Research & Development

Seliciclib (CYC202)

Cyclacel Pharmaceuticals' drug candidate, seliciclib, is a novel, first-in-class, orally available, cyclin dependent kinase (CDK) inhibitor. The compound selectively inhibits multiple enzyme targets - CDK2, 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 control.

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 Pharmaceuticals 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.

Topline results from APPRAISE, the Company's Phase 2b, randomized discontinuation, double-blinded, placebo-controlled, study of oral seliciclib capsules in non-small cell lung cancer (NSCLC) demonstrated no difference between the seliciclib and placebo arms in terms of PFS (48 versus 53 days respectively) but a substantial increase in OS was observed (388 versus 218 days respectively). APPRAISE is a learning trial evaluating progression free survival (PFS) and overall survival (OS) of seliciclib as a monotherapy in heavily pretreated patients with non-small cell lung cancer. Full results will be reported at a future publication or medical conference.

Following unblinding of the APPRAISE data, Cyclacel Pharmaceuticals commissioned a central laboratory analysis of available biopsy samples from approximately 130 patients in APPRAISE who gave their informed consent. The purpose of the biomarker analysis is to examine the mutational status of the lung cancers and explore a possible molecular rationale for the difference in overall survival.

Seliciclib is also being evaluated in a Phase 2 study as a single agent in patients with nasopharyngeal cancer.

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