both bortezomib- and lenalidomide-based regimens. Plitidepsin is currently in a phase III clinical trial comparing its effect on MM against dexamethasone. This trial is expected to report in June 2014.