Oncopeptides Initiates Phase II Clinical Study with Melflufen in the Treatment of Multiple Myeloma Patients
Stockholm, Sweden August 20, 2013 – Oncopeptides AB, a company working to enhance oncology therapies, today announced that the first patient has been dosed as part of a Phase II study in multiple myeloma patients with its drug candidate melflufen (previously called J1).
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. Chief Medical Officer Dr Johan Harmenberg commented “Cytotoxic compounds form an integral part of combination treatment in malignant disease. Melphalan is part of the standard of care in multiple myeloma and improving this component with melflufen should result in significant patient benefit”.
Multiple myeloma is the second most common hematological cancer and manifests from an abnormality of plasma cells, usually in the bone marrow. Worldwide, more than 180,000 people are living with multiple myeloma and approximately 86,000 new cases are diagnosed annually (International Agency for Research on Cancer).
About Oncopeptides AB
Oncopeptides is a clinical stage pharmaceutical development company working to enhance oncology therapies, by creating cytosuperiors of existing basic cytotoxic compounds. Oncopeptides is targeting multiple myeloma as a first indication with its lead compound, named melflufen which is a cytosuperior of the chemotherapeutic alkylator melphalan.
A family of enzymes that is overexpressed at very high levels in cancer cells, such as multiple myeloma cells, cleaves melflufen so its active metabolite is entrapped at high concentrations within the diseased cells. This results in partially targeted delivery of the chemotherapeutic compound to the cancer cells, and thereby better treatment of the disease.
Primary cancer cells from patients representing twenty different types of cancers have been studied, including multiple myeloma, with melflufen showing 50- to 100-fold higher anti-tumor potency over melphalan.