Cyclacel Pharmaceuticals has enrolled the first patient in an investigator sponsored trial (IST) of its oral cyclin dependent kinase (CDK) inhibitor seliciclib in Cushing’s disease (CD).
Seliciclib is an orally-available CDK2/9 inhibitor that was already assessed in around 450 patients and is currently being evaluated in combination with Cyclacel’s orally-available sapacitabine in patients with solid tumours.
CD is an endocrine disorder caused by adrenocorticotropin (ACTH)-producing pituitary tumours that will result in obesity, diabetes, hypertension, osteoporosis and increased risk of death if inadequately controlled.
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has provided grant for Cedars-Sinai’s clinicians to assess seliciclib.
Cedars-Sinai medical faculty dean and principal investigator Dr Shlomo Melmed said: "Cushing’s disease is a serious debilitating endocrine disorder with limited treatment options for patients.
"We believe that seliciclib is unique among clinical stage CDK inhibitors in its potential effectiveness to treat this disease."
The study is a Phase II proof-of-concept, open-label and single arm trial designed to evaluate the safety and efficacy of seliciclib in CD.
The company will enrol 16 patients with de novo, persistent or recurrent CD in the study, which will receive seliciclib for four weeks prior to standard-of-care treatment.
According to the firm, the trial’s primary objective is to establish the efficacy of seliciclib on normalising urinary free cortisol levels in patients with CD.