Reportedly, the pivotal, international, multicenter Phase III clinical trial, called Admyre, is expected to enroll 300 patients in 60 medical centers across 20 countries (including the US, Europe, Asia and South America), with an estimated recruitment period of 24 months. The primary objective of Admyre is Progression Free Survival (PFS).
Aplidin is an antitumour agent of marine origin, originally isolated from the marine tunicate Aplidium albicans, and currently obtained by chemical synthesis.
PharmaMar claimed that Aplidin is its second most advanced compound. It is currently in phase II clinical trials for solid and haematological malignant neoplasias like multiple myeloma, T cell lymphoma and myelofibrosis.
The FDA has accepted the proposal made by PharmaMar for the production process of drug.
Aplidin has been designated an orphan drug by the European Commission (EC) and the FDA for acute lymphoblastic leukaemia (ALL) and multiple myeloma (MM).