Date: 2013-08-20
Type of information: Treatment of the first patient
phase: 2
Announcement: dosing of the first patient
Company: Oncopeptides (Sweden)
Product: melflufen (melphalan-flufenamide)
Action
mechanism: alkylating agent. Melphalan-flufenamide (melflufen) is a cytosuperior of the alkylating agent melphalan. It consists of melphalan conjugated to an amino acid, phenylalanine, creating a dipeptide. The intracellular cleavage of melflufen is caused by peptidases which liberate free melphalan within the cell, and a number of these peptidases are overexpressed in malignant cells.
Disease: multiple myeloma
Therapeutic area: Cancer - Oncology
Country: Denmark, Italy, the Netherlands, Sweden, USA
Trial
details: The trial is an open-label Phase II study designed to determine the level of efficacy of melflufen in combination with dexamethasone, for late stage, relapsing or relapsing/refractory patients. The primary end point is, best response in accordance with the International Myeloma Working Group criteria during up to eight cycles of treatment. The trial is being carried out across four centers in Europe (the Netherlands, Italy, Denmark and Sweden) and two in the USA. (NCT01897714)
The trial will include 35-50 patients and recruitment has commencs Q2 of 2013 across four centers in Europe and two in the US. Study read-out is expected late 2014.
Latest
news: * On August 20, 2013, Oncopeptides AB, a company working to enhance oncology therapies, has announced that the first patient has been dosed as part of a Phase II study in multiple myeloma patients with its drug candidate melflufen. Last May, the company has concluded a series A financing round to fund this phase II program.
