Two online abstracts from the studies were published at the virtual annual meeting of the American Society of Clinical Oncology 2020 (ASCO20).
A Phase 2a clinical trial with orally administered Milciclib in sorafenib-resistant hepatocellular carcinoma (HCC) patients met the primary endpoint of being well tolerated with manageable toxicities and no recorded drug-related deaths.
The secondary endpoint of clinical activity was also met with five patients taking the treatment for more than nine months for compassionate reasons.
“Results from the phase 2a clinical study demonstrating clinical activity in these advance cases of HCC are notable,” stated Prof. Angelo Sangiovanni, the principal investigator of the study at the prestigious Granda Ospedale Maggiore Policlinico in Milan.
“The fact that many of the treated patients continued with the treatment, even after completing 6 months duration of the study, is particularly very impressive.”
The second abstract reported preliminary clinical data from an ongoing investigator-originated trial of seven patients with a combination of orally administered Milciclib and Regorafenib in liver transplant patients with recurrent HCC.
Thus far, the study has shown mean AFP levels (a common tumor biomarker) reduced by approximately 20% within one month of treatment.
Prof. Erica Villa, site investigator at the Policlinico di Modena, said: “The positive clinical activity and impressive safety and tolerability of Milciclib in combination with Regorafenib in liver transplant patients with recurrent HCC is certainly noteworthy.
“Thus, clinical data from these two studies are very encouraging and warrant continued development of Milciclib, either as monotherapy or combination therapy.”