UK-based biotechnology firm Tiziana Life Sciences has reported positive long-term results from two Phase II clinical trials of its targeted therapy candidate milciclib evaluated for the treatment of thymic carcinoma and thymoma.
Milciclib is a small molecule pan-inhibitor of cyclin-dependent kinases (CDKs), including CDK1, CDK4, CDK5, and CDK7.
The therapy candidate has met the primary endpoint of progression free survival (PFS) in both CDKO-125A-006 and CDKO-125A-007 trials, and was found to be safe and well-tolerated following exposure for about five years.
Conducted in the US, France and Italy, CDKO-125A-006 included 72 thymic carcinoma patients and CDKO-125A-007 assessed 30 subjects with thymoma.
Tiziana Life Sciences CEO and chief scientific officer Kunwar Shailubhai said: “Data from these two clinical studies demonstrating efficacy and long-term safety is a major milestone in clinical development of milciclib.
“We will work with regulatory agencies in the US and Europe to develop plans to bring these first-in-class therapies to patients in need as soon as possible.”
During CDKO-125A-006, 56 of the total patients had median PFS of 5.78 months, while it was 5.65 months in case of 18 subjects in the CDKO-125A-007 trial.
Milciclib also met a secondary endpoint of overall survival (OS), with 50% of thymic carcinoma patients experiencing median OS of 24.44 months and 54.5% of thymoma patients having 48 months of OS.
Out of a total of seven patients who had been continuing treatment with milciclib for more than two years, two participants were exposed to the drug for around five years to establish its long-term safety.