Oncopeptides AB, a clinical stage company developing a novel alkylator – melflufen – today announced that initial clinical data from the dose escalation part of a Phase I/II dose escalation/expansion trial is to be presented at the 56th ASH Annual Meeting and Exposition in San Francisco, CA. The Phase I objective, to establish the maximum tolerated dose (MTD), has been reached with the MTD determined at 40 mg melflufen in combination with dexamethasone and with no dose-limiting toxicity being observed in the first three dose cohorts (15, 25 and 40 mg).
The clinical results obtained to date will be presented on poster #2123, entitled ‘Determination of the MTD and Preliminary Results in an Ongoing Open-Label Phase I/IIa Study of the Safety and Efficacy of Melflufen and Dexamethasone in Combination for Patients with Relapsed and Relapsed-Refractory Multiple Myeloma (RRMM)’ at the conference.
CEO, Jakob Lindberg commented “The results to date really are encouraging and support us in our belief in the future of our lead compound as having the potential to bring significant clinical benefit to patients with multiple myeloma”.
Multiple myeloma is the second most common hematological cancer and worldwide more than 180,000 people are living with the disease, with approximately 86,000 new cases diagnosed annually (ref: International Agency for Research on Cancer).
The trial is being carried out across four centers in Europe (Sweden, Italy, the Netherlands and Denmark) and two in the USA (Boston, MA and Chapel Hill, NC).
About Oncopeptides AB
Oncopeptides is a clinical stage pharmaceutical development company working to enhance oncology therapies, by creating cytosuperiors of existing cytotoxic compounds. Oncopeptides is targeting multiple myeloma as a first indication with its lead compound, named melflufen, which is a chemotherapeutic alkylator.
A family of enzymes that are overexpressed at very high levels in cancer cells, such as multiple myeloma cells, cleave melflufen so that the alkylating moiety accumulates 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.