Cyclacel’s lead drug candidate, seliciclib, is a novel, first-in-class, orally available, cyclin dependent kinase (CDK) inhibitor. The compound selectively inhibits multiple enzyme targets - CDK2/E, CDK2/A, CDK7 and CDK9 - that are central to the process of cell division and cell cycle control. Preclinical studies have shown that the drug works by inducing cell apoptosis, or cell suicide, in multiple phases of the cell cycle.

To date, seliciclib has been evaluated in several Phase I and II studies and has shown early signs of anti-cancer activity in approximately 240 patients. Studies included a Phase I study in which single agent seliciclib was administered to patients with advanced NSCLC and two Phase IIa studies in which seliciclib was administered in combination with gemcitabine and cisplatin as first-line treatment and with docetaxel as second-line treatment in NSCLC. Seliciclib was also evaluated in a non-Cyclacel sponsored Phase I study in patients with nasopharyngeal cancer (NPC) with evidence of tumor shrinkage and concomitant reduction in copy counts of the EBV virus that is causally associated with the pathogenesis of NPC.

Seliciclib is currently being evaluated in the APPRAISE trial, a Phase 2b randomized double-blinded study to evaluate the efficacy and safety of the drug as a third line treatment in patients with NSCLC. The trial is using a randomized discontinuation trial design. Seliciclib is also being evaluated in a Phase 2 study as a single agent in patients with nasopharyngeal cancer.

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