.gif)
The US Food and Drug Administration (FDA) has granted Orphan Drug designation to Cleave Biosciences' lead drug candidate, CB-5083 for the treatment of multiple myeloma.
Multiple myeloma, also known as myeloma, is a haematologic cancer, or cancer of the blood, that develops in the plasma cells in bone marrow. It is the second most common blood cancer, after non-Hodgkin's lymphoma.
CB-5083 is a first-in-class, oral inhibitor of p97, a critical enzyme that controls various aspects of protein homeostasis. Cleave is currently evaluating CB-5083 in two phase 1 studies including one in patients with multiple myeloma, and one in patients with solid tumour malignancies.
Orphan designation is granted by the FDA Office of Orphan Products Development to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the US.
Cleave's ongoing studies include an open-label, phase 1 dose escalation/dose expansion trial to evaluate the safety, pharmacokinetics, pharmacodynamics and anti-tumour activity of CB-5083 in multiple myeloma patients who have relapsed/refractory or refractory disease after receiving two or more lines of therapy, including an immunomodulatory agent (IMiD) and a proteasome inhibitor. Cleave expects to enroll up to 60 patients at multiple US cancer centres that are part of the Multiple Myeloma Research Consortium.
Cleave Biosciences is a pioneer in the discovery and development of drugs that target protein homeostasis systems and have the potential to transform the treatment of people with difficult to treat solid tumours and hematologic malignancies.
Subscribe to PharmaTutor News Alerts by Email >>
