Clinical trials

Phase 2a Clinical Trial (CDKO-125a-010) for Milciclib as a Monotherapy for the Treatment of HCC

Completed a Phase 2a trial (CDKO-125a-010) of Milciclib safety and tolerability as a single therapy in sorafenib-resistant patients with HCC (https://clinicaltrials.gov/ct2/show/NCT01011439). 28 out of 31 treated patients were evaluable, 14 completed the 6-month duration study. Nine patients were approved to continue treatment under compassionate use by their respective ethical committees. Oral treatment with Milciclib was well-tolerated with manageable toxicities. No drug-related deaths were recorded. The most frequent drug-related adverse events such as: diarrhea, nausea, retinal hemorrhage, fatigue, asthenia, chills, ataxia, headache, rash.

MAJOR HIGHLIGHTS OF THE CLINICAL DATA

Primary endpoint: Safety

Treatment was well-tolerated and adverse events were manageable with no drug related deaths in the trial

Secondary endpoints: Efficacy

• Median Time-to-Progression was 5.9 months
• Patients with stable disease – 57%
• Patients showed clinical benefit response – 61%