Cyclacel begins dosing in investigator sponsored trial of seliciclib to treat Cushing’s disease

The trial is being carried out by clinicians at Cedars-Sinai, Los Angeles, who were awarded a grant from The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to evaluate seliciclib, a CDK2/9 inhibitor, to treat certain cancers, as a potential therapy for CD.

CD is caused by adrenocorticotropin (ACTH)-producing pituitary tumors, often leading to obesity, diabetes, hypertension, osteoporosis and increased risk of death if inadequately controlled.

Cedars-Sinai Burns and Allen Research Institute director and Medical Faculty principal investigator and dean 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. Its mechanism of action has a dual effect as it impacts tumor growth by decreasing the levels and activity of cyclin E, as well as inhibiting ACTH production.

"If our trial with seliciclib proves successful, it could lead to dramatically improved treatment outcomes for patients with Cushing’s disease."

The proof-of-concept, open-label, single arm Phase II trial is designed to evaluate the safety and efficacy of seliciclib in CD.

In the trial, 16 patients with de novo, persistent or recurrent CD will receive seliciclib for four weeks prior to standard-of-care treatment.

The trial’s primary objective is to establish the efficacy of seliciclib on normalizing urinary free cortisol levels in patients with CD.

The biopharmaceutical firm is focused on developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders.